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AAGLAdvancing Minimally Invasive Gynecology Worldwide

Plenary 6 – Reproductive Issues

MODERATORS

G. David Adamson, MD & Patrick P. Yeung, MD

Christopher Allphin, MDHerve Fernandez, MD

Perrine Capmas, MDAnna Lyapis, MD

Caterina Exacoustos, MDRosa M. Neme, MD, PhD

Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Fertility Outcome after Laparoscopic Segmental Bowel Resection for Endometriosis R.M. Neme ................................................................................................................................................... 3 Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for Assessment of Tubal Patency A. Lyapis ....................................................................................................................................................... 6 Ectopic Pregnancy: A Prospective Cohort on Conservative Surgical Management with Systematic Postoperative Injection of Methotrexate P. Capmas ..................................................................................................................................................... 9 The Efficacy and Cost Effectiveness of a Combined Laparoscopic and Hysteroscopic Approach in the Treatment of Female Infertility C. Allphin .................................................................................................................................................... 11 Proximal Occlusion of Hydrosalpinges by Essure® before In Vitro Fertilization: A French Survey Herve Fernandez .............................................................................................................................. 15 Three‐Dimensional Sonographic Assessment of Tubal Patency with Gel Foam: Hysterosalpingo‐Foam Sonography C. Exacoustos ............................................................................................................................................. 17 Cultural and Linguistics Competency ......................................................................................................... 21

Plenary 6 – Reproductive Issues

Moderators: G. David Adamson and Patrick Yeung Faculty: Christopher Allphin, Perrine Capmas, Caterina Exacoustos, Herve Fernandez,

Anna Lyapis, Rosa M. Neme This session provides some of the latest data on issues important for fertility and reproduction, including: imaging modalities and techniques of evaluation of female anatomy – particularly the fallopian tubes, and of the effect of bowel resection and reanastomosis on fertility. There is an on-going search for less invasive ways to evaluate the female reproductive anatomy, and the impact of bowel resection on fertility (separate from pain) is not well documented, and the need for methotrexate after salpingectomy for ectopic pregnancy is not well characterized. Innovative techniques, and the latest studies address these issues. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Discuss the latest minimally invasive techniques to image and evaluate the fallopian tubes; 2) discuss the impact on bowel resection and reanastomosis for DIE on fertility; and 3) discuss the impact of postoperative methotrexate after salpingectomy for ectopic pregnancy.

Course Outline 12:05 Fertility Outcome after Laparoscopic Segmental Bowel Resection for Endometriosis R.M. Neme

12:15 Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for Assessment of Tubal Patency A. Lyapis

12:25 Ectopic Pregnancy: A Prospective Cohort on Conservative Surgical Management with Systematic Postoperative Injection of Methotrexate P. Capmas

12:35 The Efficacy and Cost Effectiveness of a Combined Laparoscopic and Hysteroscopic Approach in the Treatment of Female Infertility C. Allphin

12:45 Proximal Occlusion of Hydrosalpinges by Essure® before In Vitro Fertilization: A French Survey H. Fernandez

12:55 Three-Dimensional Sonographic Assessment of Tubal Patency with Gel Foam: Hysterosalpingo-Foam Sonography C. Exacoustos All Faculty

1:05 Closing Remarks/Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi*

SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). G. David Adamson Grants/Research: Auxogyn Christopher Allphin* Perrine Capmas* Caterina Exacoustos* Herve Fernandez* Ama Lyapis* Rosa M. Neme* Patrick P. Yeung Consultant: Lumenis Asterisk (*) denotes no financial relationships to disclose.

Fertility outcome after laparoscopic segmental bowel resection for endometriosis approach

Dr Rosa Maria Neme, MD, PhDUniversity of Sao Paulo, Brazil

2013

Disclosure

I have no financial relationships to disclose.

