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// MAY 2015 Look ahead to Lisbon ESHRE news Best of ESHRE & ASRM 2015

Developments in infertility counselling The case for patient centred treatment

On the fertility journey

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All rights reserved. The opinions expressed in this magazine are those of the authors and/or persons interviewed and do not necessarily reflect the views of ESHRE. Cover picture: Getty Images

MAY 2015

EXECUTIVE COMMITTEE // Chairman Juha Tapanainen (FI) // Chairman Elect Kersti Lundin (SE) // Members Helen Kendrew (GB), Carlos Calhaz-Jorge (PT), Roy Farquharson (GB), Anis Feki (CH), Georg Griesinger (DE),Grigoris Grimbizis (GR), Nils Lambalk (NL), Cristina Magli (IT), Tatjana Motrenko (ME), Jacques De Mouzon (FR), Andres Salumets (EE), Petra De Sutter (BE) Ex-officio members // Anna Veiga (ES, Past Chairman), Timur Gurgan (TR, SIG Sub-committee)FOCUS ON REPRODUCTION EDITORIAL COMMITTEE // Susanna Apter, Christine Bauquis, Bruno Van den Eede, Hans Evers,Roy Farquharson, Anis Feki, Joep Geraedts, Kersti Lundin, Juha Tapanainen, Anna Veiga, Simon Brown (Editor)FOCUS ON REPRODUCTION is published by The European Society of Human Reproduction and Embryology, Meerstraat 60,Grimbergen, Belgium // www.eshre.eu


ESHRE activities have remained brisk during the first months of this year.Several meetings and workshops have been held with many memberscommendably taking part. The fourth ‘Best of ESHRE & ASRM’ meeting inNew York in early March was a great success. A record number of more than900 attended, with 300 from Europe. The scientific programme proved bothinteresting and practical, which has been the purpose of these joint eventsfrom the beginning. In the future the Best of meetings will be held every twoyears, with the next in Europe in 2017.

This is my last Chairman’s Introduction to Focus on Reproduction. Asexpected, my term as Chairman of ESHRE has passed quickly. Most of thetime has passed in everyday affairs, but many new activities have beeninitiated. I am particularly pleased that the e-learning project has now begunin earnest, that certification and accreditation programmes have expanded,and that ESHRE has taken part in numerous science policy issues as an activecontributor. Several practical changes have been made for the AnnualMeeting, perhaps the most visible a paperless congress for Lisbon. Please beprepared for that and read the instructions on the website.

The first ESHRE grant initiated by our Past Chairman Anna Veiga wasawarded late last year and will be officially handed to the winner at theOpening Ceremony in Lisbon. However, not all major objectives have beenmet and the new Executive Committee will have important issues to resolve.The Annual Meeting and Human Reproduction journals are the mostimportant source of income for the Society, and competition for funding andin journal publishing will get tougher. This will need special attention andcareful planning.

One of the most enjoyable things about my chairmanship has been gettingto know so many hard working professionals who put themselves out for thesake of a common good. With that in mind, I would like to thank allmembers of the the Executive Committee and the officers of our manycommittees and journals with whom I have worked in the past four years. Inparticular, I wish to thank Anna Veiga, who leaves the ExCo, and KerstiLundin, who will take over as Chairman in Lisbon. They have supported meunconditionally and helped in every way. I will continue as Past Chairman forthe next two years. Special thanks go to Bruno and his staff at Central Office.I find it hard to imagine a more loyal and effective team.

All the omens suggest that the Annual Meeting in Lisbon will be anotherhuge success. More than 1800 abstracts were submitted, which usuallypredicts a big attendance. So don’t forget to join the get-together on Tuesdayevening after the charity run, to meet friends old and new, and enjoy goodfood, drinks and music - and all at an affordable price! See you there.

Juha TapanainenESHRE Chairman 2013-2015

CONTENTS

CHAIRMAN’S INTRODUCTION

// MAY 2015

LOOK AHEAD TO LISBON 2015 4

AGM AND NEW EXECUTIVE COMMITTEE 5

HONORARY MEMBERS 2015 7

HUMAN REPRODUCTION KEYNOTE LECTURE 8

BEST OF ESHRE and ASRM 2015 9

ESHRE NEWS 12

IN PROFILE: RICHARD SHARPE 19

REGULATION AND REIMBURSEMENT IN EUROPE 22

CAMPUS UPDATE ON PGS 32

FROM THE SPECIAL INTEREST GROUPS 34

LAST WORD 40Synthetic babies?

PATIENT CENTREDNESS 25Jan Kremer on putting patients centre stage

THE FUTURE OF FERTILITY COUNSELLING 28Uschi Van den Broeck and Petra Thorn

WHAT PATIENT ORGANISATIONS CAN DO 30Clare Lewis-Jones on the benefits of getting together


ANNUAL MEETING 2015

4 Focus on Reproduction // MAY 2015

A total of 230 abstracts of original studies - from arecord total of 1800 submissions - have been selectedfor oral presentation in Lisbon. A further 800 abstractshave been selected for poster presentation.

The total of abstracts submitted marks anotherrecord entry and reflects the very high standards nowrequired for selection. As ever, submissions wererefereed blind by a selection committee, whichincluded, among others, the co-ordinators of ESHRE’s12 Special Interest Groups. Selection for the oral orposter programme was dependent entirely on thecommittee’s score, and represented for oralpresentation an acceptance rate of around 12%.

A total of 360 abstracts were received in the categoryof embryology, and 317 in reproductiveendocrinology, as ever ESHRE’s two leading categoriesas reflected in membership interests. However,considerable interest was evident in andrology (192submissions), female infertility (171), endometriosis(152), and reproductive genetics (124).

Nationally, the highest number of abstracts camefrom the UK (135 submissions), followed by Italy(125), Spain (123), China (123), Japan (118), and

Turkey (105). The ever-growing presence of China andJapan in the scientific programme of an ESHREAnnual Meeting was described as a welcomedevelopment by the ESHRE Chairman, a trend alsoevident in submissions to the journals. Europe, ofcourse, remains the meeting’s most prolific source ofabstracts, with around 1000 submitted, but Asia is nowresponsible for more than 500.

The main scientific programme of this paper-freemeeting is now in place and will begin as customarywith the Robert G Edwards keynote session featuring

Lisbon abstractsubmissionsclimb to yetanother record-breaking peak

All change for ESHRE’s first paper-free Annual MeetingThe programme for this year’s Annual Meeting will beavailable in digital format, with the former abstract andprogramme books now replaced by electronicmaterial. There will be three access options: A PDF of the programme and abstractbooks (the closest to what regular participantsare familiar with). An itinerary planner to check theprogramme and presentations, read abstractsand compose an itinerary. An app for mobile devices with the same

functions as the itinerary planner but many additionalfeatures to create a personalised congress (QR code below).

The app will allow note-taking, presentation-rating during the sessions, and postingdocuments to a virtual library. A continuousnotification service will keep participants up todate with congress news, while a listing ofcongress delegates will allow exchange ofmessages to other participants.iPad hire on site will be available for those

without a device and choosing the app option.


MAY 2015 // Focus on Reproduction 5

The main programme will comprise a series ofinvited presentations on topics of current interest anddevelopment. Notable among these will be a Tuesdaysession (planned by the journal Molecular HumanReproduction) on the prevention of mitochondrialdisease in which Professor Mary Herbert from the

the Human Reproduction lecture. The subject andlecturer are derived from the paper with the highestnumber of full-text downloads during the first sixmonths of publication in Human Reproductionbetween January 2013 and June 2014. You can findmore details on page 8.

Agenda of the General Assembly of MembersTo be held on Tuesday 16th June 2015, from 18.00 to 19.00, Room Braga, FIL, Internation Fair Lisbon, Portugal, venue of the 31st Annual Meeting.1. Minutes of the last meeting (held in Munich and published in Focus on Reproduction, September 2014)2. Matters arising3. Membership of the Society 4. Society activities

- Annual meetings - Campus meetings- Studies and data collection - Accreditation and certification- Special Interest Groups and Task Forces

5. Human Reproduction journals6. Paramedical Group7. Financial report8. Ratification of the new Executive Committee

- Roy Farquharson to be elected as Chairman-elect and retirement of Anna Veiga as immediate Past Chairman- Carlos Calhaz-Jorge (PT), Jacques De Mouzon (FR), Anis Feki (CH), Niels Lambalk (NL) and Cristina Magli (IT) to step down as members having served two two-year terms

- Basak Balaban (TK), Mariëtte Goddijn (NL), Borut Kovacic (SI), Nick Macklon (GB) and Rita Vassena (ES) as new members- Petra De Sutter (BE), George Griesinger (DE), Grigoris Grimbizis (GR), Tatjana Motrenko (ME) and Andres Salumets (EE) to serve a second two-year term as members- Cristina Magli (IT) to become an ex officio member as Chair of the SIG & TF Sub-committee

9. Retirement of the Chairman, Juha Tapanainen (FI), and installation of the new Chairman, Kersti Lundon (SE)10. Election of the Honorary Members for 201611. Any other business 12. Date of the next Annual General Assembly

GENERAL ASSEMBLY TO RATIFY SELECTION OF FIVE NEW ExCo MEMBERS

Basak Balaban is anembryologist and headof the IVF lab at theAmerican Hospital inIstanbul. As a memberfor Turkey, she joinedESHRE’s Committee ofNationalRepresentatives in2008. She was Chair ofAlpha - Scientists inReproductive Medicinebetween 2008 and 2012,and is currently Chairof the Turkish Societyof ClinicalEmbryologists.

Mariëtte Goddijn is aconsultant gynecologistat the Centre forReproductive Medicineof AMC Amsterdam.Her special interest isrecurrent miscarriage,for which she isprincipal invesigator.Mariëtte was Co-ordinator of ESHRE’sSIG Early Pregnancyfrom 2012 to 2014, andled the reviewcommittee for ESHRE’slatest recurrentmiscarriage guidelines.

Borut Kovacic is headof the reproductivebiology lab at theUniversity MedicalCentre, Maribor,Slovenia, and AssociateProfessor of CellBiology at theUniversity of Ljubljana.He has representedSlovenia on ESHRE’sCommittee of NationalRepresentatives and iscurrently a member ofESHRE’s embryologycertificationcommittee.

Nick Macklon isProfessor of Obstetricsand Gynaecology at theUniversity ofSouthampton, UK, and Director of theComplete FertilityCentre, Southampton.Nick is a past Co-ordinator of ESHRE’sSIG ReproductiveEndocrinology, andpresently holds VisitingProfessorships at theUniversities ofAdelaide, Australia,and Copenhagen.

Rita Vassena isScientific Director ofthe Clinica EUGIN inBarcelona, and chair ofits ethical committeefor clinical research.She was formerlySenior Researcher atthe Centre forRegenerative Medicineof the National StemCell Bank, Spain. Ritahas been Co-ordinatorof ESHRE’s SIG StemCells since 2013, andhas published widely inreproductive science.



Wellcome Trust Centre for Mitochondrial Research inNewcastle, UK, will review the techniques recentlygranted legal approval in Britain (see page 15). Therewill also be much clinical interest in two presentationsin a hot-topic session on ‘safer and better’ IVF - on thepromise of an OHSS-free clinic and the potentialbenefits of a freeze-all embryo policy.

This year will also mark the first exchange sessionwith the Chinese Society for Reproductive Medicine.ESHRE exchange sessions have long been held withthe ASRM (since 1993) and Fertility Society ofAustralia (since 1996), but 2015 will be a first forChina. Topics in the programme will be genomic andtranscriptome analysis of oocytes and embryos, and

PGD by non-invasive haplotype screening.This year’s social programme has moved with the

times and will be more about the community ofESHRE than mere socialising. Thus, while Sundayevening’s opening ceremony and welcome receptionwill remain as before, the congress party has beenreshaped as an ESHRE community evening. Thisincludes the charity run after the main programme onTuesday and, following the run, a chance for everyoneto say hello, for scientists to meet clinicians, juniors tomeet their seniors, and of course for everyone to meetfriends and colleagues. Registration details are on theESHRE website.

The General Assembly of Members, as detailed inthe box on page 5, will see the introduction of a newExecutive Committee for ESHRE and a farewell tothose members who have served two two-year terms -Carlos Calhaz-Jorge (a joint organiser of this meetingin Lisbon), Jacques De Mouzon, Anis Feki, and NielsLambalk. The Italian embryologist Cristina Magli willremain an ex officio member of the ExCo as Chairmanof the SIG/Task Force sub-committee.

The Swedish embryologist Kersti Lundin, whose pastresponsibilities with ESHRE have includeddevelopment of the certification programme forembryologists and co-ordination of the SIGEmbryology, will take over as Chairman of the Societyfrom Juha Tapanainen, and the British gynaecologistRoy Farquharson has been selected for ratification asChairman Elect. Farquharson, already a member of theExecutive Committee with a responsibility for theaccreditation of centres for EBCOG sub-specialisttraining and a past Co-ordinator of the SIG EarlyPregnancy, would thus become Chairman of theSociety in 2017 - and, as a clinician, would continuethe ESHRE tradition of alternating the interests of itschairmen between science and clinical medicine.

New figures in the hot seats. At this year’s General Assembly the Swedish embryologist Kersti Lundin will take over as ESHRE Chairman,while the UK gynaecologist Roy Farquharson has been selected for

ratification as Chairman Elect.



ANNUAL MEETING 2015

Two stalwarts of ESHREawarded honorarymembership in 2015Past MHR editor Steve Hillier and formerESHRE Chairman Paul Devroey will receivetheir awards at this year’s Opening Ceremony

Although Paul Devroey, the second recipient of honorarymembership in 2015, was ESHRE's tenth chairman, serving from2005 to 2007, his history with ESHRE stretched back to the veryfoundation of the Society. He represented Belgium on the first andsecond Advisory Committees (from 1986 to 1990) and, with AndréVan Steirteghem, organised ESHRE’s second annual meeting inBrussels in 1986 (having served on the organising committee forthe first meeting in Bonn in 1985). He was also a member of thesecond ethics committee formed in 1988. Devroey joined theExecutive Committee in 1993, and was treasurer from 1993 to1995, when he became Co-ordinator of the Special Interest Groups(until 2003).Paul Devroey qualified in medicine in 1971 at the Dutch-

speaking Catholic University of Leuven. In 1989 he was awardedhis PhD (on oocyte donation) at the Dutch-speaking FreeUniversity of Brussels (VUB), and it was here two years later thathe pioneered the technique of intracytoplasmic sperm injectionwith Van Steirteghem. Following trials in animal models, withethical approval secured and pre-conditions in place (karyotyping,prenatal diagnosis), the VUB’s first ICSI embryo had beentransferred in 1991, and the first baby born in January 1992. Theevent was reported (along with four pregnancies) to the Lancet (byPalermo, Joris, Devroey and Van Steirteghem). Data from allsubsequent patient series appeared in Human Reproduction, whichno doubt had a lasting effect on the journal’s impact factor.Paul Devroey retired from his posts as Professor of Reproductive

Medicine and Clinical Director of the Centre for ReproductiveMedicine at the VUB in 2011. He is a past president of the BelgianSociety of Reproductive Medicine, a current member of theeditorial board of Fertility and Sterility, and a former associateeditor of Human Reproduction Update. And even in ‘retirement’ heremains as busy as ever. He is still an active member of ESHRE’sEthics & Law committees, and of its position paper writing groups- which he has always described as some of ESHRE’s mostimportant achievements.He is presently director of medical education of the International

Federation of Fertility Societies (IFFS) and has established aleading clinical interest in IVF safety, notably in the promise of an‘OHSS-free clinic’.

Steve Hillier, who will receive honorary membership ofESHRE this year, was also honoured by the Queen ofEngland in January with an OBE for services tointernational higher education. Over the past 15 years,Hillier had established strong academic links between hisown University of Edinburgh and overseas institutions,helping develop international centres of excellence withRussia, China, India, Latin America and in Islamic studies.Hillier retired last year from his position as Vice PrincipalInternational at the University of Edinburgh but remainsactive in reproductive science as Emeritus Professor, witha personal chair in reproductive endocrinology.

Hillier was editor-in-chief of Molecular HumanReproduction from 2007 to 2013, and saw the journal’simpact factor rise to 4.5 during his editoriship. It was alsoHillier who rebranded the journal as MHR, in a bid tomake the title more more memorable and ‘more loved’.

Throughout his illustrious career in Edinburgh heenjoyed 22 years of uninterrupted funding from the UK’sMedical Research Council, totalling around £4 million.His work, which explains many of the cellular pathways

controlling ovulation - and helped explain whywomen normally ovulate only one egg

in each menstrual cycle - wasdescribed at a retirement

symposium last year as‘translational endocrinology’,for many of his findings, withemphasis on steroid hormonephysiology, would indeedhave clinical application,particularly in ovarianstimulation for IVF and inovarian cancer.

As a prolific author andinvestigator, Hillier

published the ‘medicaltextbook of the year’

in 1996, ScientificEssentials ofReproductiveMedicine.


Once again, the Robert Edwards keynote sessionwhich opens the Annual Meeting will be among thebest attended presentations at any congress ever inreproductive medicine. The session, which includesthe Human Reproduction keynote lecture, has quicklyestablished a record-breaking tradition of bumpercrowds and maximum attendance to get the congressunder way. Last year in Munich around 3000 packedthe auditorium for Chris Barratt’s lecture on calcium-signalling pathways in human sperm hyperactivation,a welcome return to the basic science of reproduction.

This year’s Human Reproduction lecture is a first inreproductive epidemiology, and will featurepreconceptional stress and its association withinfertility as reflected in data from the LIFE study, aprospective investigation performed with fundingfrom the US National Institute of Child Healthand Human Development.1

The report of the study had thehighest number of full-textdownloads during the first sixmonths of publication of all originalarticles published in HumanReproduction between January2013 and June 2014.

The lecture will be given inLisbon by the group’s principalinvestigator, Courtney Lynch fromthe Ohio State University WexnerMedical Center in Columbus,USA. The paper was downloadedon more than 3300 occasions fromthe Human Reproduction website,far more than any other during thesix-months assessment period.

The study, which was performedprospectively at two US sites in

Texas and Michigan, began in 2005 with theenrolment of 501 couples trying to conceive andfollowed-up for up to 12 months and throughpregnancy if it occurred. The aim, Lynch told Focus onReproduction, was to clarify the ‘controversial’ rolewhich stress plays in infertility. ‘The causes ofinfertility have become less relevant in many ways,given that ART is so successful in overcoming manyfertility problems,’ she said, ‘but continuing to explainthe factors associated with optimising natural fertilityis extremely important.’

The study itself used data from the LIFE(Longitudinal Investigation of Fertility and theEnvironment) study in which female subjects providedsaliva samples at enrollment and following the firststudy menses for measurement of cortisol and alpha-amylase, known biomarkers of stress.

Results of the analysis, which were examined inrelation to time to pregnancy and covariate data self-recorded in daily journals, showed that higher levels ofstress as measured by salivary alpha-amylase (but notcortisol) were associated with a longer time-to-pregnancy and an increased risk of infertility.

‘This was the first US study to demonstrate aprospective association between salivary stressbiomarkers and time to pregnancy,’ says Lynch, ‘andthe first in the world to observe an association withinfertility.’