• Bowel endometriosis is the most severe forms of the disease that accounts

for 3,8 to 37% of women with endometriosis‐ rectum and rectosigmoid ‐

70% to 93%

• Infertility, chronic pelvic pain, pain at defecation, and altered quality of life

• Infertility >40% of women‐ anatomical abnormalities of genital organs,

functional alterations of peritoneal enviroment

• Several studies have confirmed the feasibility of colorectal ressection for

endometriosis and its efficiency to relief symptoms and improve fertility

rates of up to 50%

Introduction

• Surgery ‐ considered the first line treatment of choice

• In the 1990s ‐ pregnancy rates of up to 50% after laparotomic resection of

colorectal endometriosis

• 45.5% pregnancy rate among 22 women wishing to conceive after

laparoscopic colorectal resection for bowel endometriosis, with 75% of the

pregnancies obtained spontaneously

Introduction

Darai, 2005

Coronado, 1990

Evaluate fertility and pregnancy outcomes after

laparoscopic segmental bowel ressection in women with

symptomatic endometriosis

Objective • From July 2009 to July 2012 – Prospective study

• 250 women submitted to segmental bowel resection for endometriosis

referred to private clinic

• 92% had bowel symptoms as pain during evacuation, diarrhea,

constipation, abdominal bloating, and/or dyschezia

• 62% had an associated infertility

Material and Methods

3

• Diagnosis: clinical examination and transvaginal sonography with bowel

preparation


Endometriosis evolving at least the internal

muscularis of the rectum

•Mean age – 32.3 years (range 24–41 years)

•Mean BMI ‐ 23 (range 18‐35)

•Median duration of infertility before surgery was 18 months (range, 12–30

months)

•78% (121 women) underwent some infertility treatment (IUI or IVF) before

surgery

•18% had an associated male infertility


•Previous pelvic surgery – 69 %

•Symptom: dysmenorrhoea, non‐menstrual pelvic pain and dyspareunia,

diarrhea and/or constipation, pain on bowel movement, intestinal cramping,

pain on defecation, tenesmus and cyclic rectal bleeding, lower back pain and

asthaenia


Surgical Technique

Results

•Mean operative time ‐117 minutes (range 80‐190)

•SURGERY

•96 (62%) pregnancies were obtained

• 71 spontaneous (74%) and 25 by IVF (26%)

•Median time to conceive was 8 months. Four patients had miscarriage.

•No blood transfusion

•None intra‐operative or post‐operative complications

•Length of stay ‐ 3 days

•Extensive ureterolysis (80 %)

•Ovarian cystectomy (70 %)

•Torus resection (100%)

•US ligament (10 %/ 80 %)

•Partial vaginal resection (20 %)

•Appendectomy (20 %)

Evolution of symptoms and quality of life

•Mean follow‐up ‐ 6 months

•Symptoms : dysmenorrhoea, dyspareunia and pain on defecation, intestinal

cramping, diarrhea or constipation disappeared in all women after colorectal

resection

4

Histology

Stromal and glandular endometriosis

Conclusion

• Segmental laparoscopic bowel ressection for endometriosis

in symptomatic women with associated infertility is feasible

effective and safe and offers high pregnancy rates

[email protected]

5

Accuracy of Hysteroscopic Versus Laparoscopic Chromopertubation for

Assessment of Tubal Patency

Anna Lyapis, MDDanielle Luciano, MDAnthony Luciano, MD

The Hospital of Central Connecticut in affiliation with University of Connecticut

November, 2013

DISCLOSURE


OBJECTIVES

• Review literature on evaluation of tubal patency

• Demonstrate the technique of hysteroscopicchromopertubation

• Describe our study design

• Evaluate accuracy data

– Hysteroscopic versus laparoscopic assessment

LITERATURE REVIEW

Laparoscopy HSG HYCOSY Hysteroscopy

Sensitivity 75‐96% 67‐96% 72‐88% 83%

Specificity 67‐100% 71‐94% 68‐89% 82%

PPV 72‐94% 50‐92% 70‐94% 88%

NPV 50‐96% 83‐96% 56‐76% 77%

•Exacoustos et al JAAGL 10(3):367-72, 2003.•Degenhardt et al: Clin Radiol 51(1):15-18, 1996.•Reis MM et al. Hum Reprod 13(11):3049-52, 1998.•Dijkman AB et al. Eur J of Radiol 35:44-8, 2000.•Tamasi F et al.. J Ob Gynecol 121:186-90, 2005.•Adelusi B et al. Fer Steril 63(5):1016-20, 1995. •Torok P et al. J of Min Invasive Gynecol 19(5):627-30, 2012•Luciano D et al. Am J Obstet Gynecol 204(1):79, 2011