After adjustments (for female age, race, income, anduse of alcohol, caffeine and cigarettes), women in thehighest tertile measurement of alpha-amylase had a29% lower fecundity than women in the lowest tertile

(OR 0.71; 95% CI 0.51-1.00), which translated intoa more than two-fold increased risk of infertility.

Frequency of sexual intercourse and thetiming of ovulation did not differ

between high and low stresswomen, suggesting these were notthe mechanisms for the observedassociation.

1. Lynch CD, Sundaraam R, MaisogJM, et al. Preconception stressincreases the risk of infertility: resultsfrom a couple-based prospectivecohort study—the LIFE study. HumReprod 2014; 29: 1067-1075.


ANNUAL MEETING 2015

Stress affects fertility:epidemiology datapresented at openingkeynote lecture Human Reproduction paper with the most full-text downloads in 2013 First study to find association betweenbiomarkers for stress and fertility

BEST OF ESHRE & ASRM 2015

Courtney Lynch: ‘The first US studyto demonstrate a prospective

association between salivary stress biomarkers and time to pregnancy.’


There was record registration of more than 900 participants for this fourthBest of ESHRE & ASRM meeting, held in New York in March.


Those who attended last year’s Best of ESHRE &ASRM in Cortina, Italy, will know that the weather forthis increasingly popular meeting is cold with snow.Just like New York in 2015 - though the buildings werea little taller, and there was no skiing on Broadway.

The format of the meeting, like the weather, has alsosettled into a familiar pattern - of ‘cutting-edge’ andplenary lectures, and of back-to-back presentationsand debates. Because the latter are presented by adistinguished American and European, there is a riskthat the format itself encourages a transatlantic rivalrywhich doesn’t really exist, but which may neverthelessbe interpreted as representative of the opinion andpractice of the two continents.

The potential for such a dichotomy of view was setup in the opening session when Glenn Schattmanfrom Weill Cornell Medical College in New York waspitched against Bart Fauser of Utrecht to debate thecontentious proposition that ART results in the USAare ‘better’ than in Europe. Schattman, drawing hisevidence from the database of SART and a fewmulticentre trials, not surprisingly agreed. Recenttrials of urinary and recombinant FSH with fixedprotocols, he proposed, had shown better outcomes inthe US centres than in the European, as well as moreoocytes and better quality embryos. Live birth rate inthe US centres of one such trial was 38.2%, while inEuropean centres 27.6%. And the explanation,Schattman suggested, was that ‘the qualityof care may be different’ - in screening andin the lab. ‘Every step is better,’ he said, andespecially in the simple paradigm of thefresh original cycle.

But this, challenged Fauser, is the wrongparadigm. ‘This is not a discussion aboutlive birth rates, it’s about multiplepregnancies, safety and cost. Glenn,’ saidFauser, turning benignly to his opponent,‘you’re watching the movie, butunfortunately it’s the wrong movie.’

Fauser’s approach, putativelyrepresenting what goes on in Europe, thusdefined ‘success’ as dependent on livebirth, multiplicity, the type of patienttreated, complications, cryopreservation,cost and a cumulative outcome from the

first started cycle. Fauser’s prescription for optimisingIVF was that it should be effective as measured bydelivery of a healthy baby over a definitive course oftime, safe in terms of multiplicity and complications tomother and baby, and cost effective when indicative ofbroad access to treatment. Such parameters, heproposed, should substitute any reliance on oocytenumber, embryo number, implantation rate andpregnancy rate per cycle or transfer as markers of‘success’.

This, like most others, was nevertheless a back-to-back session in which there was much common

ground between the two protagonists, inwhich entertainment was as much apriority as information. However, thedebate which followed - on the ability (ifnot potential) of PGS to improve live birthrates in IVF - made little concession totransatlantic harmony, and eventuallybecame contentious over patient costs.The debate began with Colorado’s WilliamSchoolcraft, whose work has done somuch to improve and validatetechnologies in PGS, proposing that thecomprehensive chromosome screening(CCS) of embryos is of genuine benefit inIVF. Yet even he conceded at the outsetthat screening embryos by FISH for alimited number of chromosomes had beendisappointing. ‘But that’s irrelevant,’ he

BEST OF ESHRE & ASRM 2015

More harmony than rivalry, despite anemphasis on transatlantic ‘debate’ More than 900 participants in New York Cutting-edge moments in ovarian tissue transplantation and mitochondrial replacement

The heart of the matter: Are IVF resultsbetter in the USA than in Europe? BartFauser, left, and Glenn Schattman,



said, ‘that’s history.’ Now, a ‘convergence’ oftechnologies had moved forward such that by 2011Schoolcraft and colleagues could report that acombination of trophectoderm biopsy, blastocystvitrification, and single-nucleotide polymorphism(SNP) array technology for CCS does indeed resultin high implantation and live birth rates. Such anoutcome, Schoolcraft proposed, opened the doornot just to better outcomes but also to the practicalapplication of single embryo transfer. With thetechnology now moving on to next generationsequencing, Schoolcraft noted emerging commonfeatures to the various techniques - but notably thatblastocyst biopsy ‘has many advantages’. He noted arecent systematic review of blastocyst biopsy forCCS (compared with routine IVF) which found theformer associated with higher implantation andongoing pregnancy rates when the same number ofembryos is transferred, and improved embryoselection for SET and sharply decreased multiplerates. This finding, said Schoolcraft, is of clinicalimportance, because the better embryo selectionmade possible by CCS now makes SET a clinicaloption for older women. The disadvantageconferred by age seems removed. ‘With thedevelopment of CCS, blastocyst vitrification andtrophectoderm biopsy,’ said Schoolcraft, ‘olderwomen have the opportunity of elective single-embryo transfer with live birth rates as high as thosereported for younger good-prognosis infertilitypatients.’

In response, the Amsterdam biologist SjoerdRepping opened his comments with a denial that PGScould ever improve outcomes in IVF. ‘Can PGSimprove live birth rates?’ he asked rhetorically. ‘Itnever will.’

Repping, of course, was a member of theAmsterdam group whose 2007 RCT in the NewEngland Journal of Medicine hammered the first nailsinto the coffin of PGS with FISH. Yet at the time heand his colleagues were severely criticised (ontechnicalities) by those promoting PGS, particularly inthe USA. Now, for Repping if not for Schoolcraft,these lessons of history were a salutary warning not tomake the same mistake twice. And for Repping theselessons were underscored by the arguments ofevidence-based medicine,ulterior motive, and logic.

Thus, with FISH consigned tohistory, PGS has entered itssecond phase with a shift topolar body or blastocyst cellanalysis and array CGH. Butargued Repping, most of thetrials in support of these second-phase technologies are alsoflawed. For example, the study ofScott et al of 2013 (an RCT ofblastocyst biopsy with CCS) wascriticised by Repping as only ingood prognosis patients, withrandomisation on day 5, and

with all subjects progressing to transfer. What it finally came down to, of course, was the

contentious question of recent years of how tointroduce new technologies into IVF. Reppingunsurprisingly supported the gradual approach inwhich these ‘potentially risky reproductivetechnologies’ remained the subject of research untilafter preclinical investigation, clinical trials andfollow-up studies.

There was potential for similar confrontation in adebate in which time-lapse imaging was proposed as‘superior to classical morphology’ for embryoselection. In this case, however, the proponent of thenew technology was European and his evidencederived from a European RCT. Giovanni Coticchiofrom Monza, Italy, first proposed that time-lapseimaging can detect aberrations in the embryo whichmorphology cannot do - notably ‘reverse cleavage’and multinucleation. However, his strongest evidencecame from the ‘long awaited’ RCT of Rubio andcolleagues at IVI in Spain, finally published inFertility and Sterility in November last year. Resultsfrom this study, which included 843 patients whoseembryo development was assessed by morphology ora time-lapse monitoring system, showed a higherongoing pregnancy rate in the time-lapse group(51% vs 41% per treated cycle), with lowerpregnancy loss and higher implantation rates.However, as Coticchio himself asked, were the betterresults achieved by time-lapse imaging itself, or bythe better culture and observation conditions?

This question was at the heart of his opponent’spresentation, but Catherine Racowski from HarvardMedical School was unable to find an answer in theavailable evidence - including the IVI trial. ‘I believewe are still in the development/calibration phase,’ shesaid, noting that the majority of studies areretrospective (though not Rubio et al) andheterogeneous in their design. However, her greatestcriticisms came in the design of the IVI trial in which,she said, 30 of the patients randomised to morphologywere placed on request in the time-lapse group.Moreover, she added, the study had a high risk of biasfor selection, attrition, selective reporting andperformance – particularly in that different incubatorswere used for the two groups. No study, sais Racowski,

has yet reported increased live birthrate as its endpoint.

There was similarly littlecontention in a back-to-backsession on the treatment ofunexplained infertility. OwenDavies from Weill Cornell MedicalCollege in New York favoured the‘expedited’ approach, even ifrecognising that the slow approachproposed by Roy Homburg wasassociated with lower risk of OHSS.A quick recourse to IVF would,however, reduce the risk ofmultiples and provide a betteropportunity of embryo selection

A debate which becamecontentious, on the

benefits of PGS. Above,William Schoolcraft,and Sjoerd Repping.

Cutting-edge lectures on mitochondrial replacement fromMary Herbert and on robotically assisted ovarian tissue

transplantation from Kutluk Oktay.



Roy Homburg, left, found no need to rush to IVF inunexplained infertility, while Catherine Racowski stillconsidered time-lapse imaging in a developmental phase.

and SET (while stimulation with a GnRH antagonistwould rescue the OHSS threat). Davies’s principalargument lay in results of the 2010 FASTT trial inwhich an accelerated protocol (three IUI cycles andimmediate IVF) was compared with a standardprotocol of clomiphene- and later FSH-stimulated IUIfollowed by IVF. The accelerated protocol wasassociated with a higher pregnancy rate (31% vs 98%and 7.6%), lower time to pregnancy, lower cost, andcomparable multiple rates.

Roy Homburg was more equivocal in designating theplace of IVF in unexplained infertility, noting thataround one-third of couples will conceive within threeyears without treatment (and 30% within a year).Treatment outcome, however, would depend uponprognosis, which is mainly determined by female ageand duration of infertility. Recent studies (see page 15,for example) had found no difference in live birth ratesbetween IVF and IUI, and there seemed no rationalefor a 2012 NICE recommendation from the UKadvising expectant treatment for up to two years andthen IVF. A more definitive answer to this still cloudyquestion may emerge from a RCT now in progress withHomburg’s own group - 280 couples randomised tothree cycles stimulated IUI or one cycle IVF.

And yet again, in debating the best treatment forwomen with diminished ovarian reserve, both speakers- Frank Broekmans from Utrecht and Marcelle Cedarsfrom San Francisco - were in considerable agreement.This time that no single stimulation protocol for IVFwould suit all cases, and that increasing FSH doses havelittle effect. Indeed, said Broekmans, ‘it’s all aboutfemale age . . . the cohort, not the FSH dose’ (or themany adjuvant treatments proposed).

Kutluk Oktay, formerly of Europe and now of NewYork Medical College, reported that some 40 babieshad so far been born following ovarian tissuetransplantation. Although not a new procedure, hedescribed it as ‘still evolving’ as a means of fertilitypreservation, particularly in view of new tissueharvesting and cryopreservation techniques. Oktaydescribed two strategies to improve ovarian transplantrevascularisation: the use of agents (such as S1P) toaccelerate the process, and enhanced surgicaltechniques, notably robotically assisted. The latter wasillustrated by remarkable footage of the robot

MENOPAUSE THERAPY ‘COMES FULL CIRCLE’Fertility specialists have little opportunity to meet the menopause(unless premature), but a presentation by former ASRM PresidentRoger Lobo brought home to this meeting the scale of the scandalbrought about by the Women’s Health Initiative (WHI) trial. Thiswas an RCT testing two menopausal hormone therapies (estrogenalone and estrogen + progestogen) against placebo. The trial,which cost an eye-watering $260 million at 2012 rates, was stoppedearly because of an increased risk of breast cancer (andcardiovascular disease) when reported in 2002. The effect wasdevastating, with most guidelines abandoning hormone therapy -and women to their symptoms. Since then, said Lobo, manystudies have found the WHI methodology flawed and its resultsinapplicable - and even a secondary analysis by the WHI itselffound that women who began therapy within the first ten yearsfollowing menopause actually reduced their risk of coronary heartdisease. With so many WHI conclusions reversed or constructivelydismantled over the past ten years, only now, said Lobo, ismenopause therapy for symptoms ‘coming full circle’ and returningto where it was before that first catastrophic WHI report.

procedure in action - and an announcement by Oktaythat the technique had already produced its firstpregnancy. ‘Now,’ said Oktay, ‘we have the chance todo a more delicate job.’

Another lecture at the cutting-edge of research camefrom Mary Herbert from the Newcastle, UK, centrenow likely to be the first in the world to begin clinicaltrials in mitochondrial donation and replacement.Following approvals in both houses of the UKparliament, Herbert said that the regulations are likelyto be in place before the year’s end, with clinicallicence applications shortly following. She explainedthat mutations in mitochondrial DNA affect energyproduction and thereby have serious consequences forthose organs which require a lot of energy (such as theheart or brain). Prevalence of mitochondrial disease isthought to be around one in 5000, with debilitatingand fatal consequences. In cases of high mutation load- in which other procedures such as PGD are notindicated - two nuclear DNA transfer techniques havebeen investigated in Newcastle, meiotic spindletransfer and pronuclear transfer. In each, said Herbert,there are two principal considerations: the onwarddevelopment of the embryo and the reduction inmutation load sufficient to prevent disease. Bothprinciples have been met in mouse models, and now,following public consultation and with legalconstraints removed, the work can progress to humanzygotes. More details can be found on page 17.

This year’s ‘Best of ’ programme, spread over threedays in New York, attracted a record 900+participants. The steering committee for the meetingannounced that the annual schedule will now beextended to every two years, with the next eventplanned for Europe in 2017.

Simon BrownFocus on Reprodcution


Following Helsinki in 2016, the venues for the Annual Meetings of2017 and 2018 have now been confirmed by ESHRE’s ExecutiveCommittee. The 2017 event will take place in Geneva, Switzerland,at the Centre International de Conference Geneve (CCIG), amodern convention centre located above the city and not far fromthe Palais des Nations of the WHO. This will be the second timethat an ESHRE Annual Meeting has been held in Switzerland -after Lausanne in 2001. In 2018 ESHRE will return to Barcelona, the fourth time an

Annual Meeting has been held in Spain (Barcelona 1988, Madrid2003, Barcelona 2008). Even though the city is no stranger toESHRE, the venue - the Centre de Convencions Internacional deBarcelona (CCIB) - will be a new departure. The centre, withcapacity for more than 15,000 participants, is located in theDiagonal Mar district overlooking the Mediterranean.


ESHRE NEWS

ESHRE’s data collection poised for online upgrade New online systems for EIM and PGD Consortiums ready for Lisbon launch

ESHRE’s two registries, the European IVF Monitoring(EIM) Consortium and PGD Consortium, are to introduceonline data collection this year. Both registries, whichstarted data collection in 1997, began with paper forms sentto ESHRE's Central Office for analysis. But now thatcumbersome system will come to an end.

The EIM Consortium has been in contact with severalcompanies familiar with data collection for nationalregistries. And one of them, Dynamic Solutions, a Spanishcompany, was asked to develop the EIM database. This wascompleted in 2014 and now the online version of thedatabase is set for introduction. The database will not onlybe more user friendly for participating countries, but willalso cut the time needed to analyse the data and compile the24 tables, which will all be generated automatically.

The database itself is now almost ready and the SteeringCommittee is completing final checks for the tables. Hopesare that the new database can be introduced in Lisbon -meaning that the next data collection, for 2013, can beperformed completely online.

The PGD Consortium was also in need of a new databaseand participated in the EIM discussions and developments.Dynamic Solutions was considered the most suitable for thePGD database, which needed a complete make-over. In thepast the Consortium had collected data first using Excel andlater File Maker Pro with four different modules (referral,cycle, pregnancy and baby). Thus, the PGD SteeringCommittee had to rethink its complete database before anynew development could start. However, Dynamic Solutionshas now delivered a first draft to the Steering Committee,and it is hoped that by the Annual Meeting in Lisbon thedatabase could be ready for its 60+ member centres to startproviding data prospectively.

For both data collections, a speedier process of analysing andreporting could give more time for more detailed and specificreports from the huge amount of data collected.

Veerle GoossensESHRE Science Manager

Venues for 2017 and 2018 agreed

PhD for ESHRE’s Science ManagerESHRE’s Science Manager Veerle Goossens hasbeen awarded her PhD from the VrijeUniversiteit Brussels (VUB). Her thesis -Preimplantation genetic diagnosis: from bench todata collection - was partly based on her workfor the ESHRE PGD Consortium in addressingthe importance of large-scale in-depthmulticentric data collection. Veerle’s promoterwas Professor Karen Sermon at the VUB, withco-promoters Professors Joep Geraedts andSjoerd Repping from the Netherlands.



ESHRE guideline on psychosocial care good to go Second ESHRE guideline developed according to established protocolA second ESHRE guideline developedaccording to the Society’s thoroughprotocol has now been completed. Theguideline, Routine psychosocial care ininfertility and medically assistedreproduction – A guide for fertility staff,was developed by a group chaired bySofia Gameiro, Deputy Co-ordinator ofthe SIG Psychology & Counselling, andincluding psychologists, agynaecologist, a midwife with a specialinterest in infertility, a patientrepresentative, and the ESHRE researchspecialist.

The guideline offers evidence-basedbest practice advice to all fertility clinicstaff on how to incorporatepsychosocial care into routine fertilitycare. Psychosocial care is defined ascare that enables couples, their families,and their health care providers tooptimise infertility care and manage thepsychological and social implications ofinfertility and its treatment.

By combining the best availableevidence, from literature searches andquality assessment, expert opinion andpatient input, 120 recommendationshave been formulated answering 12 keyquestions. All recommendations havebeen derived from consensus within thedevelopment group and were submittedto an extensive transparent review byrelevant stakeholders.

The guideline provides information intwo sections. In the first, information isgiven on the preferences of patientsabout the psychosocial care they receiveat clinics and how this care is associatedwith their well-being. In the secondsection, the psychosocial needs whichpatients experience before, during andafter treatment, and how staff candetect and address these needs, aredescribed.

Needs are defined as behavioural(lifestyle, exercise, nutrition andcompliance), relational (with partner,family, friends and larger network),emotional (anxiety, depression, quality oflife, well-being) and cognitive (treatmentconcerns and knowledge).

The guideline describes patient needs,risk factors for specific psychosocial

needs, and tools to detect them, and listsevidence-based psychosocialinterventions which can be delivered bymembers of staff without specialisttraining and which don’t require theactive intervention of mental healthprofessionals.

In addition to the recommendations,four main conclusions have been drawn. Patients have clear preferences aboutthe care they receive. Fertility staff shouldbe informed about these preferences andconsider implementing them. Fertility staff should be informed aboutthe specific needs patients experience atdifferent treatment stages and tailor theirpsychosocial care accordingly. Some patients are more vulnerable tothe demands of treatment and needadditional psychosocial care orspecialised mental-health services

(infertility counselling orpsychotherapy). Fertility staff shouldknow the risk factors for increasedpsychosocial needs. The most effective way to startimplementing psychosocial care is byproviding preparatory information,which is expected to be simple andfeasible to implement, and more effectivein addressing many patient needs(compared with other reviewedinterventions).