HYSTEROSCOPIC CHROMOPERTUBATIONHYSTEROSCOPIC

CHROMOPERTUBATION

PATENT TUBE OCCLUDED TUBE

6

STUDY DESIGN

• Prospective analysis

• 54 patients undergoing concomitant hysteroscopy and laparoscopy

• March 2012 through March 2013

• Exclusion:– Age < 18 years old

– Malignant condition

– Pregnancy

– Active Pelvic Inflammatory Disease

RESULTS

108 tubes evaluated108 tubes evaluated

99 tubes evaluated by

hysteroscopy and laparoscopy

99 tubes evaluated by

hysteroscopy and laparoscopy

91 Concordant91 Concordant

82 tubes patent on both

82 tubes patent on both

9 occluded on both9 occluded on both

8 Discordant8 Discordant

5 patent on hysteroscopy but occluded on laparoscopy

5 patent on hysteroscopy but occluded on laparoscopy

3 occluded on hysteroscopy but

patent on laparoscopy

3 occluded on hysteroscopy but

patent on laparoscopy

9 tubes not visualized9 tubes not visualized

RESULTS

+ Test (occluded on Hysteroscopy)

‐ Test (patent on hysteroscopy)

+ Disease (tube occluded on Laparoscopy)

9 3

‐ Disease (tube patent on Laparoscopy)

5 82

a b

dc

Sensitivity: a/(a+c) 9/14 = 64.3%Specificity: d/(d+b) 82/85 = 96.5%Positive predictive value: a/(a+b) 9/12 = 75.0%Negative predictive value: d/(d+c) 82/87 = 94.3%

How Do Our Results Compare?

Laparoscopy HSG HYCOSY Hysteroscopy Our Study

Sensitivity 75‐96% 67‐96% 72‐88% 83% 64.3%

Specificity 67‐100% 71‐94% 68‐89% 82% 96.5%

PPV 72‐94% 50‐92% 70‐94% 88% 75.0%

NPV 50‐96% 83‐96% 56‐76% 77% 94.3%

•Exacoustos et al JAAGL 10(3):367-72, 2003.•Degenhardt et al: Clin Radiol 51(1):15-18, 1996.•Reis MM et al. Hum Reprod 13(11):3049-52, 1998.•Dijkman AB et al. Eur J of Radiol 35:44-8, 2000.•Tamasi F et al.. J Ob Gynecol 121:186-90, 2005.•Adelusi B et al. Fer Steril 63(5):1016-20, 1995. •Torok P et al. J of Min Invasive Gynecol 19(5):627-30, 2012•Luciano D et al. Am J Obstet Gynecol 204(1):79, 2011

CONCLUSIONS

• Hysteroscopic chromopertubation has poor sensitivity

• By using this test, we would call an occluded tube “patent” in 35.7%

• Hysteroscopic chromopertubation has excellent specificity

• By using this test, we would call a patent tube “occluded” in 3.5%

REFERENCES

• Exacoustos et al JAAGL 10(3):367‐72, 2003.

• Degenhardt et al: Clin Radiol 51(1):15‐18, 1996.

• Reis MM et al. Hum Reprod 13(11):3049‐52, 1998.

• Dijkman AB et al. Eur J of Radiol 35:44‐8, 2000.

• Tamasi F et al.. J Ob Gynecol 121:186‐90, 2005.

• Adelusi B et al. Fer Steril 63(5):1016‐20, 1995.

• Torok P et al. J of Min Invasive Gynecol 19(5):627‐30, 2012

• Luciano D et al. Am J Obstet Gynecol 204(1):79, 2011

7

QUESTIONS

THANK YOU!

8

ECTOPIC PREGNANCY: a prospective cohort on conservative surgical management with systemic

postoperative injection of methotrexate

Perrine CAPMAS (MD)

Bicetre hospital ‐ France

Disclosure

• No financial relashionships to disclose.

ECTOPIC PREGNANCY: a prospective cohortP. CAPMAS – AAGL 2013

Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Objectives

• Report failure of conservative surgery

= SALPINGECTOMY RATE

• Report failure of surgery

=PERSISTENT TROPHOBLAST


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Methods

• Prospective data from a randomized trial

• Conservative surgery withpostoperative injection of methotrexate (1mg/kg)

• Statistic:– Student’s test

– Chi2 test

– Logistic regression model


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Ectopicpregnancy

ACTIVE ECTOPIC PREGNANCYFernandez score ≥ 13 Suspicion of tubal rupture

Randomisation Randomisation

Medicalmanagement(Methotrexate)

Radicalsurgery

CONSERVATIVESURGERYwitha

postoperativeinjectionofMethotrexate

LESS ACTIVE ECTOPIC PREGNANCY

Fernandez score < 13 No suspicion of tubal rupture


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Results

• 196 women

– 96 with less active EP

– 100 with active EP

• Initial salpingectomy rate=15%

• Persistent trophoblast=0.6% [0‐1.8%]


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

9

Flow chart196 women

with ectopic pregnancy

166 women withconservative surgery

141 (85%) with conservative surgery and systematic injection

of MTX

1 failure (0.7%)

25 (15%) with no injection of MTX

No failure

Radical surgery: n=30 (15%)


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Salpingectomy rate

• 15%

• Less active pregnancy=9%

• Active ectopic pregnancy=21%

p=0.02


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Discussion

• Initial failure of conservative surgery

– First time reported in an important population

– Very high

– Depending on activity of ectopicpregnancy (HCG – progesterone)


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Discussion

• Low rate of persistent trophoblast after postoperativemethotrexate injection isconfirm in current practice

• As in randomized trial

• Interesting when persistent trophoblast is more than 7%


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Conclusion

• Women has to be inform of the high risk of radical surgery evenwhen a conservative surgery us decided

• Postoperative injection of methotrexate is confirmed to avoid persistent trophoblast


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

Bibliography

1. Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J. Fertility after ectopic pregnancy: the DEMETER randomizedtrial. Human Reprod 2013;28:1247‐1253.

2. Graczykowski JW, Mishell JR. Methotrexate prophylaxis for persistent ectopic pregnancy after conservative treatment by salpingostomy. Obstet Gynecol 1997;89:118‐122.

3. Akira S, Negishi Y, Abe T, Ichikawa M, Takeshita T. Prophylacticintratubal injection of methotrexate after linear salpingostomyfor prevention of persistent ectopic pregnancy. J ObstetGynaecol Res 2008;34:885‐889.

4. Gracia CR, Brown HA, Barnhart KT. Prophylactic methotrexateafter linear salpingostomy: a decision analysis. Fertil Steril2001;76:1191‐1195.

5. Sowter MC, Farquhar CM, Petrie KJ, Gudex G. A randomised trial comparing single dose systemic methotrexate and laparoscopicsurgery for the treatment of unruptured tubal pregnancy. BJOG 2001;108:192‐203.


Disclosure

Objectives

Methods

Results

Flow chart

Salpingectomy rate

Discussion

Conclusion

Bibliography

10

Chris Allphin MD


Minimally invasive gynecologic surgery (MIGS) involves vaginal surgery, laparoscopy and hysteroscopy

Involves small or no incisions Continuing to define the role for MIGS in all

facets of an Ob/Gyn practice

Laparoscopy and Hysteroscopy at the same operating room visit

Performed by two different surgeons at the same time

Treatment of patients with uterine pathology such as leiomyomata or septa

Benefits Diagnose and treat

uterine pathology inside and outside the uterus

Often Only one procedure needed

???

11

Is there a role for MIGS, specifically the dual procedure, in a sub-fertile population seeking pregnancy?

Hypothesis: The dual procedure will diagnose and treat uterine pathology helping women achieve pregnancy with similar rates to a fertile population

Cost analyses: The dual procedure will cost less than if the procedures were done at separate O.R. admissions

Patients that had the dual procedure from 2007-2012 at a MIGS clinic

Narrowed down to only patients referred to the MIGS clinic from fertility specialists

All the patients had a complete fertility workup and had abnormal findings on ultrasound

30 patients were found that met the criteria since 2007.

23 chart reviews were completed between the infertility offices and the electronic medical record.

The remaining 7 patients were contacted by telephone and asked about pregnancy results before and after the procedure.

13 patients had a septum and 17 patients had leiomyomata

Pathology Procedure

Septum Hysteroscopic metroplastywith diagnostic laparoscopy

Leiomyomata Diagnostic laparoscopy with hysteroscopic and/or laparoscopic myomectomy

21/30 (70%) patients were able to achieve pregnancy

Live birth rate of 54% (17/30) Miscarriage rate of 17% (5/30) 21 live births, 2 sets of twins 5 patients were able to conceive twice

14 spontaneous pregnancies including one twin pregnancy

4 IUI pregnancies 7 IVF pregnancies

12

Age range (n) Pregnancy Rate

<35 (13) 82%

35-40 (9) 62.5%

Age > 40 (8) 60%

Pathology Procedure Pregnancy rate

Septum Hysteroscopicmetroplasty with diagnostic laparoscopy

84.6% (11/13 pts)

Leiomyomata Hysteroscopic and laparoscopic myomectomy

58.8% (10/17 pts)

Procedure Average cost

Laparoscopy and hysteroscopy at different admissions

$38,256.70

Dual procedure,one admission

$23,185.34

Average of $15,000 saved per every patient that had the dual procedure at the same visit.