All recommendations can be found inthe full guideline which is now availableat the guideline section of the ESHREwebsite. A public version of the guidelineis in development, and a paper with themain messages will soon be published inHuman Reproduction.

Nathalie VermeulenESHRE Research Specialist

Extraordinary AGM extends Society objectivesAn extraordinary General Assembly of ESHRE members was held in Brussels on 27March to extend the statutory aims of the Society as set out in the by-laws.The extension - that ‘The Society can also acquire participations in whatever form,

in all existing or future legal entities and companies, under the condition that theselegal entities and companies have a closed/limited character and this happens withinthe framework of realizing the statutory goal of the society’ - would effectively givethe Society the authority, as allowed by the articles of association, to acquireparticipation in organisations considered commercial. This would extend the aims of the Society defined in the original by-laws as to

‘promote the study and treatment of reproductive biology and medicine'. This wasexplained in the original by-laws as ‘to promote improvements in the field of medicalpractice by organising training, education and advanced medical training activities,by setting up and keeping up databases and by applying methods that promote thesafety and quality of clinical and laboratory procedures’.The motion, which was carried unanimously (118 votes to zero) by the March

extraordinary General Assembly, will thus now extend (and not replace) the Society'sobjectives in accordance with the text. In explaining the background to the meeting and the extension of the Society’s

objectives, ESHRE Chairman Juha Tapanainen said that the question of aims andobjectives arose over discussions about a fourth ESHRE journal. It has long been amatter of concern to ESHRE’s ExCo that, with an ever decreasing acceptance rate forHuman Reproduction, more and more manuscripts submitted to the journal arebeing rejected. While Human Reproduction Update provides an appropriate title forreviews in reproductive medicine, and MHR for basic science, ESHRE has noalternative accommodation for original articles. The acquisition of a fourth titlewould provide that facility, but may require the purchase of a commercially runjournal. The by-law extension will now allow negotiation in such circumstances,although Tapanainen added that no such negotiations are presently taking place.



In response to a request forclarification, the European Court ofJustice has ruled that stem cells, celllines and tissues derived from theparthenogenetic activation of oocytes -parthenotes - cannot develop intohuman beings and are thus outside themeaning of ‘human embryo’ as definedby the Biotech Directive of 1998.1

However, in its judgment in the caseof Greenpeace vs Oliver Brustle in2011, the Court had ruled that theconcept of a ‘human embryo’ asdefined by the Biotech Directive didinclude human ova whose division andfurther development had beenstimulated by parthenogenesis. Suchcells, the Brustle judgement hadimplied, are comparable to embryoscreated by fertilisation and thus capableof development into a human being.2

Now, however, that judgement hasbeen challenged and the Court asked ifthe concept of ‘human embryo’ asinterpreted in the Brustle case is indeedlimited to organisms capable ofbeginning the process of developmentwhich leads to a human being.

And in response the High Court ofJustice has now recognised that,according to current scientificknowledge, parthenotes are not capableof developing into a human being andare thus not sufficient to be regarded asa ‘human embryo’.

Behind this latest challenge andsubsequent judgement lies the BiotechDirective of 1998 which, whilepromoting scientific innovation

through the patent system, also ruledthat the human body was notpatentable. Thus, the use of humanembryos for industrial or commercialpurposes was specifically listed as‘contrary to ordre public or morality'and were not patentable. This latestruling now appears to revise thoseformer restrictions and, in redefiningthe meaning of ‘human embryo’, toindicate that human parthenotes areindeed amenable to patent.

The implications in stem cell researchare likely to be considerable, openingthe door to work on cell lines derivedfrom parthenogenetically-activatedoocytes, which previously had appearedas proscribed as cell lines derived fromhuman embryos.

Rita Vassena, Scientific Director ofthe Clinica EUGIN in Barcelona andCo-ordinator of ESHRE’s SIG StemCells, explains that parthenotes havebeen used in research for the derivationof pluripotent stem cells forregenerative medicine.

‘Parthenogenetic stem cell lines dohave some immunological advantageover embryonic stem cells,’ she says,‘because of their monoparental origin.However, their relevance to clinicalpractice is still much debated, becauseof defects in the expression ofimprinted genes.

‘Nevertheless, parthenogenetic stemcell lines can be a very useful tool inbasic research, and this ruling will beuseful in countries where research on

human embryos is forbidden. Thenew ruling makes it clear thathuman parthenotes do not haveany potential for term developmentand should not, therefore, beconsidered as embryos.’

1. See press release 181/14.http://curia.europa.eu/jcms/upload/docs/application/pdf/2014-12/cp140181en.pdf2. See press release 112/11.http://curia.europa.eu/jcms/upload/docs/application/pdf/2011-10/cp110112en.pdf

EU Court of Justice concedes thatcells derived by parthenogenesis cannot be defined as ‘human embryos’

EUROPE NEWS

Artificial humanprimordial germ cellscreated from inducedpluripotent stem cells

Scientists from Israel and UK havereported the creation of humanprimordial germ cells, described as theprecursors of sperm and eggs, from iPScells in a procedure first applied in mice.1Now, they describe development of a‘robust approach’ to the specification ofhuman PGC-like cells, whose earliestmarker and ‘key regulator’ is thetranscription factor gene SOX17.

The first reports of artificial primordialgerm cells created from iPS cells came in2012 when biologists from KyotoUniversity developed a procedure inmice.2 Although these cells could notdevelop beyond this precursor stage in thedish, the Japanese researchers found thatthey would mature into functional oocyteand sperm cells if introduced to the testesand ovaries. The Kyoto group, includingiPS pioneers Shinya Yamanaka andMitinori Saitou, reviewed these advancesin Fertility and Sterility in 2012 andproposed strategies to develop in vitrodisease models of infertility using humanembryonic and iPS cells.3

Now, the latest human artificial cellshave been described as similar to humanprecursor germ cells - as the earlier cellswere to mice.

Reports suggest that, whiledevelopments in Japan are likely tocontinue functionality experiments inmice, there are no plans as yet to testfunction potential in humans and take thetechnology to the clinic. Manyjurisdictions - the USA, for example -would require a change of regulation forany federal funding.

1. Irie N, Weinberger L, Tang WWC, et al.SOX17 Is a critical specifier of humanprimordial germ cell fate. Cell 2015; 160: 253-268.2. Hayashi K, Ogushi S, Kurimoto K, et al.Offspring from oocytes derived from in vitroprimordial germ cell-like cells in mice. Science2012; 338: 971-975.3. Hayashi Y, Saitou M, Yamanaka S. Germlinedevelopment from human pluripotent stemcells toward disease modeling of infertility.Fertil Steril 2012; 97: 1250-1259.



Despite fears (and alarm) to thecontrary, the European Food SafetyAuthority has concluded that bisphenolA, a chemical used in the manufacture offood packaging materials and cancoatings, poses no health risk toconsumers of any age group.

The conclusion, delivered in January,comes after a re-evaluation of bisphenolA by the EFSA amid concerns that itmay have endocrine-disrupting effectson the reproductive and other systems.However, current exposures from diet orother sources, says the EFSA, are'considerably under the safe level'.

Although new data and refined testingmethodologies have led the EFSA toreduce the bisphenol A safety level from50 µg/kg per kg body weight per day to 4µg/kg, the highest estimates for dietaryexposure and for exposure from othersources (for example, through the skinfrom thermal cash register paper) arethree to five times lower than the newtolerable daily intake.

In the USA the FDA banned bisphenolA from baby bottles in 2012 butpresently maintains that levels currentlyused in food packaging are safe.

However, just months before the EFSAdelivered its verdict, specialists from theUniversity of Copenhagen reported

A substantial randomised trial in the Netherlands has foundthat IVF with single embryo transfer and modified natural cycleIVF were each non-inferior to stimulated IUI in terms of ahealthy live birth and low multiple pregnancy rates, in coupleswith unexplained infertility or mild male factor.1

The investigators - from 17 centres in the Netherlands - notethat stimulated IUI is still first-line treatment in cases ofunexplained or mild male factor infertility with a poor chanceof natural conception - but that there are concerns aboutincreased rates of multiple pregnancy with IUI. This three-armtrial was designed to test the two increasingly popular IVFprocedures against stimulated IUI.

More than 600 women were randomised to the three armsand results showed comparable live birth rates in all three (43-52%), with low rates of multiple pregnancy (5-7%).

Commenting on the results, the investigators propose that, inthe absence of a marked difference in pregnancy outcomes, ‘themore invasive’ IVF with SET and modified cycle IVF ‘may notbe desirable alternatives’ to stimulated IUI.

‘In view of these results,’ they add, ‘there seems no reason toabandon intrauterine insemination with controlled ovarianhyperstimulation as a first line treatment of couples withunexplained or mild male subfertility.’

1. Bensdorp A, Tjon-Kon-Fat RI, Bossuyt PMM, et al. Prevention ofmultiple pregnancies in couples with unexplained or mild malesubfertility: randomised controlled trial of in vitro fertilisation withsingle embryo transfer or in vitro fertilisation in modified natural cyclecompared with intrauterine insemination with controlled ovarianhyperstimulation. BMJ 2015; 350:g7771 doi: 10.1136/bmj.g7771.

IVF no better than stimulated IUI in unexplained and mild male infertility

detectable urinary levels of bisphenol Ain 98% of 308 young men examined.1Men with concentrations above thelowest quartile had higherconcentrations of serum testosterone,LH, estradiol, and free testosterone thanthose in the lowest quartile. Men in thehighest quartile also had significantlylower percentage progressive motilespermatozoa than men in the lowestquartile (–6.7 percentage points).However, bisphenol A was not associatedwith other semen parameters.Nevertheless, the investigators concludedthat, while the effects of bisphenol A inmale reproduction are ‘generally relatedto its estrogenic effect’, an effect on thehypothalamic–pituitary–gonadalhormone feedback system may be afurther mode of action.

A more recent US study in mice is thefirst to suggest that even low exposuresto bisphenol A early in life (or otherestrogen contaminants) can alter thestem cells responsible for producingsperm later in life.2 Exposure, said theprincipal investigator, ‘is not simplyaffecting sperm being produced now, butimpacting the stem cell population, andthat will affect sperm producedthroughout the lifetime’.

It was such fears - built on a huge

Bisphenol A: ‘no health risk’ in male reproduction European Food Safety Authority re-evaluation Studies continue to show association with sperm quality

catalogue of studies on the toxic effectsof bisphenol A - which no doubtprompted the French authorities inJanuary (just weeks before the EFSAannouncement) to ban the use ofbisphenol A in food packaging. SégolèneRoyal, recently appointed environmentminister, denounced bisphenol A as adanger to human health.

Declining sperm counts have been asubject of concern and conjecture sincethe early 1990s, when the sameUniversity of Copenhagen group ascited above reported ‘a genuine declinein semen quality over the past 50 years’.

1. Lassen TH, Frederiksen H, Jensen TK, etal. Urinary bisphenol A levels in young men:Association with reproductive hormones andsemen quality. Environ Health Perspect 2014;122: 478–484. 2. Vrooman LA, Oatley JM, Griswold JE, etal. Estrogenic exposure alters thespermatogonial stem cells in the developingtestis, permanently reducing crossover levelsin the adult. PLoS Genet 2015; 11: e1004949.doi: 10.1371/journal.



EUROPE NEWS

The last two decades have seen a steadyimprovement in the health of childrenborn after ART, with fewer preterm andstill births, low birth weights, andperinatal deaths.

These encouraging findings comefrom the CoNARTaS study, the largeststudy to date to investigate the health ofART babies over time; data from morethan 92,000 children in Denmark,Finland, Norway and Sweden wereanalysed for this population study, whichwas published in Human Reproductionearlier this year.1

Dr Anna-Karina Henningsen, from theRigshospitalet in Copenhagen, and herNordic colleagues analysed the outcomesof 62,379 singleton and 29,758 twinbirths between 1988 and 2007 in thefour Nordic countries. They comparedthem with control groups of 362,215spontaneously conceived singletons and122,763 spontaneously conceived twinsborn in the same countries in the sameperiod.

There was a ‘remarkable’ decline in therisk of being born preterm and verypreterm among the singletons conceivedafter ART. The proportion of ARTsingletons born with a low and very lowbirthweight also decreased, while thestillbirth and infant death rates declinedamong both ART singletons and twins.

‘These data show,’ said Dr Henningsen,‘that if there is a national policy totransfer only one embryo per cycleduring assisted reproduction, this notonly lowers the rates of multiplepregnancies, but also has an importanteffect on the health of the single baby.’

Dr Henningsen added that otherfactors had also contributed to theimprovement in the health of ARTbabies over the past 20 years - whichincluded technical skills in thelaboratory, clinical skills of the doctors,and milder ovarian stimulation.

She concluded: ‘These findings showconvincingly that, while there has been aconsiderable increase in assistedreproduction cycles over the past 20

SET mainly explains ‘significant improvements’in ART baby health over the past 20 years Findings from the world’s largest study of ART baby health over time

Germany's Federal Court of Justice shocked many clinics in January by declaringthat children conceived by ‘anonymous’ sperm donation have the right to knowthe identity of their biological father, whatever the age of the child. The Courtruled that a minimum age was not necessary for disclosing donor identity andthat the rights of the child were greater than those of the donor.Thus far, sperm donation in Germany had been anonymous, although the donor

clinic had a responsibility to ask and retain identifying information from thedonor. Those identities could only be disclosed with permission of the donor. Butnow, Germany joins a growing number of EU countries - such as Finland, Swedenand UK - in only allowing non-anonymous sperm donation. (Oocyte donationremains outlawed in Germany.)The new decision came after two sisters, 12 and 17 years old, appealed to the

Federal Court of Justice after a Karlsruhe clinic refused to provide their father'sidentity. The girls' legal parents had already signed a document saying theyaccepted the anonymity of the donor.However, as the children grew older, the parents, acting as the girls' legal

representatives, changed their views and appealed to the state court in Hannoverfor disclosure permission. The court rejected the appeal, after which the girls tooktheir case to the Federal Court of Justice.The federal judges did attach conditions, notably that all parents requesting

donor identity must be able to prove that the child has requested the information,and that possible effects on the private life of the donor must be taken intoaccount.According to press reports, the number of people in Germany fathered by

sperm donations is estimated to be around 100,000. Up to 5000 children are saidto be conceived annually with donor sperm.

years, this has been accompanied by asignificant improvement in healthoutcomes for these babies, particularlyfor singleton babies. The most importantreason is the dramatic decline inmultiple births due to policies ofchoosing to transfer only one embryo ata time.’

The study was partly funded byESHRE, going back to 2007 whenAnders Nyboe Andersen and KarlNygren, pioneers of ESHRE’s EIMConsortium, sought funding to create anART database from the four Nordiccountries to monitor safety. This led tothe CoNARTaS (Committee on NordicART and Safety) collaboration, which

was initially funded in part by ESHREand largely driven by Dr Henningsenand Anja Pinborg. The collaboration isnow being funded by various sources -including NordForsk (Norwegian PublicFunding Institution) - and has publishedseveral papers.

A new study track is currently underway, adding a further 50,000 infantsborn after 2007 to the dataset.

1. Henningsen AA, Gissler M, Skjaerven R, etal. Trends in perinatal health after assistedreproduction: a Nordic study from theCoNARTaS group. Hum Reprod 2015;doi:10.1093/humrep/deu345.

German court gives DI children the right to know their donor’s identity



Legislation to allow clinical trials of mitochondrial donation in couplesknown to be at high risk of passing on mitochondrial diseases to theirchildren have been approved in the UK. The move follows votes in theUK’s lower and upper Parliaments (the House of Commons and Houseof Lords) and means that the first trials could begin towards the end ofthis year. The trials are likely to be at the Wellcome Trust Centre forMitochondrial Research at Newcastle University, under the directionof Professor Doug Turnbull, which would need to apply for a researchlicense from the HFEA, the UK’s regulatory authority. Professor MaryHerbert from the Newcastle group will review the techniques ofmitochondrial donation and replacement during the main programmeof ESHRE’s Annual Meeting in Lisbon.

The possibilities of preventing the transmission of mitochondrialdiseases (which are said to affect around 2500 women in Britain) waspreviously the subject of a favourable public consultation by theHFEA.

Two techniques have been explored so far: nuclear transfer from theintended parents' affected zygote to an enucleated donor zygote withhealthy mitochondria; and maternal meiotic spindle transfer in whichthe meiotic spindle from the mother's affected oocyte is transferred toa healthy donor oocyte (whose spindle has been removed) beforefertilisation with the partner’s sperm. Speaking at the ‘Best Of ’meeting in New York in March, Professor Herbert said that her grouphad concentrated on pronuclear transfer. Both techniques, however,involve genetically modifying a human oocyte, which has not beenpermitted in any treatment in the UK.

The controversial issue, however, as demonstrated in theconsultations and Parliamentary debates, is not the technique, but theethics of gene modification - and the inevitably that in each of thesetechniques the healthy reconstructed zygote will contain the donor'smitochondria as well as the intended parents’ own DNA. It was for thisreason that the ever inventive British press dubbed the technique‘three-parent IVF’ and rightly raised the question of future geneticinheritance in these families - even though the proportion of donormitochondrial DNA in these embryos would be very small (around0.2% of the total genetic material).

While ESHRE has made no formal statement on mitochondrialdonation (or any contribution to the consultations), Anna Veiga,ESHRE's former Chairman, said: ‘The minor contribution from thedonor’s mitochondria to the genetic constitution is not expected tocause any unexpected adverse outcome in the offspring. In myopinion, no major ethical concern arises in such cases, consideringthat oocyte donation is a frequently used alternative in affectedcouples. As in any other ART procedure, couples must receivecomplete and detailed information.’

Members of both Houses were subject to intense lobbying before thevotes. Protests came from the Church of England and, in a letter toThe Times newspaper, from 55 Italian MPs.

Legislation for mitochondrial donation approved in UK Move follows public consultation Questions over ethics of gene modification

Two techniques have been proposed: pronucleartransfer and meiotic spindle transfer.

HFE

A



IN PROFILE

Richard Sharpe,Deputy Editor ofHumanReproduction,talks about thejournal’s statusand ambitions -and his ownresearch in malereproduction.

WORLD NEWS

Preliminary data reported in Munich last year fromESHRE’s EIM Consortium suggested that thepreference for ICSI over IVF is at last declining. Yet nosuch patterns seem yet to be evident in the USA.

An analysis of all US ART data submitted to theCDC shows that ICSI use increased from 36.4% in1996 to 76.2% in 2012, with the largest relative increaseamong cycles without male factor infertility.1Compared with conventional IVF, ICSI use was notassociated with any improved outcomes post-fertilisation in the absence of a male factor infertilitydiagnosis.

The retrospective study was performed by the CDC'sNational Assisted Reproductive TechnologySurveillance System (NASS), a data reporting systemfor the federally mandated collection of all ART cyclesperformed in the USA, and reviewed more than 1.3million fresh cycles from 1996. High ICSI use provedno surprise in male factor cycles, but its use reached aprevalence rate of 67% in non-male factor treatments.

In these non-male factor cycles outcome analysisshowed that ICSI was associated with a lower multiplebirth rate than conventional IVF (30.9% vs 34.2%),lower implantation rate (23.0% vs 25.2%), and lowerlive birth rate (36.5% vs 39.2%).