30 patients saved the system $450,000.

2 patients had no antral follicles at the return to the fertility specialist

2 patients attempted one cycle of IVF then discontinued therapy

3 patients continue to go through IVF cycles 1 patient has postponed attempting conception

until finishes her masters 1 patient discontinued after 2 cycles of IUI.

MIGS, specifically hysteroscopy and laparoscopy, is an excellent tool to offer to patients with infertility for diagnosis and treatment of uterine pathology

After treatment, many of these patients can achieve pregnancy spontaneously without the use of assisted reproductive technology (ART)

Significant cost savings are achieved if the procedures are done at the same time

Retrospective case review Low number of patients No standardization of follow up time

13

Proximal occlusion of hydrosalpinges by Essure® before assisted reproduction

techniques: a French survey.

Service de Gynécologie‐Obstétrique, Assistance publique des hôpitaux de Paris‐ Hôpital de Bicêtre78 rue du général Leclerc,

94275 Le Kremlin‐Bicêtre, France

Hervé FERNANDEZ

Disclosure


Introduction

• Hydrosalpinx halves the pregnancy rate after IVF of women with tubal infertility– Zeyneloglu HB & al., Fertil Steril 1998. – Camus E & al. Hum Reprod 1999.

• Numerous authors have demonstrated that salpingectomy can correct this effect by increasing the likelihood of clinical pregnancy – Strandell A & al. Hum Reprod 2000. – Déchaud H& al.Fertil Steril 1998. – Johnson N & al. Cochrane Database Syst. Rev. Online. 2010;– Kontoravdis A, Fertil Steril 2006– Moshin V & al.Hum Reprod 2006

Introduction (2)

• Proximal tubal occlusion by laparoscopy has an effect similar to that of salpingectomy– Kontoravdis A & al. Fertil Steril 2006

– Moshin V & al. Hum Reprod 2006

• The surgical risk during laparoscopy, especially for women with major pelvic adhesions, has led some surgeons to use Essure® for hysteroscopictubal occlusion, an off‐label use different from its primary purpose of tubal sterilization.

Study Objectives

• To study the feasibility and results (live‐birth and complication rates) of the placement of Essure® microinserts before assisted reproduction technology (ART) treatment of women with hydrosalpinx.

Material and methods

• National survey of 45 French hospital centers providing ART treatment, with a retrospective analysis of all women with unilateral or bilateral hydrosalpinges.

15

Results

• Of the 45 centers contacted, 7 centers responded that they had performed such procedures, and 23 that they had not, for an overall response rate of 66.6% (30/45). Fifteen centers did not respond, despite four reminders.

Results (2)

• The placement success rate reached 92.8% (65/70 tubes), and the mean number of visible intrauterine coils was 1.61 (range: 0 to 6).

• Pyosalpinx occurred in one case, and expulsion of the device into the uterus in two others.

• Of 43 women, 29 (67.4%) had a total of 54 fresh or frozen embryos transferred.

• The clinical pregnancy rate was 40.7% (22/54) and the live‐birth rate 25.9% (14/54).

• The implantation rate was 29.3% (27/92).

Results

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

Tx implantation Tx grossesse clinique*** Tx FCS** Tx naissance vivante***

29,3%(27/92)

40,7%(22/54)

31,8%(7/22)

25,9%(14/54)

Implantation rate (%, n per embryo transferred)

Clinical pregnancy rate per embryo transfer (%)

Spontaneous abortion (%, n per clinical pregnancy)

Live‐birth rate per transfer (%)

Conclusion

• Use of the Essure® system is an effective method for occlusion of hydrosalpinges. The live‐birth rate after embryo transfer makes it the method of choice when laparoscopy should be avoided, with rates similar to those for salpingectomy or tubal ligation.

Bibliography

– Zeyneloglu HB, Arici A, Olive DL. Adverse effects of hydrosalpinx on pregnancy rates after in vitro fertilization‐embryo transfer. Fertil Steril 1998;70(3):492‐499.