Markus Kupka, presenting preliminary EIM data for2011 last year in Munich, reported a similar overallrate of ICSI use in Europe of around 67%, but withlittle change over the past three years. There was,however, huge variability in the trends, with low utilitycountries - such as Denmark and Sweden - using ICSIin 40-50% of cycles, and high utility countries - such asPoland, Montenegro, Greece, Spain and Switzerland -in more than 80% of cycles.

Commenting on the NASS report, Kupka said: ‘Itwould be interesting to see the US data presented stateby state. This would no doubt demonstrate that the

state differences are similar in variability to those ofEuropean countries.’

The CDC report on ICSI was the second sub-analysis from the NASS, after an earlier review of ARTsafety data between 2000 and 2011.2 This study, said tobe ‘the first, to our knowledge, to quantify US ART-associated patient risks’, found OHSS the mostcommon adverse event, at a rate of 153 per 10,000autologous cycles, with no other significant trendsdetected.

1. Boulet SL, Mehta A, Kissin DM, et al. Trends in use of andreproductive outcomes associated with intracytoplasmic sperm injection. JAMA 2015; 313: 255-263. 2. Kawwass JF, Kissin DM, Kulkarni AD, et al. Safety ofassisted reproductive technology in the United States, 2000-2011. JAMA 2015; 313: 88-90.

Latest CDC data on the numbers of ICSI procedures performed in the USAaccording to type of ART cycle, 2003–2012

UK study aims to track the lifetime development of 80,000 babies

ICSI use still growing in USA in new CDC review

A study to track the growth,development, health and well-being ofover 80,000 babies and their parents hasbeen announced in Britain. The LifeStudy, say the organisers, will provideinformation on the lives of a newgeneration of babies growing up withglobal warming and a whole new rangeof non-communicable diseases.1

The UK study thus hopes to succeedwhere other similar longitudinal birthcohort studies have failed, notably theNational Children’s Study in the USAwhich aimed to follow 100,000 children

from birth to age 21 but was cancelled inDecember last year before launch, and15 years and $1.2 billion later.2

According to Nature, studies inNorway and Denmark are also followingmore than 100,000 children, and the UKitself has already had a series of smallerbirth cohorts, the first of which startedin 1946. But the Life Study aims to setitself apart by collecting detailedinformation on pregnancy and the firstyear of the children’s lives, a period thatis considered crucial in shaping laterdevelopment.

The Life Study, which will be hosted byUniversity College London and run byProfessor Carol Dezateux, will invitewomen and their partners to take partduring pregnancy or soon after birth,and they and their new baby will be seenat specially commissioned Life Studycentres on three occasions duringpregnancy and the first year of the baby’slife, or in their own homes during thebaby’s first year.

1. http://www.lifestudy.ac.uk/homepage.2. http://www.nature.com/news/nih-ends-longitudinal-children-s-study-1.16556.



IN PROFILE

oR: You've been Deputy Editor of HumanReproduction since 2012. What does the jobinvolve?RS: Mainly dealing with problem manuscriptsand unsolicited manuscripts, case reports,opinions . . . and deciding which of these non-routine manuscripts should be sent out forreview. The two Deputy Editors deal with allthese papers, plus any appeals by authors andother problems . . . fraud, plagiarism. In thesecases, I and the other Deputy Editor andEditor-in-Chief discuss the best course ofaction.

These are the problems with editing ajournal, but overall, how do you see HumanReproduction right now? It seems to be asteady, well respected publication.There’s a wish by the Editor-in-Chief - withwhich I agree - to improve its impact, to tryand be more selective in the manuscriptspublished. This means that we’re trying toremove a lot of the more routine papers fromthe huge number we receive, so that we canfocus on material which is likely to be highlycited - and which may help raise the profileof the journal and research in reproduction.

How do you form an impression of what islikely to be well cited? And are citationsyour only motivation?I’d say that citability is our primarymotivation. We can’t publish everything.That’s the bottom line, so we have to decidewhat our main goal is. And our goal is to bethe top journal in reproductive medicineand science, one which only publishesexcellent papers and sets the standardthroughout the world. And how do we goabout that? It’s by simply selecting the bestpapers and by weeding out the rest. There’soften nothing wrong with them scientifically- they can go through the peer reviewprocess and be perfectly OK, but they areoften what I might describe as just anotherbrick in the wall - as opposed to acompletely new wall. Ideally, of course, wedon’t want to go through the whole reviewprocess and then say no. So we need toensure that the Associate Editors andeveryone else making decisions can triagethese manuscripts, to identify them at thesubmission stage and say, we don’t think thisone will make it.

Some have said that Human Reproductionputs too great an emphasis on randomisedtrials and high-grade evidence.

In pursuit of the evidencein the journal and the lab

Richard Sharpe,Deputy Editor ofHumanReproduction,talks about thejournal’s statusand ambitions -and his ownresearch in malereproduction.

‘In the areas the journal covers there are a lot ofdevelopments which are not evidence-based.’

Latest CDC data on the numbers of ICSI procedures performed in the USAaccording to type of ART cycle, 2003–2012



It’s true that the changing incidence oftesticular germ cell cancer has been dramaticin Western countries. It’s certainly nothing todo with altered diagnosis or living longer,because it’s a disease of young men. And it’s adisease which has its origins in fetal life but ismanifest in young adulthood. So it hasbecome in many respects an archetypal malereproductive disorder.

So what’s the consensus explanation for thedramatic rise in incidence?That’s the $64,000 question. Clearly, it issomething to do with our environment andlifestyle. It’s not genetic, because the incidencerose so rapidly. But what? The critical periodseems to be 8-12 weeks gestation, so there’spotential for the mother’s diet, lifestyle,chemical exposures and occupation to get tothe fetus and exert an effect.

So is this mechanism only acting throughthe mother?Yes, but we’ve yet to understand theepigenetic effects. This will be the next bigissue. There’s certainly growing evidence inmale reproductive health for exposures thatcan induce epigenetic effects - the diet yourgrandfather had is one good example.

Do you think that’s likely to emerge withgreater strength as a hypothesis?I think so. There’s already evidence inhumans, and certainly in animal studies, thatthis can happen, but we’ve no idea of the scaleof such effects in humans.

But getting back to the basics of this, you dobelieve that there has been a genuinedecline in sperm concentrations?I think that where we have good evidencewithin a country - where we have measuresdetermined by similar methodology todayand 50 years ago - yes, I think sperm counts

Edinburgh has become one ofthe world’s leading centres forunderstanding the fetalprogramming of adult disease.In the male, disorders manifestat birth such as hypospadiasand cryptorchidism, or inyoung adulthood such as lowsperm counts, testicular germcell cancer and reducedtestosterone levels, arecommon and/or increasing inincidence. Sharpe hasconsistently argued thatlifestyle and/or environmentalfactors must be responsible forthis increase. The aim of hisresearch is to establish thepathways that govern normaltestis development andfunction (pictured left) in fetallife which are vulnerable todisruption.

‘It’s only in the last 20 years thatwe’ve learnt that the early fetal

period is by far the mostimportant for determining your

overall reproductive health.’

Well, that’s a policy I would subscribe to. Inthe areas the journal covers there’s a lot ofactivity, a lot of developments, which are notevidence-based. Just people trying things out,often on patients. There are various ways inwhich people can say that that’s OK, but formost of us it is scientifically indefensible. Weneed solid evidence, and we should always tryto make decisions based on evidence.

So citability and the strength of evidence isa far greater consideration than a talkingpoint over coffee?Of course. We’re not gong for sensation inHuman Reproduction, unless that sensation isunderpinned by real, strong evidence.

So with that in mind how do you see thenext few years of the journal? More of thesame? Do you think growth in terms ofimpact factor has got as far as it can go?It depends. We’ve set out a game plan wherewe want to improve the impact factor andimprove the overall quality of the journal.And we need a five-year plan to do that. It’sonly when you get to the end of that five

years that you’ll know how successful youhave been, and whether or not you need torethink. What we anticipate will happen isthat, as we decline more and more routinemanuscripts, authors will recognise this andnot submit them. This could mean that wewill have fewer manuscripts submitted. But ifas planned the impact factor continues to goup, it might also mean that we get more andmore manuscripts, as authors increasinglyhope to get their work published in a highimpact factor journal.

Would increased frequency of HumanReproduction help absorb those extramanuscripts?Rejected manuscripts are an ongoing matterof discussion. Certainly, if we put amanuscript through the review process and itcomes out as OK but just not quite goodenough to be published in HR, then what dowe do with it? Could we divert theseborderline papers to another journal? Butthat’s the only consideration underdiscussion. The idea of publishing morefrequently hasn’t come up.

You’re here working in Edinburgh, wherethere’s a huge tradition in the science ofreproduction.I came her 35 years ago to join what was thenthe reproductive biology unit. My interest wasin a certain aspect of male reproductivefunction, and that interest has reallyexpanded since then. It’s changed shape alittle, but it’s become much more embracingof male reproductive disorders - their originsand their causes. Now the focus is very muchthe prenatal origin of reproductive disorders.And I think that was largely triggered by thefalling sperm counts issue in the early 1990s.This led us to the realisation that theimportant determinants of sperm counts -indeed all aspects of male reproductivefunction - are set up early in fetal life. Andthat poses a huge problem for human studies- because we can’t directly study it. We can’tintervene. So a lot of this work has had tofocus on developing and validating animalmodels, to give us the information that wecould then take into the human.

So after 35 years how much further downthe road are you? What more do we knowabout these conditions?What we didn’t know back then was theinfluence of different periods of life. So if youhave a male reproductive disorder, does itarise in puberty, or in adulthood, or does ithave earlier origins. It’s only in the last 20years that we’ve learnt that the early fetalperiod is by far the most important fordetermining your overall reproductive health.That’s because there is a critical period - themasculinisation programming window - inwhich you have to have enough androgenexposure to programme the laterdevelopment of your reproductive system.

So given the importance of this early phase,how important are the effects of lifestyleand environment? Hasn’t there been asuspicion that environmental effects have arole in testicular cancer and hypospadias?



It’s true that the changing incidence oftesticular germ cell cancer has been dramaticin Western countries. It’s certainly nothing todo with altered diagnosis or living longer,because it’s a disease of young men. And it’s adisease which has its origins in fetal life but ismanifest in young adulthood. So it hasbecome in many respects an archetypal malereproductive disorder.

So what’s the consensus explanation for thedramatic rise in incidence?That’s the $64,000 question. Clearly, it issomething to do with our environment andlifestyle. It’s not genetic, because the incidencerose so rapidly. But what? The critical periodseems to be 8-12 weeks gestation, so there’spotential for the mother’s diet, lifestyle,chemical exposures and occupation to get tothe fetus and exert an effect.

So is this mechanism only acting throughthe mother?Yes, but we’ve yet to understand theepigenetic effects. This will be the next bigissue. There’s certainly growing evidence inmale reproductive health for exposures thatcan induce epigenetic effects - the diet yourgrandfather had is one good example.

Do you think that’s likely to emerge withgreater strength as a hypothesis?I think so. There’s already evidence inhumans, and certainly in animal studies, thatthis can happen, but we’ve no idea of the scaleof such effects in humans.

But getting back to the basics of this, you dobelieve that there has been a genuinedecline in sperm concentrations?I think that where we have good evidencewithin a country - where we have measuresdetermined by similar methodology todayand 50 years ago - yes, I think sperm counts

have fallen. But whether that’s true in everycountry, we just dont have enough evidence.

You have described human fertility as on ‘arocky road’ to the future. Do you see anoverall decline in fertility?I think that’s almost beyond debate. But weshouldn’t be too worried about the past, weshould be focused on young men now. Weknow that average sperm counts in youngmen today, at least across Northern Europe,are at a level at which they begin to impact acouple’s fertility. They’re at a level that willaffect the time it takes to get your partnerpregnant- it will take longer than if you had asperm count which was twice as high. And it’sin that context that you then have to factor inthe fact that women are postponing their firstchildren to 30 and beyond, at which pointthey too are on a downward fertility decline.If you put that change together with a manwith a low sperm count, there’s only oneconclusion to be drawn, and that’s increasingfertility problems.

Does it matter?Yes, of course. It matters to the couples, andto populations across Europe. All EUcountries are below population replacementlevel for births. There’s no magic solution.IVF is not the answer, because IVF outcomesalso get worse with female age.

Is it any coincidence that your work -research and editing a journal inreproduction - is taking place in Edinburgh.There’s a huge tradition here, going back toRobert Edwards, even Dolly the sheep.Edinburgh has always been one of the topcentres in the world in reproduction. ButEdinburgh is also one of the leading centresfor understanding fetal programming of adultdisease. You could say that the mostimportant determinants of health happen inthe womb - most important because oncethey’ve happened, there’s very little you cando to change it. It may be possible, but wecertainly don’t know how to do it now. Andthat’s a big challenge for us in Edinburgh.

PROUST QUESTIONNAIRE* Which trait do you dislike in others?Any mix of selfishness, arrogance anddisregard for others

And in yourself?Do you want a list? I am too unemotional

What is your greatest fear?There are a few, but the greatest would be tobecome physically (or mentally)incapacitated

Who do you most admire?My wife – for putting up with me and mywork

What do you consider your greatestachievement?Helping my wife bring up four kids

If not Scotland, where would you mostlike to live?Any part of the West Country of England,where I’m originally from

A talent you would most like to have?To be a great thriller writer who can createreal believable people simply out of words

What is your favorite occupation?Research scientist! Or as I describe it toschoolchildren, an explorer

And your favorite writer?Michael Connelly. I lovecrime fiction as an escape

What was the last book you read?The Silkworm by JK

Rowling under her aliasRobert Galbraith.Another brilliantstoryteller.

And the lastvacation?The Canary Islands – in November

Your greatest extravagance?I don’t really do anything extravagant,although two years ago I did spend nearly£30,000 on a decent car!

* A personal questionnaire celebrated andoriginally made popular by the French writerMarcel Proust

Since the early 1990s and the firstreports of a ‘genuine’ decline in spermconcentrations over the previous 50

years, Sharpe’s research has focused onthe determinants of reproductive

disorders in men.



Country How regulated ET limit? Allowed? State funding? Public clinics Private clinics Cycles/yr % reimbursed . . . with eligibility criteria? Are the following reimbursed?PGD PGS Embryo freezing Gamete donation Surrogacy Medication FET IUI Cryo PGS Time-lapse Blastocyst culture

Austria Legislation Yes1 Yes Not yet Yes Yes, non-anonymous No Yes 8 23 ~8000 ~80%, age, indication, no. cycles Y N N Y N N Y

Belgium Legislation Yes2 Yes Yes Yes Yes, anonymous and non Yes Yes 34 in total ~21,000 ~90%, female age, max 6 cycles Y Y Y Y Y (but not biopsy) N Y

Bulgaria Legisaltion Yes3 Yes Yes Yes Yes, anonymous No Yes 3 32 ~8500 ~35%, resident, female age, indication Y N N Y N N N

Croatia Legisaltion Yes4 Yes Yes Yes Yes, non-anonymous No Yes 7 5 ~5000 ~80%, female age (42 yrs) Y Y Y Y N N Y

Cyprus Legislation + guidelines Yes Yes Yes Yes Yes, anonymous and non Yes Yes 0 5 ~2000 ~50%, female age (40 yrs) Y Y N N N N N

Estonia Legislation Yes5 Yes Yes Yes Yes, anonymous5 No Yes 3 2 ~1900 ~90%, health insurance, F age (41 yrs) Y Y N Y N N Y

Finland Legislation No Yes Yes Yes Yes, non-anonymous No Yes 10 14 ~10,000 ~90%, indication, female age Y Y Y N N6 N Y

France Legislation + guidelines Yes7 No No Yes Yes, anonymous No Yes 50 50 ~60,000 100%, female age (45 yrs) Y Y Y Y N N N

Georgia None No 0 15 ~1000 0%

Germany Legislation + guidelines Yes8 Yes Yes8 Yes8 Non-anonymous sperm only No Yes 30 100 ~55,000 ~65%, F age (25-40 yrs), married Y (50%) N Y (50%) N N N N

Greece Legislation + guidelines Yes9 Yes Yes Yes Yes, anonymous Yes Yes9 9 43 ~90%, married, state insured, max 3 cycles Y N Y N N N N

Hungary Legisaltion + guidelines Yes10 Yes No Yes Yes, anonymous No Yes 3 9 ~7000 ~85%, female age (45 yrs), indication Y Y Y Y N N N

Ireland Guidelines No Yes11 No11 0 7 ~2000 0% Y in part N N N N N N

Italy Legislation + guidelines No Yes Yes Yes Yes, anonymous No Yes 63 9512 ~56.000 ~65%, female age, previous attempts Y Y Y N N N N

Lithuania No specific ART regulation Yes13 No No13 Yes No No No 0 5 ~700 0%

Macedonia Legislation Yes14 Yes Yes Yes Yes, anonymous and non Yes Yes 1 9 ~2000 ~50%, indication Y N N N N N Y

Netherlands Legisaltion + guidelines Yes15 Yes15 Yes Yes Yes, non-anonymous Yes Yes 13 0 ~17,000 ~80%, ETs, female age, previous cycles Y Y Y Y N N N

Norway Legislation No Yes No Yes Non-anonymous sperm only No Yes 6 5 ~6300 ~70%, 3 cycles max, only public centres Y Y Y Y Y Y

Poland Guidelines16 Yes16 Yes Yes Yes Yes, anonymous Yes 4 37 ~15,000 ~70%, indication, duration infertility, age Y Y Y Y N N Y

Portugal Legislation Yes17 Yes Yes Yes Yes, anonymous No Yes 11 16 ~5000 ~50%, heterosexual couples, F age (40 yrs) Y Y Y Y N N Y

Romania Legislation + guidelines18 No Yes Yes Yes Yes, anonymous and non Yes No18 2 20 ~2000 ~30%, residency, insured, F age (40 yrs), BMI N N N N N N N

Serbia Legislation Yes19 Yes Yes Yes Yes, anonymous No Yes 5 12 ~4000 ~30%, F age (40 yrs), BMI, FSH19 Y Y Y N N N Y

Slovakia Legislation No Yes Yes Yes Yes, anonymous No Yes 1 8 2150 ~80% Y N N N N N N

Slovenia Legislation + guidelines Yes20 Yes Yes Yes Yes, anonymous No Yes 3 0 ~4000 ~90%, indication Y Y Y Y Y Y Y

Spain Legislation + guidelines Yes21 Yes Yes Yes Yes, anonymous No Yes 41 197 ~80,00021 ~25%, F age, children Y Y Y Y Y Y Y

Sweden Legislation + guidelines Yes22 Yes No22 Yes Yes, non-anonymous No Yes22 6 10 12,500 ~60%, F age (40 yrs), no previous children Y Y Y Y N Y Y

Switzerland Legislation + guidelines Yes23 No No No Sperm only No No 7 22 ~5600 0% N N Y N N N N

Turkey Legislation + guidelines Yes24 Yes Yes Yes No No Yes 25 135 ~35,000 ~20%, indication, F age (40 yrs), insurance Y Y Y Y N N Y

UK Legislation + guidelines Yes25 Yes Yes Yes Yes, non-anonymous25 Yes Yes 78 in total ~65,000 ~40%, indication, F age (39 yrs) Y Y Y Y N N Y

ART regulation and reimbursement in Europe

The most common questions received from journalists by ESHRE’scommunications manager relate to regulations in different Europeancountries. It was to provide Christine Bauquis with a reference of up-to-date information that we asked members of ESHRE’s Committee ofNational Representatives to summarise their local arrangements.

The result - in answers to a simple questionnaire - was completed byalmost all country representatives and now provides a unique snapshot

of how ART is organised and run throughout Europe.ESHRE itself has conducted such surveys before, but not with the

same blanket coverage, nor in such detail, and we are very grateful tothe CNR for their co-operation. A summary of the results is presentedin table form below. In all cases we have had to summarise theinformation provided by each country into note form (for reasons ofspace), so we hope our interpretation is accurate and a fair reflection of

COMMITTEE OF NATIONAL REPRESENTATIVES



Country How regulated ET limit? Allowed? State funding? Public clinics Private clinics Cycles/yr % reimbursed . . . with eligibility criteria? Are the following reimbursed?PGD PGS Embryo freezing Gamete donation Surrogacy Medication FET IUI Cryo PGS Time-lapse Blastocyst culture

Austria Legislation Yes1 Yes Not yet Yes Yes, non-anonymous No Yes 8 23 ~8000 ~80%, age, indication, no. cycles Y N N Y N N Y

Belgium Legislation Yes2 Yes Yes Yes Yes, anonymous and non Yes Yes 34 in total ~21,000 ~90%, female age, max 6 cycles Y Y Y Y Y (but not biopsy) N Y

Bulgaria Legisaltion Yes3 Yes Yes Yes Yes, anonymous No Yes 3 32 ~8500 ~35%, resident, female age, indication Y N N Y N N N

Croatia Legisaltion Yes4 Yes Yes Yes Yes, non-anonymous No Yes 7 5 ~5000 ~80%, female age (42 yrs) Y Y Y Y N N Y

Cyprus Legislation + guidelines Yes Yes Yes Yes Yes, anonymous and non Yes Yes 0 5 ~2000 ~50%, female age (40 yrs) Y Y N N N N N

Estonia Legislation Yes5 Yes Yes Yes Yes, anonymous5 No Yes 3 2 ~1900 ~90%, health insurance, F age (41 yrs) Y Y N Y N N Y

Finland Legislation No Yes Yes Yes Yes, non-anonymous No Yes 10 14 ~10,000 ~90%, indication, female age Y Y Y N N6 N Y

France Legislation + guidelines Yes7 No No Yes Yes, anonymous No Yes 50 50 ~60,000 100%, female age (45 yrs) Y Y Y Y N N N

Georgia None No 0 15 ~1000 0%

Germany Legislation + guidelines Yes8 Yes Yes8 Yes8 Non-anonymous sperm only No Yes 30 100 ~55,000 ~65%, F age (25-40 yrs), married Y (50%) N Y (50%) N N N N

Greece Legislation + guidelines Yes9 Yes Yes Yes Yes, anonymous Yes Yes9 9 43 ~90%, married, state insured, max 3 cycles Y N Y N N N N

Hungary Legisaltion + guidelines Yes10 Yes No Yes Yes, anonymous No Yes 3 9 ~7000 ~85%, female age (45 yrs), indication Y Y Y Y N N N

Ireland Guidelines No Yes11 No11 0 7 ~2000 0% Y in part N N N N N N

Italy Legislation + guidelines No Yes Yes Yes Yes, anonymous No Yes 63 9512 ~56.000 ~65%, female age, previous attempts Y Y Y N N N N

Lithuania No specific ART regulation Yes13 No No13 Yes No No No 0 5 ~700 0%

Macedonia Legislation Yes14 Yes Yes Yes Yes, anonymous and non Yes Yes 1 9 ~2000 ~50%, indication Y N N N N N Y

Netherlands Legisaltion + guidelines Yes15 Yes15 Yes Yes Yes, non-anonymous Yes Yes 13 0 ~17,000 ~80%, ETs, female age, previous cycles Y Y Y Y N N N

Norway Legislation No Yes No Yes Non-anonymous sperm only No Yes 6 5 ~6300 ~70%, 3 cycles max, only public centres Y Y Y Y Y Y

Poland Guidelines16 Yes16 Yes Yes Yes Yes, anonymous Yes 4 37 ~15,000 ~70%, indication, duration infertility, age Y Y Y Y N N Y

Portugal Legislation Yes17 Yes Yes Yes Yes, anonymous No Yes 11 16 ~5000 ~50%, heterosexual couples, F age (40 yrs) Y Y Y Y N N Y

Romania Legislation + guidelines18 No Yes Yes Yes Yes, anonymous and non Yes No18 2 20 ~2000 ~30%, residency, insured, F age (40 yrs), BMI N N N N N N N

Serbia Legislation Yes19 Yes Yes Yes Yes, anonymous No Yes 5 12 ~4000 ~30%, F age (40 yrs), BMI, FSH19 Y Y Y N N N Y

Slovakia Legislation No Yes Yes Yes Yes, anonymous No Yes 1 8 2150 ~80% Y N N N N N N

Slovenia Legislation + guidelines Yes20 Yes Yes Yes Yes, anonymous No Yes 3 0 ~4000 ~90%, indication Y Y Y Y Y Y Y

Spain Legislation + guidelines Yes21 Yes Yes Yes Yes, anonymous No Yes 41 197 ~80,00021 ~25%, F age, children Y Y Y Y Y Y Y

Sweden Legislation + guidelines Yes22 Yes No22 Yes Yes, non-anonymous No Yes22 6 10 12,500 ~60%, F age (40 yrs), no previous children Y Y Y Y N Y Y

Switzerland Legislation + guidelines Yes23 No No No Sperm only No No 7 22 ~5600 0% N N Y N N N N

Turkey Legislation + guidelines Yes24 Yes Yes Yes No No Yes 25 135 ~35,000 ~20%, indication, F age (40 yrs), insurance Y Y Y Y N N Y

UK Legislation + guidelines Yes25 Yes Yes Yes Yes, non-anonymous25 Yes Yes 78 in total ~65,000 ~40%, indication, F age (39 yrs) Y Y Y Y N N Y

The most common questions received from journalists by ESHRE’scommunications manager relate to regulations in different Europeancountries. It was to provide Christine Bauquis with a reference of up-to-date information that we asked members of ESHRE’s Committee ofNational Representatives to summarise their local arrangements.

The result - in answers to a simple questionnaire - was completed byalmost all country representatives and now provides a unique snapshot

of how ART is organised and run throughout Europe.ESHRE itself has conducted such surveys before, but not with the

same blanket coverage, nor in such detail, and we are very grateful tothe CNR for their co-operation. A summary of the results is presentedin table form below. In all cases we have had to summarise theinformation provided by each country into note form (for reasons ofspace), so we hope our interpretation is accurate and a fair reflection of



Notes to the table1. Austria. Since February 2015. one embryo/blastocyst to be transferred; a decision to transfer two must be documented (female age, embryo quality,previous failed cycles). Reimbursement is set at 70% of a fixed price for IVF or ICS (treatment + medication). Four cycles (fresh and/or frozen) are funded. 2. Belgium. Number of embryos for transfer:<36 yrs: 1st transfer max one embryo; 2nd transfer one or two embryos; 3rd transfer max two embryos36-39 yrs: 1st transfer max two embryos; 2nd transfer max two embryos; 3rd transfer max three embryos40-42 yrs: 1st-3rd transfer unlimited3. Bulgaria. Number of embryos for transfer:<38 yrs: three cleavage stage embryos, two blastocysts; two embryos with assisted hatching; four embryos after cryopreservation>38 years, and/or more than two unsuccessful attempts: four cleavage stage embryos; three blastocysts; three embryos with assisted hatching; four embryosafter cryopreservation4. Croatia. ≤38 years two embryos; >38 years three embryos5. Estonia. Up to three embryos, and up to 50 yrs of age. Non-anonymous in egg donor cases unless the donor is a relative of the recipient6. Finland. PGD reimbursed only for genetic transmitted diseases7. France. Two embryos max - any more must be documented. No restrictions according to age.8. Germany. A general restriction to three embryos according to the Embryo Protection Law; however, professional guidelines recommend two up to the ageof 38 (and three after). PGD only allowed with ethical approval. PGS only permitted on polar bodies. Embryo freezing only allowed in emergency (PNfreezing allowed without restriction).9. Greece. Two embryos up to age 38 (three after three failed cycles). The couple can apply for reimbursement of 300 euro after every cycle. 10. Hungary. The law allows a maximum of four embryos transferred but the professional guidelines breaks it down according to age groups: <35 1-2; 35-401-3; >40 max 4.11. Ireland. No more than three embryos at any age by self-regulation. No legislation to ban any procedures, though law in preparation to make gametedonation non-anonymous. Medication costs only are covered after 144 euro.12. Italy. There are also 21 private clinics providing state services.13. Lithuania. There is no specific law regulating infertility treatment, although some aspects are regulated in other legislation - for example, legislation in1999 ruled that no more than three embryos could be transferred in women under 45. 14. Macedonia. Two embryos if first IVF attempt or patient younger than 35 yrs. Max three embryos if has had more than two IVF failures or is older than35 yrs. 15. Netherlands. Single embryo transfer in the first two cycles of IVF/ICSI in women under the age of 38. Only one centre (Maastricht) is permitted toperform PGD, but only in the framework of a scientific study.16. Poland. Legislation is now being prepared by the Polish government. SET recommended in young women; <35 yrs maximum two embryos transferred.17. Portugal. Only infertile heterosexual couples are allowed ART (including IUI). No single women or lesbian couples. Public health service limits thenumber of cycles (with embryo transfer) to three per couple and women below 40 years. No limits in the private sector.18. Romania. EU Directives incorporated in national legislation. No specific ART law, but is regulated in health legislation. No set limit on number ofembryos transferred, but the majority of transfers are with 1 or 2 embryos. Romania had an ART reimbursement programme for 18 month (01.06.2011-31.12.2012), which hopes to restart this year.19. Serbia. Three embryos maximum, regardless of age. No reimbursement for azoospermia.20. Slovenia. Maximum three ( by law) but practically only two (by professional guidelines), including insurance/professional guidelines for only one goodquality embryo in first two cycles in patients under 36 yrs.21 Spain. Three maximum. Own eggs 40,000 cycles per year; donor eggs 15,000; frozen embryo replacement 20,000; PGD 4000.22. Sweden. ‘As a rule, only one embryo should be transferred. If the risk for a twin pregnancy is considered small, two embryos may be transferred.’ Noreference to age. PGS only performed in a research setting with ethical approval and informed consent. Three pick-ups reimbursed - until live birth. Publiccentres may only treat patients eligible for reimbursement.23 Switzerland. Three at any age.24. Turkey. One for women under 35, and max two for women over 35 and with at least two implantation failures.25. UK. 40 yrs and under: one or two embryos (SET preferred); 40 or over: max three embryos (unless with donor eggs). Donor information held by regulatoruntil offspring reaches 18.

ART regulation and reimbursement in EuropeContinued from previous page

each country’s situation. Details related to embryo transfer andreimbursement eligibility have been added as footnotes.

What does the snapshot tell us? First, there is increasing evidence ofhomogeneity among countries. Many of the regulatory anomaliesevident ten years ago have been removed, to be replaced by legislationand regulation more in line with a common theme. This is especiallyevident in the case of Austria, from where CNR members Thomas Ebnerand Ludwig Wildt reported that new legislation introduced in Februarythis year has now set a limit on the number of embryos for transfer andallowed PGD and (non-anonymous) egg donation.

Similarly, as a paper by Benagiano et al recently confirmed, thedraconian restrictions imposed by Italy’s Law 40 of 2004 have now allbut been dismantled. The proscribed treatments - involving gamete andembryo donation, PGD, embryo cryopreservation, and the transfer ofmore than three embryos - have now been largely reintroducedfollowing legal challenges in the Italian courts. It is also clear that many

of the countries of eastern Europe have finally introduced legislationwhere formerly there was none. Poland, for example, which has longagonised over ART in both its public and political arenas, is now finallypreparing legislation, having introduced reimbursement just two yearsago.

Other trends are similarly evident. Notably, IVF is now largelyprovided by a mix of private and public clinics in most countries ofEurope. Only in a few countries (notably, Belgium, Estonia, Greece,Finland, France, Slovenia and the Netherlands) are all (or almost all)patients generously and without exception fully reimbursed by stateschemes. But even though many countries do not meet these samestandards, almost all countries do now provide some state funding totheir citizens. However, while most countries seem happy to cover thecosts of medication, cryopreservation and frozen transfers in theirreimbursement schemes, none has so far extended their generosity toPGS or time-laspe microscopy.

COVER THEME



Notes to the table1. Austria. Since February 2015. one embryo/blastocyst to be transferred; a decision to transfer two must be documented (female age, embryo quality,previous failed cycles). Reimbursement is set at 70% of a fixed price for IVF or ICS (treatment + medication). Four cycles (fresh and/or frozen) are funded. 2. Belgium. Number of embryos for transfer:<36 yrs: 1st transfer max one embryo; 2nd transfer one or two embryos; 3rd transfer max two embryos36-39 yrs: 1st transfer max two embryos; 2nd transfer max two embryos; 3rd transfer max three embryos40-42 yrs: 1st-3rd transfer unlimited3. Bulgaria. Number of embryos for transfer:<38 yrs: three cleavage stage embryos, two blastocysts; two embryos with assisted hatching; four embryos after cryopreservation>38 years, and/or more than two unsuccessful attempts: four cleavage stage embryos; three blastocysts; three embryos with assisted hatching; four embryosafter cryopreservation4. Croatia. ≤38 years two embryos; >38 years three embryos5. Estonia. Up to three embryos, and up to 50 yrs of age. Non-anonymous in egg donor cases unless the donor is a relative of the recipient6. Finland. PGD reimbursed only for genetic transmitted diseases7. France. Two embryos max - any more must be documented. No restrictions according to age.8. Germany. A general restriction to three embryos according to the Embryo Protection Law; however, professional guidelines recommend two up to the ageof 38 (and three after). PGD only allowed with ethical approval. PGS only permitted on polar bodies. Embryo freezing only allowed in emergency (PNfreezing allowed without restriction).9. Greece. Two embryos up to age 38 (three after three failed cycles). The couple can apply for reimbursement of 300 euro after every cycle. 10. Hungary. The law allows a maximum of four embryos transferred but the professional guidelines breaks it down according to age groups: <35 1-2; 35-401-3; >40 max 4.11. Ireland. No more than three embryos at any age by self-regulation. No legislation to ban any procedures, though law in preparation to make gametedonation non-anonymous. Medication costs only are covered after 144 euro.12. Italy. There are also 21 private clinics providing state services.13. Lithuania. There is no specific law regulating infertility treatment, although some aspects are regulated in other legislation - for example, legislation in1999 ruled that no more than three embryos could be transferred in women under 45. 14. Macedonia. Two embryos if first IVF attempt or patient younger than 35 yrs. Max three embryos if has had more than two IVF failures or is older than35 yrs. 15. Netherlands. Single embryo transfer in the first two cycles of IVF/ICSI in women under the age of 38. Only one centre (Maastricht) is permitted toperform PGD, but only in the framework of a scientific study.16. Poland. Legislation is now being prepared by the Polish government. SET recommended in young women; <35 yrs maximum two embryos transferred.17. Portugal. Only infertile heterosexual couples are allowed ART (including IUI). No single women or lesbian couples. Public health service limits thenumber of cycles (with embryo transfer) to three per couple and women below 40 years. No limits in the private sector.18. Romania. EU Directives incorporated in national legislation. No specific ART law, but is regulated in health legislation. No set limit on number ofembryos transferred, but the majority of transfers are with 1 or 2 embryos. Romania had an ART reimbursement programme for 18 month (01.06.2011-31.12.2012), which hopes to restart this year.19. Serbia. Three embryos maximum, regardless of age. No reimbursement for azoospermia.20. Slovenia. Maximum three ( by law) but practically only two (by professional guidelines), including insurance/professional guidelines for only one goodquality embryo in first two cycles in patients under 36 yrs.21 Spain. Three maximum. Own eggs 40,000 cycles per year; donor eggs 15,000; frozen embryo replacement 20,000; PGD 4000.22. Sweden. ‘As a rule, only one embryo should be transferred. If the risk for a twin pregnancy is considered small, two embryos may be transferred.’ Noreference to age. PGS only performed in a research setting with ethical approval and informed consent. Three pick-ups reimbursed - until live birth. Publiccentres may only treat patients eligible for reimbursement.23 Switzerland. Three at any age.24. Turkey. One for women under 35, and max two for women over 35 and with at least two implantation failures.25. UK. 40 yrs and under: one or two embryos (SET preferred); 40 or over: max three embryos (unless with donor eggs). Donor information held by regulatoruntil offspring reaches 18.

each country’s situation. Details related to embryo transfer andreimbursement eligibility have been added as footnotes.

What does the snapshot tell us? First, there is increasing evidence ofhomogeneity among countries. Many of the regulatory anomaliesevident ten years ago have been removed, to be replaced by legislationand regulation more in line with a common theme. This is especiallyevident in the case of Austria, from where CNR members Thomas Ebnerand Ludwig Wildt reported that new legislation introduced in Februarythis year has now set a limit on the number of embryos for transfer andallowed PGD and (non-anonymous) egg donation.

Similarly, as a paper by Benagiano et al recently confirmed, thedraconian restrictions imposed by Italy’s Law 40 of 2004 have now allbut been dismantled. The proscribed treatments - involving gamete andembryo donation, PGD, embryo cryopreservation, and the transfer ofmore than three embryos - have now been largely reintroducedfollowing legal challenges in the Italian courts. It is also clear that many

of the countries of eastern Europe have finally introduced legislationwhere formerly there was none. Poland, for example, which has longagonised over ART in both its public and political arenas, is now finallypreparing legislation, having introduced reimbursement just two yearsago.

Other trends are similarly evident. Notably, IVF is now largelyprovided by a mix of private and public clinics in most countries ofEurope. Only in a few countries (notably, Belgium, Estonia, Greece,Finland, France, Slovenia and the Netherlands) are all (or almost all)patients generously and without exception fully reimbursed by stateschemes. But even though many countries do not meet these samestandards, almost all countries do now provide some state funding totheir citizens. However, while most countries seem happy to cover thecosts of medication, cryopreservation and frozen transfers in theirreimbursement schemes, none has so far extended their generosity toPGS or time-laspe microscopy.

human beings with a rich and importantcontext, who could participate in theprocess. They challenged us with theobservation that we as professionals didnot make use of this latent power ofpatients. On the contrary, we raisedbarriers for their participation, such aswaiting-lists for consultations or adenial of their wish to share medicalrecords.

This meeting caused a real paradigmshift in how we did IVF. We came torealise that our work should not beabout what doctors do, but about whatpatients expect. Not about us, but aboutour patients. So we decided to takeaction, and began with a digital IVFclinic. This was a website for patients

with online access to their medicalrecords, a chat-box, and a forum forquick questions to the team.3 Within afew months 80% of our patients hadproduced a profile and were active onthe website. Popular sections were theresults of fertilisation, the pictures ofembryos, and questions to the team.Inspired by the huge success of thisventure, we embarked on a series ofother patient-centred initiatives whichwe tried to combine with research (seebox on next page).