– Camus E, Poncelet C, Goffinet F, Wainer B, Merlet F, Nisand I, et al. Pregnancy rates after in‐vitro fertilization in cases of tubal infertility with and without hydrosalpinx: a meta‐analysis of published comparative studies. Hum Reprod 1999;14(5):1243‐1249.

– Strandell A, Lindhard A. Hydrosalpinx and ART. Salpingectomy prior to IVF can be recommended to a well‐defined subgroup of patients. Hum Reprod 2000;15(10):2072‐2074.

– Déchaud H, Daurès JP, Arnal F, Humeau C, Hédon B. Does previous salpingectomy improve implantation and pregnancy rates in patients with severe tubal factor infertility who are undergoing in vitro fertilization? A pilot prospective randomized study. Fertil Steril1998;69(6):1020‐1025.

– Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BWJ. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst. Rev. Online. 2010;(1):CD002125.

– Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril 2006;86(6):1642‐1649.

– Moshin V, Hotineanu A. Reproductive outcome of the proximal tubal occlusion prior to IVF in patients with hydrosalpinx. Hum Reprod 2006;21:i193‐i194.

– Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril 2006;86(6):1642‐1649.

16

Three dimensional sonographic assessment of

tubal patency with gel foam:

Hysterosalpingo-foam sonography HyFoSy

Caterina Exacoustos MD,

Università degli Studi di Roma ‘Tor Vergata’Department of Biomedicine and Prevention

Obstetrics and Gynecology

Università degli Studi di SienaDepartment of Molecular and Developmental Medicine

Obstetrics and GynecologyITALY

Disclosure


HyCoSy with air+saline benefits:

Reproducible and simple technique Office procedure Used in combination with ultrasound imaging Less need for radiology No esposure to ionizing radiation No anesthesia required Low economic costs Reduced discomfort for patient Well tolerated by patients No adverse reactions to contrast ‘Real time’ diagnosis of tubal patency Accuracy is similar to HSG

Signals from the total length of the tube has rarely been depicted in a single scanning plan because of tubal tortuosity

Need of skill examiner: To see tubal course

To mentally reconstruct an image of the tube from partial visualization

To repeat manipulation of the transducer and injection of saline to obtain tubal course visualization

HyCoSy limitations and difficulties encountered with conventional 2D TVS with

air+saline or with ultrasound dedicated contrast media :

to assess the feasibility of threedimensional (3D) hystero-salpingo-contrast-sonography (TVS HyCoSy) withgel foam (HyFoSy) in the evaluation oftubal patency and visualization of tubalcourse.

Aim of the study 144 patients undergoing TVS HyFoSy12 with hysteroscopic tubal sterilization• at least after 3 months of ESSURE application• during the proliferative phase of the cycle(day 5-12) or at any

time of the cycle if on OC• informed written consent was obtained from all patients

132 infertile patients• during the proliferative phase of the cycle (day 5-12).• informed written consent was obtained from all patients

All underwent • Evaluation of the reproductive history• 2D and 3D TVS scan (Voluson E6 ultrasound machine (GE Healthcare, Zipf, Austria)

• TVS HyFoSy with 3D and 2D and gel foam as ultrasound contrast agent• Evaluation of feasybility of the method• Evaluation of pain during and after the procedure

Study population

17

MethodsTo evaluate the feasibility of the method we

considered: visualisation with 3D TVS of tubal patency or occlusion at two

consecutive injections of gel foam;

visualisation of the gel foam around the ovaries;

final results of tubal patency after detection in 2D TVS

realtime of the foam bubbles movement in the tube and around

the ovaries;

pain during and after the procedure (0-10 VAS scale);

other side effects (vagal reactions, need of analgesic drugs).

Methods• 3D HyFoSy TVS volume acquisition was

performed :– during the first injection of 4-6ml gel foam– during the following second injection of 4-6ml gel

foam • 2D realtime TVS was performed during

further injection of gel foam to detect foam and bubbles movements- in the tubes- around the ovaries

Sterile gel(hydroxyethylcellulose, glycerol and purified water) ( ExEm® gel, Farco-Pharma GmbH, Köln, Germany)LABLEUSA- ExEm gel is FDA approved for uterine intracavity ultrasound imaging and gel infusion sonography (GIS), ExEm Foam for HyCoSy is not yet FDA approvedEUROPE-ExEm gel and ExEm Foam are both CE marked, on lable for GIS and HycoSy

• 5ml of sterile gel+10ml purified water or saline+3-5ml of air by mixing sterile gel and purified water or saline a gel foam is created.