Patient-centrednessWhat is the background to thedevelopment of patient-centredness?Quality of care? Patient satisfaction? Or

fear the inevitable day on which I willbecome a patient.’ With these wordsthe celebrated paediatrician DonBerwick opened the 2009

International Forum on Quality andSafety in Berlin.1 Berwick was notexpressing concern about the errors andlack of reliability in healthcare; he couldstand guard against them alongside thefine skills and good hearts of hiscaregivers. No, what he feared was to bea patient for other reasons. He was afraidof losing his dignity, his influence andhis individuality. ‘I fear to be no longermyself,’ he said.

A paradigm shiftBerwick does not stand alone. As headof the Nijmegen IVF team, I sensed thisvery same feeling for the first time in2001. We had organised a focus groupfor infertile couples and were keen tohear their opinion of the care weprovided.2 At the time we thought wedid it quite well, offering a high qualityservice. However, our patients hadthought differently.

Although they appreciated the qualityof our medical care, they felt we did notsucceed in delivering the sort of carewhich showed respect for theirindividuality. They experiencedfragmentation, disrupted continuity, anda lack of influence. Some of them told usthat they felt like passive objects, simplyto be repaired by us, and not as active

COVER THEME ‘The guidance of clinical decisions bypatient values is the crucial pillar of

patient-centredness.’

Patient-centredness

Confessions of a convert

Putting patients themselves at theheart of their fertility treatment isa mark of quality care. Patient-centredness, argues Jan Kremer,is about guidance through theclinical process by the values of

patients themselves.

I



decisions.’11 The IOM recognised theimportance of patient-centredness,explaining that it is one of the sixdimensions of quality of care. 1. Safety 2. Effectiveness3. Efficiency4. Timeliness5. Equity of access6. Patient-centredness

is the concept too soft for doctors, andbetter left to nurses or social workers?Reasons enough to consult theliterature and see what’s known.

The Institute of Medicine (IOM)defines patient-centredness as ‘Beingrespectful and responsive to theindividual patient’s preferences, needsand values, while ensuring that thepatient’s values guide all clinical

Examples of patient-centred initiativesPreventing emotional problemsInfertility and its treatment can be associated with emotional problems whichare important for patients. We developed a screening test to predict anxiety anddepression after IVF.4 Subsequently, we have designed and tested an onlinecognitive behavioural therapy to prevent these problems in women at risk(submitted).

Guideline developmentClinical guidelines are tools for professionals to improve infertility care and todecrease practice variation. Doctors mostly write them, although patients areincreasingly involved. We developed an innovative method for patientparticipation in guideline development. This online wiki was used by patientsand resulted in a set of patient recommendations that are now part of theDutch guideline for infertility.5

Guideline implementationWe know that writing guidelines does not imply their automatic use in dailypractice. That would not be good from the patient perspective. So we askedpatients to help in the correct use of guidelines. They were encouraged to givedirect feedback to their doctors, based on summaries of the guidelines in laylanguage.6

Shared decision making One of the important decisions in IVF concerns the number of embryos totransfer. The common belief is that patients choose two instead of one moreoften than doctors. We found it important that the personal context of thepatient was taken into account and developed a decision aid. We asked patientsto make the decision after having read and discussed this leaflet. A randomisedtrial showed that patients actually made the one embryo decision more oftenthan their doctors, contrary to expectations.7

Measuring and improving patient-centredness We want to understand and improve the quality of care through the eyes of ourpatients. First, we developed a questionnaire based on the eight Pickerprinciples of patient-centred care.8 Second, in wishing to improve patient-centredness we showed that feedback alone was not enough. Thus, wedeveloped a multifaceted intervention with a leading role for patients, whichshowed positive effects in a cluster-randomised trial.9

Personal health recordIf our aim is to respect and respond to patient values and needs, data storagefrom the perspective of the doctor in a medical record seems a strange choice.That’s why we developed a personal record which is owned by the patient(www.mijnzorgnet.nl). We tested this platform in IVF patients and showedpromising improvements in care.10

So quality of care is more than justmedical effectiveness, which in our fieldis so often reduced to pregnancy rate.Indeed, the recognition of patient-centredness as a dimension of quality ofcare is especially important, becausepatient-centredness is not the route tothe point, but the point itself. We candevelop outcome indicators for it, we canmeasure it, and we can improve it.

So the IOM definition is important butit remains vague to many of us anddemands further clarity. And here theprinciples of the Picker Institute(www.pickereurope.org) may be helpful.They distinguish eight dimensions ofpatient-centredness:

1. Access to care (eg, waiting times,reimbursement)2. Respect for patient values, preferences,needs (eg, shared decision making)3. Coordination and integration of care(eg, collaboration between specialists)4. Information, communication andeducation (eg, websites, patient leaflets)5. Physical comfort (eg, pain relief duringovum pick-up)6. Emotional support and alleviation offear and anxiety (eg, social work)7. Involvement of family and friends (eg,involvement of the partner)8. Transition and continuity of care (eg,one doctor)

Reading this subdivision of care, one isaware that patient-centredness is muchmore than just being nice to patients. It isabout guidance through the clinicalprocess by the values of patientsthemselves. This is so much more thanpatient satisfaction, which is a verysubjective concept, but about realexperiences which can be measuredobjectively.8

One could ask: Why is patient-centredness the ‘good’ thing to do? Whatis the moral nature of patient-centredness? Duggan tried to answer anddistinguished three schools of thought:that the basis of the activity is ‘good’(deontological school); that the activityitself is ‘good’ (virtue school); or theconsequence of the activity is ‘good’(teleological school).12 It’s true that inour present circumstances we focusprobably too much on the consequencesof patient-centredness (eg, saving money,improving medical outcome) and toolittle on the fundamentals (eg, seeingpatients as people) or virtues (eg, havingmeaningful and nice work). For example,



many people asked me whether ourdigital IVF clinic actually saved moneyor improved outcome (consequences) -and only a few people asked whether itwas fun to take part (virtue).

The next stepIn the early years we focused ourpatient-centred activities at the level ofpatient groups, which was in line withthe then dominant principle ofstandardisation. However, because theguidance of clinical decisions by patientvalues is the crucial pillar of patient-centredness, we now realise more andmore that that those values actuallydiffer from one person to the next anddepend on the social, psychological,physical and spiritual context of eachindividual patient. So, opting for patient-centred care also means opting for amore personalised way of working,which may well be the next fundamentalstep in evidence-based medicine. Youcan call it person-based medicine if youwish, but I am sure that this trend willhave a big impact on our work the nextdecade.

So, it is time for action. It’s time toimprove our IVF services to patients in away which respects their preferences,needs and values. Hopefully, this willbring us to a situation where they are nolonger afraid to be patients. As DonBerwick also said: ‘We should not behavewith patients as hosts in our system, butas guests in their lives.’

N, et al. Feasibility of screening patients foremotional risk factors before in vitrofertilization in daily clinical practice: aprocess evaluation. Hum Reprod 2012; 27:3493-3501.5. den Breejen EM, Nelen WL, KnijnenburgJM, et al. Feasibility of a wiki as aparticipatory tool for patients in clinicalguideline development. J Med Internet Res2012; 14: e136. Mourad SM, Hermens RP, Liefers J, et al. Amulti-faceted strategy to improve the use ofnational fertility guidelines; a cluster-randomized controlled trial. Hum Reprod2011; 26: 817-8267. van Peperstraten A, Nelen W, Grol R, et al.The effect of a multifaceted empowermentstrategy on decision making about thenumber of embryos transferred in in vitrofertilisation: randomised controlled trial. BMJ2010; 341: c2501.8. van Empel IW, Aarts JW, Cohlen BJ, et al.Measuring patient-centredness, the neglectedoutcome in fertility care: a randommulticentre validation study. Hum Reprod2010; 25: 2516-2526.9. Huppelschoten AG, Nelen WL, et al.Improving patient-centredness in partnershipwith female patients: a cluster RCT in fertilitycare. Hum Reprod 2015. pii: dev041. [Epubahead of print]10. Aarts JW, Vennik F, Nelen WL, et al.Personal health communities: aphenomenological study of a new health-careconcept. Health Expect 2014. doi:10.1111/hex.12177.11. Institute of Medicine. Improving the 21stcentury healthcare system. Crossing theQuality Chasm. A New Health System for the21st Century. Washington, DC: NationalAcademy Press 2001, 39–60.12. Duggan PS, Geller G, Cooper LA, BeachMC. The moral nature of patient-centredness:is it "just the right thing to do"? Patient EducCouns 2006; 62: 271-276.

Professor Jan A. M. Kremer is agynaecologist at Radboud universityNijmegen Medical centre, Nijmegen, theNetherlands. he was formerly Professorof Reproductive Medicine and iscurrently Professor in patient-centeredinnovation.

1. Berwick D: What patient centred carereally means.http://www.youtube.com/watch?v=SSauhroFTpk 2. Kremer JAM, Barneveld J, Braat DDM.Het Ooijpoldermodel: de patiënt centraal inhet regionale netwerk van fertiliteitzorg. NedTijdschr Obstetrie en Gynaecologie 2002;115: 208-210.3. Tuil WS, ten Hoopen AJ, Braat DD, et al.Patient-centred care: using online personalmedical records in IVF practice. HumReprod 2006; 21: 2955-2959. 4. Van Dongen AJ, Kremer JA, Van Sluisveld

Patient notes, medical records are now online and accessible by patients themselves.

JAN KREMER: ‘wE PROBABLYFOcus tOO Much ON thEcONsEquENcEs OF PAtiENt-cENtREdNEss (eg, sAviNgMONEY, iMPROviNg MEdicALOutcOME) ANd tOO LittLEON thE FuNdAMENtALs (eg,sEEiNg PAtiENts AsPEOPLE) OR viRtuEs.’



n recent years the importance of infertilitycounselling has been increasingly recognised inmany countries. This is not only reflected in thenumber of professional books on infertility

counselling, but also in the development of guidelinesby infertility counselling organisations,1 not least bylatest guidelines on Routine psychosocial care ininfertility and medically assisted reproduction – A guidefor fertility staff, from ESHRE’s SIG Psychology &Counselling. Here, we will provide a short overview ofthe issues and challenges that remain to be tackled inthe near future. These include the ongoing endeavourto make counselling a routine option for couplesseeking fertility treatment, the challenges forlegislative and societal development with respect toanonymity and openness in third-party reproduction,

and the need for basic and advanced training forpsychosocial professionals.

Routine infertility counselling and/or counsellingfor specific psychosocial issues?Currently there is no consensus among professionalsregarding the provision of routine infertilitycounselling for all patients starting or having ART. In anumber of countries, clinics do have a mental healthprofessional (such as a psychologist, social worker orpsychiatrist) on staff with specific expertise in thepsychological aspects of (in)fertility. They providesupport in a number of predefined indications.Historically, this has focused on support for patientswho experience high levels of stress as a result of theirinfertility and/or its treatment, which may have a

The routine option: what the futureholds for fertility counselling

COVER THEME

Uschi Van den Broeck and Petra Thorn, present and past co-ordinators of ESHRE’s SIG Psychology &Counselling, on the challenges now facing counsellors as clinics move towards greater patient-centred care.

I



in several ways: closer collaboration between themedical and the psychosocial fields will result inmore intending parents seeking counsellingprior to medical treatment; more options forthird party conception will result in a higheruptake; greater social acceptance of this family-building treatmemt will result in a higherdisclosure rate; and - very likely - more parentswith older children will seek support fordisclosing the nature of the conception to theirchild. For many counsellors, these will presentnew or extended dimensions to their work andthey may benefit from training.

Towards European training and educationThe need for specialist training has beenrecognised by several European infertilitycounselling organisations. For the last threeyears, the German Society for FertilityCounselling (www.bkid.de) has been conductingmany training courses for psychosocialprofessionals for both general infertilitycounselling and for advanced counselling (suchas in third-party conception). The BritishInfertility Counselling Association(www.bica.net) is offering foundation courses todevelop specialist knowledge and skills as well asstudy days on specific issues. In addition, the

International Infertility Counselling Organisation(www.iico-infertilitycounseling.org) as theinternational umbrella organisation, together withnational organisations, has conducted a number ofpostgraduate workshops.

Several EHSRE SIGs have now developed aEuropean-wide recognised accreditation system fortheir members. We hope that in the near future,ESHRE’s SIG Psychology & Counselling will also beable to provide such accreditation and thus contributetowards greater recognition and accountability of theirprofessional qualifications and skills. Such Europe-wide standards for infertility counsellors should beconsidered in order to enhance the professionalisationof counselling in our field. We also hope that in thenext years, our SIG will be able to provide basic andadvanced training workshops open to anyprofessionals in the field of human reproduction whointend to increase their psychosocial skills.

uschi van den Broeck is a clinical psychologistspecialising in family and couple therapy at theuniversity hospital, Leuven, Belgium, and co-ordinatorof EshRE’s sig Psychology & counselling. Petra thorn is a consultant fertility therapist based inMoerfelden, germany, and was co-ordinator EshRE’ssig Psychology & counselling from 2009 to 2011.

1. Blyth E. Guidelines for infertility counselling in differentcountries: Is there an emerging trend? Hum Reprod 2012; 27:2046-2057.2. Dancet EA, Nelen WL, Sermeus W, et al. The patients’perspective on fertility care: a systematic review. HumReprod Update 2010; 16: 467-487.

negative impact on various aspects of their livesand partner relationship. More recently,counselling organisations are moving towardsinternational consensus for counsellors to meetwith couples considering third-party conception.In addition, counsellors are ideally placed toprovide supervision to medical team members.

As the field of reproductive medicine hasevolved, various specific issues have arisen.These include couples presenting with HIV, theneed for fertility preservation prior tooncological treatment, the desire for socialfreezing, sexual issues and dysfunctions, cross-cultural questions and cross-border reproductiveservices, transgender individuals seekingtreatment, preconceptional care and lifestylechallenges. Many of these bring about veryspecific, and often unexplored, psychologicaland societal challenges.

In addition, various ethical and legalchallenges remain to be tackled. Infertilitycounsellors will thus have to develop theirresponsibilities to provide specialisedpsychosocial care for patients dealing with thesecomplex issues, while at the same timeproviding expertise and education for their(para)medical team members in these evolvingpsychological developments and theirimplications.

Routine psychosocial care by all fertility clinic staffRecent years have also witnessed an important movetowards greater focus on patient-centred care.2 It thusseems clear that infertility counselling must be betterintegrated into medical treatment and that closercollaboration between medical and mental healthprofessionals is vital. A current example of suchcollaboration is the new ESHRE guideline on routinepsychosocial care in infertility just published (seepage 13). These are the first such evidence-basedguidelines within the infertility field. They offer bestpractice advice to all fertility clinic staff (doctors,nurses, midwives, counsellors, social workers,psychologists, embryologists, and administrativepersonnel) on how to incorporate psychosocial careinto routine infertility care.

Future challenges in third party conceptionThird-party conception has been increasinglyrecognised as a legitimate and positive family buildingoption. This is not only reflected in changinglegislation (such as in Austria where oocyte donationas well as donor insemination for lesbian couples hasnow been legalised), but also in high court decisionswhich recognise this option, granting children theright to access their biological origins (as inGermany). At least in Europe, this shift seems to bemore towards pre-treatment counselling and psycho-education than in screening for all parties involved inthird-party conception.

These changes will have an impact on counselling

Petra Thorn, top,and Uschi Van denBroeck: ‘It thusseems clear thatinfertility

counselling must bebetter integratedinto medicaltreatment.’



COVER THEME

‘Infertility is like a bereavement which hits meafresh every month, for which I can’t see a wayto grieve, and from which I can’t move on . . . ‘

The above description was sent to a volunteerorganising a fund-raising event for the patientorganisation I work for, Infertility Network UK (I NUK). I think it demonstrates the emotional impactinfertility has for many people.

There are patient organisations throughout Europeproviding practical and emotional support for thosewith difficulties in conceiving. Why are theseorganisations important? The emotional impact ofinfertility is well documented, with numerous studiesreported over the years. The physical impact, however,is also very real, with invasive investigations andtreatments often lasting for several years. For patientsto feel in control and informed about what ishappening to them is extremely important.

The emotional tollThe UK patient organisation Fertility Fairness(previously known as the National InfertilityAwareness Campaign) surveyed patients in 1997looking at the emotional and financial impact ofinfertility1. A second survey was performed 16 yearslater by I N UK to see whether the emotional impacthad changed.2 We found that those who experiencedtearfulness/sadness and anger were very similar in2013 as in 1997; 65% said that they had experienceddifficulties in relationships with family and friends.However, those who had experienced loss of sex drive,guilt and shame were significantly fewer.

Unfortunately, many of those who have neverexperienced infertility lack understanding of just whatinfertility is like and can make comments which lacksympathy and insight. It’s now easy to read a newspiece about infertility or an interview with a patient tosee the negative and some downright cruel commentsfrom the ill-informed fertile majority - such as ‘Can’tscientists spend their time finding a cure for broodywomen who simply must procreate at any cost insteadof helping them to do it?’3

Family and friendsPeople with fertility problems may find it useful totalk to family and friends about the way they feel. Forsome, however, this isn’t an option. They may notwant to share their problem with people close tothem. We quite often hear that close family andfriends find it hard to empathise with fertility

problems. They can often be unhelpful, saying, ‘Justrelax and you’ll get pregnant’. Well, sometimes that justisn’t true.

It was for these reasons that the Clinical Guidelineon Fertility published in 2013 by the UK’s NationalInstitute for Health & Care Excellence (NICE) madethe recommendation in its section on Principles ofCare that ‘people who experience fertility problemsshould be informed that they may find it helpful tocontact a fertility support group.4

The benefits of belonging to a patient organisationAccess to personal experiences. The benefit of beingable to talk to others with similar experiences areplenty. It removes the feeling of isolation.Access to good information. Patient groups canprovide good quality, up to date, medically accurateinformation on almost every form of treatment, causeof infertility and related subjects.Self help/mutual help. Talking to others in the samesituation helps all parties involvedKnowing you are not alone. Belonging to a patientsupport group makes patients realise they are notalone and goes a long way to removing that feeling ofisolation.

In August 2006 I N UK performed a survey of itsmembers with 150 respondents. When asked whetherthey felt that belonging to the organisation had helpedthem in the management of their illness andtreatment, 121 (81.5%) said that it had, with just 12(8%) responding No and seven not sure.

How can clinics help? Hand information on local patient organisations into each and every patient – don’t just leave theirleaflets in the waiting room Recommend the organisation to your patients

What patient groups can do for your patientsClare Lewis-Jones MBE, chair of Fertility Europe, a founding member of Britain’s first patient organisation, and a former member ofthe UK’s regulatory authority, finds support group benefits in access to good information, mutual help and shared experience.

They want to talk to other infertility sufferers They feel the clinic is too busy to answer their questions and/ordon’t know who to speak to They feel that infertility is putting pressure on their partner They feel that it reinforces a sense of failure in their partner They feel partner/family/friends are fed up of listening They feel they have to be seen to be coping by the clinic The bad news has only really hit them when they get home They want to find out why treatment was unsuccessful

Reasons why patients may contact a patient organisation



Counselling should be available at ALL stagesof treatment - before, during and after treatment Explain the benefits of counselling and how toaccess it to ALL patients Link your website to local patient organisations Give patients written information on all aspectsof their investigations and treatment throughouttheir time at the clinic in a range oflanguages/formats Ensure patients know who to contact if theyhave questions or concerns Provide access to a counsellor - within theclinic and outside Provide an area or space where patients can gofor privacy

And finally, patient organisations need morefinancial support. Otherwise, there is a dangerthat many cannot continue. Very few haveguaranteed funding and must generate their own

income, which is extremely difficult. So pleasesupport the patient organisation with funding –or help with recruiting volunteers. Even thosepatient organisations with paid staff would stillnot be able to provide all their services withoutthe help of their wonderful volunteers.

1. Kerr J, Balen A, Brown C . The experiences ofcouples in the United Kingdom who have hadinfertility treatment – the results of a survey performedin 1997, Hum Reprod 199; 14: 934-938.2. https://healthunlocked.com/infertility-uk/polls/131180409/did-you-receive-the-emotional-support-you-felt-you-needed-from-your-clinic-whilst-undergoing-fertility-investigations-and-or-treatment/result. 3. http://www.dailymail.co.uk/health/article-2280264/Women-40-IVF-NHS-time-new-guidelines-week-lesbian-couples-benefit.html4: http://www.nice.org.uk/guidance/cg156

This is a big year for Fertility Europe. It’s been three yearssince our last election of members to the ExecutiveCommittee and it’s time for new elections. This time we’velooked to other societies and associations, such as ESHRE,and are changing our election process.Instead of electing the entirecommittee once every three years, wewill be having annual elections whereonly one or two members will beelected, ensuring continuity in thework being done.

We have also noticed in our workthat more and more attention is beingpaid to the voice of the patient. Lastyear we were asked to co-chair anESHRE precongress course on ‘newgeneration patients’. It was a greatexperience and important to see suchrespect for the voice of the patientduring the course. In the past ourfeeling has been that those working inthe field have been talking about theirpatients, but not so much with them.So this is a noticeable change andESHRE and its members should beacknowledged for their part in it.

Fertility Europe continues with its

policy work, which is greatly appreciated by our membercountries and other parties. Some of our members havesuccessfully used our policies to influence their governmentsin matters related to fertility treatments.

The Special Families Campaign and Wall of Hope continueto be the projects that give us the greatest visibility. We havegreat ideas and hopes for Lisbon and look forward to sharingthem with you. It's been great to see the Wall of Hope

growing from 250 postcards inStockholm to more than 1000 in ouronline galleries. These postcards havestories from all sorts of people from allover the world. Our main focus hasbeen on Europe, but the word hasspread and we now have cards fromboth Canada and Brazil and one neverknows where the next one will comefrom. Many people gather around theWall of Hope during ESHRE's AnnualMeeting, looking at the postcards andtaking pictures. It’s greatacknowledgement of the work we’vedone so far.

Hopefully we can continue to inspireyou with more stories and picturesfrom the people behind the treatments.This year Fertility Europe’s stand willbe with the Wall of Hope in theentrance hall – so do come and see us.

Elín EinarsdóttirSecretary of Fertility Europe

More talking with the patientthan about the patient

Clare Lewis-Jones: ‘Forpatients to feel in control ofwhat is happening is very

important.’


CAMPUS MEETING: REPRODUCTIVE GENETICS

Those hoping for definitive conclusions from theUpdate on PGS Campus meeting held in Rome inMarch would have been somewhat disappointed. Eventhe current 24-chromosome screening ‘consensus’now drifting over the Atlantic (blastocyst biopsy,whole genome amplification techniques) was by nomeans accepted by all, and consensus here in Romewas not built in a day.

One of the course organisers, former PGDConsortium Chair Joyce Harper, said she hoped allattending ‘would be convinced that PGS is a viableprocedure’, but by the end of this two-day meetingeven she admitted that ‘we’re not at that point yet’. Thetechniques themselves, the timing of theinterventions, and the patient groups most likely tobenefit were all topics for clarification.

Indeed, it was a sign of the uncertainty stillsurrounding PGS that so many took part in the event.More than 150 registered for the meeting, which wasorganised by the PGD Consortium and SIGReproductive Genetics.

The meeting kicked off with the premise that ‘we’vemoved away from cleavage-stage biopsy’ and thatblastomere analysis by FISH ‘is redundant’. There was

not much doubt about that, even though the latestdata from the PGD Consortium suggest that cleavagestage biopsy is still commonly applied. Nevertheless,while Edith Coonen, Chair of the Consortium,methodically explained why FISH ‘had failed’(technical artefacts, mosaicism), one after anotherspeaker reviewed their data from the next WGA phaseof PGS: Nathan Treff on quantitative PCR ontrophectoderm cells (‘inexpensive, fast, flexible andsimple’), Joep Geraedts on array CGH on polar bodies,and Francesco Fiorentino on array CGH and next-generation sequencing.

However, it was Treff, in his presentations on qPCRand trophectoderm biopsy who explored the questionof timing and the best stage of embryo developmentfor analysis. Treff 's case in favour of blastocyst biopsyrested largely on one RCT, although he noted too thatthe three RCTs so far showing a benefit ofcomprehensive chromosome screening were all withblastocyst biopsy (albeit in good responder patients).1Results from this trial suggested that cleavage-stagebiopsy is detrimental to the implantation potential ofthe embryo, which is not evident in trophectodermbiopsy. Results of the study showed that only 30% of

biopsied embryos had implanted anddeveloped into live births, against 50% ofunbiopsied controls; in contrast,implantation rates were equivalent (51%vs. 54%) for both the biopsied andcontrol blastocysts, reflecting animplantation benefit for the biopsiedblastocysts over the day 3s.

However, it seemed somewhatdisconcerting for many in the audience tolearn that at least two large groups (IVI inSpain and IVF Melbourne) continued torely on day 3 biopsies - and with goodresults. The danger of blastocyst biopsy,as several speakers pointed out, is thatsome embryos will simply not make it today 5, with the result that many patientswill have no transfer. Dagan Wells notedthat some 50% of IVF patients over 40would not reach embryo transfer in day5-biopsy programmes. And Fiorentinohimself, while reporting updated results

Update on PGS failsto deliver consensusA Campus meeting organised by the SIG Reproductive Geneticsand PGD Consortium aimed for consensus, but even some ofthe world’s leading experts in the field found little unanimity in

their choice of technique or timing of biopsy.


Speakers at the Rome meeting. From left, Florence Belva, Edith Coonen, Luca Gianaroli,Joris Vermeesch, Dagan Wells, Cristina Magli, Francesco Fiorentino, Joep Geraedts,

Nathan Treff, Maaike Haadsma, Ursula Eichenlaub-Ritter.


from a small trial of array CGH on day 3 embryos,agreed that the procedure still ‘had potential toimprove IVF efficiency’, though he was cautious aboutover-interpretation (‘I can't say that these resultsdemonstrate anything’).

In response, Cristina Magli from SISMER in Bolognaargued that day 3 biopsy should not be abandoned,while Leeanda Wilton from Melbourne, speaking fromthe floor, insisted that ‘the best labs should be able todo both [day 3 and day 5] biopsies well’.

This flexibility of approach seemed also the caseproposed by Dagan Wells, who set out the advantagesand disadvantages of polar body biopsy (leastinvasive, ethically acceptable, more time foranalysis, no mosaicism - but no paternalanomalies, and only 95% predictive value),cleavage-stage biopsy (more embryos fortesting, but risk of damage, with prevalentmosaicism), and blastocyst biopsy (more cellsfor testing, less mosaicism, but fewer embryosavailable and a shorter time for analysis if notfreezing). But, said Wells, blastocyst biopsy isthe current ‘trend for the field’, with ‘a luxuryof genetic material’.

However, while noting that trophectodermtesting is ‘probably ideal’, Wells reported that‘there still remains a role for all biopsy stages’ -though despite a diagnostic failure rate of 0%,he still emphasised the importance of trainingin the blastocyst biopsy technique, andshocked many in the audience by disclosingthat as many as 18% of cells sent to his Oxfordlab for testing were not suitable for analysis.


This was not an encouraging meeting foraneuploidy screening by polar bodyanalysis. First, Nathan Treff argued withevidence from several studies that polarbody analysis is less predictive ofreproductive potential than other CCSapproaches. Further, with reference toone of his own studies of 2010 (thoughnot an RCT), he claimed that the safety ofpolar body biopsy had not yet been'rigorously established' - despite theassumptions of their natural extrusion.Treff thus concluded that trophectoderm biopsy ispreferable to polar body in terms of cost, convenience,predictive value and outcome.It was therefore especially disappointing for all in the

audience to hear from Joep Geraedts that recruitment inthe ESTEEM trial - the one and only study currently able to

establish the credentials of polar bodybiopsy for aneuploidy screening - wasrunning behind schedule. A pilot study hadalready provided a proof of principle, butthe current multicentre trial in sevencentres had so far performed just 212transfers, considerably behind target. As aresult, said Geraedts, continued fundingfrom the trial's main sponsor, ESHREitself, was now in question. Morediscussion - with ESHRE and otherpotential sponsors - would now be

necessary to secure the trial's future.There was strong feeling in the audience that without the

ESTEEM trial the place of polar body testing foraneuploidy would remain in doubt, and a move to supportcontinuing funding for the trial had overwhelmingagreement.

Questions remain for aneuploidy screening by polar body analysis

Wells seemed also equivocal about the best testingmethod, but was quite clear (unlike many) about thegeneric value of PGS and its superiority overmorphology as a gold standard in embryo selection(for SET). The evidence, he said, was ‘accumulating’,and, whatever the arguments against PGS as a meansof embryo selection (as once again delivered by SjoerdRepping, see page 10), PGS would avoid thecryopreservation of aneuploid embryos, would reducetime to pregnancy, lower the miscarriage rate, andlower the risk of Down’s syndrome and otheranomalies. This opinion was also voiced by former

ESHRE Chairman Luca Gianaroli, who notedbenefits of overall cost and time to pregnancy inthe concept of PGS.

However, despite such claims, by the end ofthe meeting there was still no consensus onPGS. Both voting and opinions expressedreflected pros and cons for all methodologiesand an emerging feeling that any generalisationabout patient groups may not be the way to besttreatment. That, most agreed, will require theevidence of further RCTs, and a few more yearsyet to wait.

Simon BrownFocus on Reproduction

1. Scott RT Jr, Upham KM, Forman EJ, et al.Cleavage-stage biopsy significantly impairs humanembryonic implantation potential while blastocystbiopsy does not: a randomized and paired clinicaltrial. Fertil Steril 2013; 100: 624-630.

Joint course organiser JoyceHarper: Consensus on PGS

still elusive.


PARAMEDICAL GROUP3PGD CONSORTIUM3


SIG SOCIO-CULTURAL ASPECTS OF (IN)FERTILITY3The primary task of the ESHRE PGD Consortium is tocollect PGD data. In 15 data collections so far (dataXV including PGD cycles carried out between January-December 2012 with babies delivered up to 2013) datafrom over 58,000 cycles have been submitted to thedatabase. As such, this comprises the world’s largestcollection of PGD/PGS data, providing an extremelyvaluable resource for data mining and for followingtrends in PGD practice.

However, the submission of data is a difficult processfor our members and the Steering Committee wishes toacknowledge the effort of all contributing centres. As aresult of a huge increase in the number of reportedcycles each year, the Steering Committee has found itextremely difficult and time-consuming to mine thedata and produce accurate tables. Moreover, the natureof PGD/PGS treatments has changed significantly overrecent years and today we face complexity in IVF cyclemanagement and genetic analysis techniques.

As a result, the Steering Committee has found ittimely to rejuvenate our data collection and make itmore fit for purpose. To do so, we have invested time instrategic initiatives, first to determine whattechnologies are being used or introduced into geneticdiagnosis, and also how IVF cycles are being managedfor PGD. This information has allowed us torestructure data collection and mining and has led tothe creation of a new online PGD database.

The design of the new database will allow centres toinput and analyse their own data in real time. So, withthe database now ready, our focus will be to inspire andencourage all PGD centres to submit their data. Wecordially invite you to the launch of this new onlinedatabase during the Annual Meeting in Lisbon. Join theConsortium and find out more about the advantages ofthe online database. Add your data prospectively fromoocyte retrieval to analysis, from embryo transfer topregnancy and live birth. Keep track of your fresh andcryopreserved PGD/PGS cycles. Audit your centre’spregnancies and live births according to ART and

genetic analysis techniques. And last but not least,network with PGD practitioners, discuss trends andidentify good practice.

Working groupsBy their nature, our current data collections do notrepresent real-time trends in PGD or PGS. For thisreason the Steering Committee has formed a workinggroup to monitor new technologies in PGD and togather up-to-date information on developments in allaspects of PGD. A manuscript describing the results ofa survey performed in 2013 was sent to HumanReproduction, but reviewers suggested a further surveyto allow comparison between the two investigatedperiods. To that end, a second questionnaire will besent out in the weeks to come.

Another WG plans to look at collaborative workingpractices between Genetics and IVF teams whendelivering a PGD service. After a pilot evaluation bythe Steering Committee, it was decided to re-evaluatethe format of the questionnaire.

The WG on HLA has made good progress. An e-mailwas sent out to all potential participants, inside andoutside the PGD Consortium, inviting them toparticipate in a multicentre study that aims to evaluatethe overall clinical utility of HLA-PGD. We feel that anevaluation of the true clinical utility of HLA-PGD istimely and important so that prospective patients andmedical practitioners can be informed accordingly. Adatabase was set-up to facilitate retrospective (andpotentially prospective) cohort studies to investigateaspects of PGD cycles which influence a positiveoutcome (birth of a genetically suitable donor-baby)and to investigate clinical outcomes of bone marrowtransplant from PGD-selected donors. A good numberof PGD centres have responded positively, but wewould once more like to encourage centres that havenot yet responded to do so.

The ESHRE PGD Consortium continues to promotea high standard of PGD. With your help and input wecan make it work.

Edith CoonenChair ESHRE PGD Consortium

A new datacollection system‘more fit forpurpose’

New online database to beintroduced during Lisbon

Annual Meeting

Steering Committeeat its meeting inMarch. From left:Celine Moutou, JanTraeger-Synodinos(Past Chair),Georgia Kokkali,Sioban SenGupta(Chair-elect),Veerle Goossens(ESHRE ScienceOfficer), EdithCoonen (Chair),and Martine deRycke.


PARAMEDICAL GROUP3

All set for first nurse/midwifecertification exams in LisbonThe Paramedical Board ran a very successful Basic trainingcourse for Paramedics working in reproductive medicine inLisbon in March. This is the first time the course has been runin Portugal and 76 delegates attended. Feedback has been verypositive and I would like to thank all the speakers andorganisers for their support with this Campus course.

Lisbon will be the venue for the first Nurses and MidwivesCertification examination which will be held on Saturday 13June. Prospective candidates have submitted their Log Booksand will have received notification by e-mail about theexamination process. We wish all candidates the best of luckfor the forthcoming examination.

Sadly, we will say goodbye to Jolieneke Schoonenberg-Pomper in Lisbon, who will come to the end of her secondterm on the Board. As a previous Chair, Jolieneke has been a

great advocate for Paramedical members of the Society and hasalways worked hard for ESHRE. We are very pleased to say thatshe will continue to be involved as Chair of the steeringcommittee for the Nurse and Midwife Certification Course,which she has helped to develop.

On that note I am delighted to tell you that Valerie Blanchethas been appointed to the Paramedical Board as a nurserepresentative. Her position will be confirmed at the AnnualMeeting and we welcome her to our Board. Valerie was amember of the local organising committee for the basic trainingcourse held in Paris in May last year and I am sure she will be avery active board member.

As mentioned before, we are always keen to hear from ESHREParamedical Group members and would be pleased to see youat our AGM on Monday 15 June at 13.00. If there are anyburning issues or topics which you would like us to address orcourses that you feel would be valuable. please feel free tocontact me directly.

Helen Kendrew ([email protected])Chair Paramedical Board


SIG SOCIO-CULTURAL ASPECTS OF (IN)FERTILITY3Go ahead for Europe-wide survey on oocyte cryopreservationWe are pleased to confirm that ourEuropean egg-freezing project incollaboration with EIM has startedafter its approval by the ExecutiveCommittee in January. It has taken a lotof energy during our first year ofactivity, to finalise the protocol andquestionnaires. We are now gatheringinformation on the statutory or practical requirementsand status of current data collection for oocytestorage and their eventual use in most EU countries.Results are likely to be fairly heterogeneous and wehope the study will stimulate the prospectiverecording of data on the reasons and conditions foroocyte freezing in Europe, whether for medical ornon-medical reasons.

Among the many questions raised are whether thetechnique will have an impact on the furtherpostponement of child bearing, a theme whichcertainly has caught public attention. Indeed, the offerto their female work force by several companies maybe considered a real social advance for women, oralternatively a ploy to ensure keeping them employedwhen young and productive.

Another international issue of great societal concernin our field is surrogacy, even though its Europeanpractice is also very heterogeneous, as many countriesban it. Our junior deputy Virginie Rozée, asociologist, organised last November a meeting inMumbai on cross-border socio-cultural issues in ART,with the special dimension of North-Southinteraction, or high-and-moderate income countrieswith low-income countries. In Europe, surrogacy is

legal in the UK, Greece and theNetherlands, while unregulated butallowed in Belgium and the CzechRepublic. In low income countries,commercial surrogacy looms large, andis used by many foreign citizens living incountries where the technique is either

banned or regulated within ‘non-commercial’ boundaries.

The ethical issues concerning the possibleintrumentalisation of women have already been wellrehearsed (ESHRE TF Ethics & Law, FIGO), but thesocio-cultural aspects are also worthy of more detailedanalysis, which will appear in the planned publicationrelated to the Mumbai meeting. Virginie further plansa meeting on surrogacy next year in Paris, and we arelooking forward to a collaboration between our SIGand INED (the French National Institute ofDemographic Studies).

We will also take part in a workshop organised bythe SIGs Andrology and Ethics & Law next Decemberin Leuven on Donor sperm banking: medical, socio-cultural, ethical and legal considerations, and aprecongress course at the 2016 Annual Meeting inHelsinki with the SIG Early Pregnancy on Whathappens in utero lasts a lifetime: A multi-disciplinary approach to improving preconceptionand early pregnancy care.

We look forward to seeing many members at theseforthcoming events, as well as to your feed-back andsuggestions for future work.

Françoise ShenfieldCo-ordinator SIG Socio-Cultural Aspects of (In)fertility

Françoise Shenfield (GB), Co-ordinatorPaul Devroey (BE), Deputy Ana Pia Ferraretti (IT), DeputyVirginie Rozée (FR), Junior Deputy

STEERING COMMITTEE

Steering Committeeat its meeting inMarch. From left:Celine Moutou, JanTraeger-Synodinos(Past Chair),Georgia Kokkali,Sioban SenGupta(Chair-elect),Veerle Goossens(ESHRE ScienceOfficer), EdithCoonen (Chair),and Martine deRycke.


SIG REPRODUCTIVE ENDOCRINOLOGY3

Recurrent implantation failure on Lisbon agendaA Campus meeting on Old and new inreproductive endocrinology tookplace in Helsinki in April. Theprogramme covered the hormonalenvironment during pregnancy andearly stages of reproductivedevelopment, from the fetal period toadulthood, with a focus ondevelopmental disturbances ofreproductive organs during early and latereproductive life.

This year’s precongress course in Lisbon is titledWhen IVF fails: optimal management of recurrentimplantation failure. The course will provide acritical appraisal on recurrent implantation failure,one of the most difficult problems in IVF for bothpatients and physicians.

Future activitiesIn 2016 the SIG RE is preparing two Campus events:one in Istanbul on The ageing woman and her ovary,for which the programme has already been finalised,and a joint workshop with the SIG Reproductive

Surgery in Thessaloniki, which iscurrently in preparation. The Istanbulmeeting aims to increase understandingin female reproductive changes across thelifespan, with current and futureperspectives on treatment options forwomen of advanced reproductive age,and on the management of premature

ovarian insufficiency and menopause.The 2016 precongress course in Helsinki is titled

Managing the difficult IVF patient: Facts andfiction. The course will provide a guide to managingthe patient with advanced age, with extremely low orhigh BMI, and presenting with a thin endometrium.The course will also address recurrent implantationfailure and conception complicated by medicaldisorders. Attention will also be given to controversialtopics, such as the management of IVF patients withendometriomas or intramural fibroids as well as theprevention of discontinued IVF treatment.

Stratis KolibianakisCo-ordinator SIG Reprodcutive Endocrinology

[email protected]


STEERING COMMITTEEEfstratios Kolibianakis (GR), Co-ordinatorFrank J. Broekmans (NL), DeputyDaniela Romualdi (IT), DeputyTerhi Piltonen (FI), Junior DeputyGeorg Griesinger (DE), Past Co-ordinator

SIG STEM CELLS3

Strong stem cell representation in Lisbon - despite competitionWe have had some trepidation thisyear about stem cell abstractsubmissions to the Annual Meeting,Just a few days after Lisbon, theInternational Society for Stem CellResearch will hold its meeting - inEurope for the first time, and withhigh potential for low participationin ESHRE. So we are very happy toannounce that this year we scored 35 abstracts in stemcell research for Lisbon, and that the quality of thework presented was very high, covering bothpluripotent and progenitor cells, with a nice balancebetween basic and preclinical applied research.

Our precongress course ahead of the scientificsessions in Lisbon has been organised with the SIGEarly Pregnancy and will cover the role of stem cellsin the pathogenesis, modelling, and possible treatmentof several aspect of early pregnancy, from Asherman’ssyndrome to altered placentation.

Steering committeeOur meeting in Lisbon will also mark a change in theconstitution of the SIG SC. I will step down from myposition as Co-ordinator, to be replaced by Björn

Heindryckx from the University ofGhent. Björn has been a very activemember in the SIG for the last two years,participating in all activities andcommitted to improving the visibility ofstem cell research in ESHRE. FilippoZambelli will move on from JuniorDeputy to SIG Deputy, a very apt

promotion given his energy andcommitment. A new junior deputy will be electedshortly, following a round of nominations soon to beunder way.

This is also the last report that I write as SIG Co-ordinator, and I wish to leave thanking those whomade it possible - the staff at ESHRE’s Central Officefor their patience in explaining the workings of theSociety, and all the member of the SIG for their trustand confidence in me. I would like to close bythanking my predecessors Karen Sermon and AnnaVeiga for their strong commitments to stem cellresearch and leadership in the field. They have been agreat support and their work has enabled the veryexistence of a vibrant stem cell community in ESHRE.

Rita VassenaCo-ordinator SIG Stem Cells

STEERING COMMITTEERita Vassena (ES), Co-ordinatorCristina Eguizabal (ES), DeputyBjörn Heindryckx (BE), DeputyFilippo Zambelli (IT), Junior DeputyKaren Sermon (BE), Past Co-ordinator



SIG REPRODUCTIVE SURGERY3

Meeting reportsThe latest biannual endoscopy workshopwas successfully completed in Leuven inMarch. Of particular interest were theseveral hours of live surgery performedby Stephan Gordts, Sylvie Gordts, RudiCampo and Patrick Puttermans, whichincluded cases of hysteroscopictreatment of T-shaped uterus,transvaginal laparoscopic laser ovarian drilling, andlaparoscopic myomectomy. Participants had theopportunity to practice laparoscopic suturing and knottying for several hours over the three days of thecourse under the direction of Sylvie Gordts and YvesVan Belle. Additional lectures were included on thetopics of 2D and 3D assessment of the female pelvis,which has been gaining increasing popularity recently.

Our Campus workshop in Lyon on the 17-18 Aprilon Complications in endoscopic surgery wasorganised by Deputy Co-ordinator Antoine Watrelot.Sessions included the incidence, prevention andmanagement of different types of complications. Aspecial interactive hot session on the second day of the

programme on ‘The obituary of myomamorcellation?’ included a two-houropen panel discussion led by eightspecialists in the field on the risks ofleiomyosarcoma dissemination with itsuse. In the end, it was agreed that ajoint ESGE-ESHRE statement on thisissue would be released soon.

Meanwhile, the current consensus of thegroup appeared to be that there remains a role forlaparoscopic myoma morcellation providing thatappropriate risk stratification, patient selection andcomprehensive counselling takes place.

Future eventsThis Campus meeting will be suitably followed up byour precongress course in Lisbon on Challengingreproductive surgery. Lectures will cover the everpopular topics of large myomas, massive cysts, severeAsherman’s syndrome and deep endometriosis. Theaudience can expect several hours of interestingimages and videos from renowned lecturers. Inaddition there will be four sessions dedicated to casepresentations and open discussion with the audience,which promises much interesting debate.

Training and educationAfter a successful first year, the second round of ourESHRE certification programme for the PrimaryLevel of Reproductive Surgery and the Master LevelReproductive Surgery will be taking place in Lisbon.

Meanwhile, we are glad to announce that theECRES Websurg electronic platform will be going livesoon. This will allow online registration, as well as anevaluation of participants through their e-Logbookand through the uploading of surgical procedures forreviewer scoring and feedback.

Sotirios SaravelosJunior Deputy, SIG Reproductive Surgery

‘Challenges in reproductive surgery’ for Lisbon PCCSTEERING COMMITTEE

Tin-Chiu Li (HK), Co-ordinatorGrigoris Grimbizis (GR), DeputyAntoine Watrelot (FR), DeputySotirios Saravelos (HK), Junior DeputyVasilios Tanos (CY), Past Co-ordinator

Interactive livesurgery performed by

Rudi Campo,Stephan Gordts,Sylvie Gordts andPatrick Puttermansat the endoscopy

workshop In Leuven.

The third session of the ECRES certification programmefor reproductive endoscopic surgeons will take place duringthe Annual Meeting in Lisbon. This unique programmeprovides an opportunity to validate hysteroscopic andlaparoscopic skills and experience, to establish status, andto join an elite group of specialists.The objectives of the certification programme are to: To improve knowledge and skills in reproductiveendoscopic surgery To increase patient safety and reduce unnecessary cost To develop an educational curriculum on a long term

basis, which will help training centres structure theircourses according to a target audience and levelThe ESHRE certification for reproductive endoscopic

surgeons is a two-track qualification, at Primary level andMaster level. The online registrations for both tracks of thecertification programme are available until 22 May 2015(23.59 CET) or until the maximum number of participantshas been reached. One of the requirements for acceptancefor the exam in Lisbon is the ECRES Winners certificatethrough the Websurg platform, which can be accessed viawww.eshre.eu/ecres/10steps More information about the ECRES programme and theapplication procedure is available on our website atwww.eshre.eu/ecres.

Third year of ECRES certification in Lisbon



More than 200 andrology abstracts submitted forLisbon, with highlights in the main sessions

SIG ANDROLOGY

‘My term as Co-ordinator of theSIG Andrology is coming to an endand a new Co-ordinator will beelected in Lisbon. It has been anexciting responsibility, with manyinteresting insights, not least thatthe world of andrology ismultifaceted. In many Europeancountries the field is clinicallydominated, often by the specialty of urology. Inother countries it is running primarily under thebanners of dermatology, endocrinology, sexology,gynaecology or internal medicine. Only in a veryfew countries - especially in the Middle East - isandrology established as a self-standing clinicaland research discipline. In ESHRE andrology isperceived primarily as spermatology. Thus, withICSI the dominant ART treatment, one sperm peregg is considered enough, and the male partner isalmost reduced to his ability to provide a limitednumber of gametes.

Lisbon programmeOur pre-congress course in Munich was onTreating the man with evidence based medicine,giving attention to the general health andwellbeing of the male partner. I still consider thisan important priority and hope that ESHREcontinues to promote the health of the malepartner as an important goal.

After scoring more than 200 andrology abstractssubmitted to this year’s Annual Meeting, myimpression of the scientific status of andrology iscause for a little concern. The majority of studiescan best be regarded as observational, usuallyinvestigating sperm quality with a large array ofsystems and a number of exposures. Usually, thesestudies are retrospective analyses of a limitednumber of samples from an IVF setting, whosescientific validity is marginal, though conclusionsoften dramatic.

Despite my concerns, we still see outstandingand highly promising breakthroughs in our field -and Lisbon will bring us up-to-date with some ofthese exciting developments. Sperm enthusiastswill certainly enjoy our precongress course, titledKeep the sperm in mind when perfecting ART:news and perspectives in spermatology. Thisbasic course deals with many clinical andtranslational aspects of sperm features andfunctions relevant for assisted fertilisation. Basicaspects of sperm biology will be matched withnovel strategies for sperm analysis and an outlook

on procedures for in vitro spermproduction from pluripotent stemcells. A critical evaluation of tools andendpoints used for the evaluation ofsperm quality provides a useful guidefor all andrologists.

In the main programme severaltopics will provide exciting new

insights. Nils Jörgensen fromCopenhagen will consider one andrological topicwhich is of great concern to the public as well as toall of us. Is human semen quality deteriorating?His lecture is entitled Human semen quality inthe new millennium: prospective studies ofsemen quality in Europe and other countries.His concerns will be underlined in a symposiumon the ‘impact of environmental toxins onreproductive health’.

‘Risks and benefits of being male’ is asymposium on the sex-specific aspects of meioticfailures and why males on average die youngerthan females. RAMAN spectroscopy as a newnon-invasive approach to the analysis of spermquality and features of living sperm, eggs andembryos will highlight a new scenario for theandrologist in a session on ICSI and beyond.

I am sure that for the andrology-orientedresearcher and clinician Lisbon will prove afantastic opportunity for updates on scientificprogress, and that the presentations continue tocreate much enthusiasm in our field.

I also hope all SIG Andrology members join ourbusiness meeting on Sunday to learn more aboutour future plans and support those people whowill take over responsibilities.

Future eventsThose interested in sperm banking have animportant event in their calendar later this year.We have developed a Campus meeting incollaboration with other groups on Donor spermbanking: medical, socio-cultural, ethical andlegal considerations, which will take place inLeuven, Belgium, from 10-11 December 2015. Thesubject of sperm banking has created muchdiscussion among ART groups but also amongregulatory bodies, so this course is highly relevantand presents an update on sperm banking systemsand donor recruitment. The course will providemany insights but will also propose best practiceprocedures and guidance.

Stefan SchlattCo-ordinator SIG Andrology

Stefan Schlatt (DE), Co-ordinatorWillem Ombelet (BE), DeputyJackson Kirkman-Brown (GB), DeputyVictoria Sanchez (DE), Junior DeputySheena Lewis (GB) Past Co-ordinator

STEERING COMMITTEE

Most studiesinvestigations ofsperm quality.

Guidelines development group: From left standing, Christos Venetis (GR), NathalieVermeulen (ESHRE), Tewes Wischmann (DE), Chris Verhaak (NL), Eline Dancet(BE), Sofia Gameiro (GB, chair). Sitting, Marysa Emery (CH), Cora De Klerk(NL), Petra Thorn (DE), Jacky Boivin (GB), Uschi Van den Broeck (BE).



SIG PSYCHOLOGY & COUNSELLING3

New guidelinesThe ESHRE guidelines on Routinepsychosocial care in infertility andmedically assisted reproduction – Aguide for fertility staff is now completeand approved by ESHRE’s ExecutiveCommittee. The guidelines will bemade available online on the ESHREwebsite and a summary of thisdocument has been submitted for publication toHuman Reproduction. These are the first everevidence-based psychology and counselling guidelineswithin the infertility field. They offer best practiceadvice to all fertility clinic staff (doctors, nurses,midwives, counsellors, social workers, psychologists,embryologists, and administrative personnel) on howto incorporate psychosocial care into routine infertilitycare.

We would like to express our sincere thanks to SofiaGameiro, chair of the guideline development group,Nathalie Vermeulen, ESHRE’s guideline expert, and tomembers of the guideline development group for theircontinuing effort and dedication to bring this excitingnew work to a good end. We hope the guidelines canmake a difference in clinical practice and we will keepyou updated on further efforts to implement theguidelines in daily practice.

Upcoming eventsOur next event on our SIG calendar is the AnnualMeeting in Lisbon where we will host a precongresscourse on Global (in)fertility: cross-cultural

challenges for counsellors. Many ofus are confronted in our clinical workwith practice and beliefs inreproductive medicine which varygreatly between cultures, countries andeven regions. This course will addressissues on the meaning of parenthoodin different cultures, with insight into

the experience of infertility in bothWestern and non-Western societies. What do weneed to know as counsellors and reproductivespecialists? What are the current and futurechallenges as ART becomes increasingly global?

Late September 2015 (24-25th) will bring the SIG toLeuven, Belgium, for a collaborative Campusworkshop with the SIG Endometriosis on Sexualfunctioning in women dealing with infertilityand/or endometriosis. This workshop aims toprovide an in-depth update on the interrelationshipbetween sexual function, infertility andendometriosis. Though sexuality and reproductionare intrinsically linked and sexual function can beaffected in patients with endometriosis, sexualfunction and sexual health remain difficult discussiontopics in clinical practice.

Leuven will also be hosting another Campus eventin December (11-12th) that will focus on donorsperm banking. The field of third party reproductionis ever-changing and this workshop will bringtogether medical, socio-cultural, ethical and legalconsiderations. The second day of the workshop willprovide more in-depth issues concerning third partycounselling. More detailed information on the coursecan be found on the ESHRE website:(http://new.eshre.eu/Calendar.aspx).

Steering Committee changesPlease mark your agendas with our business meetingin Lisbon which will take place at 5 pm after Sunday’spre-congress course. This is the time when we willannounce the new Steering Committee and thecurrent Co-ordinator will step down. This is also theplace to discuss your ideas concerning our SIG and tomeet the current and new Committee members.We are always open to suggestions concerningeducational opportunities or exciting new research topresent at annual meetings and value our members’input. So please let us know what we can do for you!We hope to see many of you in Lisbon soon.

Uschi Van den BroeckCo-ordinator SIG Psychology and Counselling

The first ever evidence-based guidelines onpsychosocial care in infertility

STEERING COMMITTEEUschi Van den Broeck (BE), Co-ordinatorCora de Klerk (NL), DeputySofia Gameiro (GB), DeputyMariana Martins (PT), Junior DeputyChristianne Verhaak (NL), Past Co-ordinator

Guidelines development group: From left standing, Christos Venetis (GR), NathalieVermeulen (ESHRE), Tewes Wischmann (DE), Chris Verhaak (NL), Eline Dancet(BE), Sofia Gameiro (GB, chair). Sitting, Marysa Emery (CH), Cora De Klerk(NL), Petra Thorn (DE), Jacky Boivin (GB), Uschi Van den Broeck (BE).


LAST WORD

I’m wondering if our fertility nurses have dumpedtheir Dolce & Gabbana. Have embryologists (yes, menas well) sent their D&G for recycling? Indeed, have weall, standing shoulder to shoulder with Elton, risen upin protest at the Italian designers’ description of IVFbabies as ‘synthetic’.

Domenico Dolce had told an Italian magazine: ‘ . . .what I call children of chemistry don’t convince me,synthetic children. Wombs for hire, [semen chosen]from a catalogue. And then you have to explain to thischild who is the mother. To procreate ought to be anact of love.’

Elton John, who has two surrogate children with hispartner David Furnish, was furious, and on hisInstagram account retorted: ‘How dare you refer to mybeautiful children as “synthetic”. And shame on youfor wagging your judgemental little fingers at IVF - amiracle that has allowed legions of loving people, bothstraight and gay, to fulfil their dream of havingchildren. Your archaic thinking is out of step with thetimes, just like your fashions. I shall never wear Dolceand Gabbana ever again. #BoycottDolceGabbana.’

Within minutes of the outburst, people had joinedthe protest and were posting pictures of their IVFbabies in support of Elton. Tweeters included VictoriaBeckham (‘Sending love to Elton David Zachary Elijah& all the beautiful IVF babies’), and MartinaNavratilova (‘wow- I had no idea’). And within a fewdays around 50 protesters, some brandishingplacards, had joined the boycott call outside theDolce & Gabbana store in central London. ‘Theircomments are not only an attack on same-sex parents,’said one campaigner, ‘but on all parents who’ve hadchildren with the aid of fertility treatment,including thousands of heterosexual couples.’

As the stand-off overflowed into a mediabattle of principle (to boycott or not to boycott),Dolce appeared to temper his views somewhat -and the ever resourceful Daily Mail even founda quote from 2006 in which Stefano Gabbana,

SyntheticbabiesPublic attitudesto IVF are still not universally approving


gay like Elton John, voiced a totally different tune onART. ‘I want my own child, a biological child,- he hadtold asn Italian newspaper, ‘a fruit of my sperm,conceived through artificial insemination. . . ‘

It’s second nature for all of us working in or aroundIVF to assume its universal acceptance. Indeed, oneconclusion to emerge from our legislation andreimbursement survey reported on page 22 is an everincreasing regulatory homogeneity throughout Europe.The deconstruction of Italy’s restrictive Law 40 was, asBenagiano et al have implied, in response to legalchallenges brought by members of the public.1 Foreven in Italy, where in 2004 the Catholic church wasinstrumental in blocking the outcome of a nationalreferendum on Law 40, public attitude seems now tohave fallen largely in favour of IVF, despite theoutbursts of D&G. An interesting editorialcommentary in RBM Online on the Italian situationattributes this homogenisation of attitude (and ofclinical practice) to the levelling power of public will.2

Yet clearly there remain dissidents. The unsuccessful(but vocal) One Of Us campaign of 2014 to restrict EUfunding on stem cells was largely driven by pro-lifegroups. And it is still the same pro-lifers who offertoken condemnation of most legitimate developments

in IVF. Progress in Poland towards any legislation inIVF has been mainly thwarted by the public role ofthe Catholic church. Yet the Twitterers seem to findno offence in such ‘political’ attitudes, so why are

they shocked when similar sentiments are aired bycelebrity couturiers, however hauts they may be.

Simon BrownFocus on Reproduction

1. Benagiano G, Filippi V, Sgargi S, Gianaroli L. ItalianConstitutional Court removes the prohibition ongamete donation in Italy. Reprod Biomed Online 2014;29: 662-664. 2. Ahuja KK. Patient pressure: is the tide of cross-border reproductive care beginning to turn? ReprodBiomed Online 2015, Jan 27 [Epub ahead of print].

Elton John:#BoycottDolceGabbana


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European Society of Human Reproduction and Embryology

Lisbon – Portugal14 to 17 June 2015

31ST ANNUAL MEETING

www.eshre2015.eu


www.eshre.eu


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