• 5 fr HyCoSy balloon catheter

HyCoSy with Gel Foam =HyFoSy

3D2D

Results132 infertile patients

72 had primary infertility

60 had secondary infertility

Mean age : 36.8 yrs (24-44)

Gravidity : 0.71 (0 - 5)Parity: 0.24 (0-2)BMI: 21.9 (16.0 - 27.9� )

12 with hysteroscopictubal sterilization

Mean age : 41.6 yrs (34-49)

Gravidity : 2.25 (0 - 4)Parity: 1.75 (0-3)BMI: 22.5 (17.7 - 25.9� )

132 infertile patients

88 bilateral patency 8 bilateral occl. 36 unilateral occl.

3D HyFoSyfirst injection

3D HyFoSysecond inject.


3 14 2


2D HyCoSy real time futher inject.

1 3

18

HyFoSy in 132 INFERTILE patients (263 tubes*) Tubal patency status

first 3D volume

acquisition

second 3D volume

acquisition

Final results after 2D realtime

Bilaterally patent nr pts (%) 88 105 108

Bilaterally occluded nr pts (%) 8 3 2

Unilaterally occluded nr pts(%) 36 24 22

Concordance rate to final 2D real-time results

112 (84.8%) 129 (97.7%) 132

Patent tubes nr tubes (%) 211 234 238

Occluded tubes nr tubes (%) 52 29 25


236 (89.7%) 259 (98.4%) 263

ResultsCONCORDANCE RATE

• 1 patients with unicorne uterus• Salpingectomy for ectopic was considered as present-occluded tube

12 patients with hysteroscopic

tubal sterilization

0 bilateral patency 11 bilateral occl. 1 unilateral occlusion

3D HyFoSyfirst injection

3D HyFoSysecond inject.


1


2D HyCoSyreal time

futher inject.

HyFoSy in 12 patients hysteroscopic tubal sterilisation (24 tubes)

Tubal patency status

first 3D volume

acquisition

second 3D volume

acquisition

Final results after 2D real-time

Bilaterally patent nr pts (%) 0 0 0

Bilaterally occluded nr pts (%) 11 10 10

Unilaterally occluded nr pts(%) 1 2 2


11 (91.6%) 12 (100%) 12

Patent tubes nr tubes (%) 1 2 2

Occluded tubes nr tubes (%) 23 22 22


23 (95.8%) 24 (100%) 24

ResultsCONCORDANCE RATE

PAIN (VAS 0-10) 132 infertile pts

mean score nr pts (%)

12 pts tubal sterilization

mean score nr pts (%)

DURING HyFoSy 6.3 ± 1.9 4.4 ± 2.8AFTER HyFoSy 5.1 ± 2.5 0.9 ± 1.9*DURING and AFTER HyFoSy 5.7 ± 2.3 2.6 ± 3.1*Vagal reactions 1 (0.8%) 0 (0%)Analgesic drug administered 19 (14.4%) 0 (0%)

ResultsEVALUATION OF PAIN

After two 3D volume acquistion weobtained 97.8�% of final results fortubal patency

3% of tubes which results occluded arepatent after other injections

Pain at HyFoSy is less when tubes wereoccluded

ConclusionsMany disadvantages associated to 2D HyCoSy are

overcome by means of the 3D HyFoSy :automated 3D volume acquisition show the tubal course in the

space

echogenicity of the gel foam is visualized clearer and more persistent compared to air bubbles

the 3D volume acquisition during HyFoSy is static and avoids difficult probe movements and easier to perform also by less experienced of the operator

Low costs compared to dedicated ultrasound contrast media

volume can be stored and analyzed later reducing examinationtime

images are similar to HSG and pictures and volumes can beevaluated by other clinicians

Conclusions

19

References1. Boudghene FP, Bazot M, Robert Y, et al: Assessment of fallopian tube patency by HyCoSy: Comparison of a positive contrast agent with

saline solution. Ultrasound Obstet Gynecol 18:525–530, 20012. Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D Hysterosalpingo-Contrast Sonography Compared with

Hysterosalpingography and Laparoscopic Dye Pertubation to Evaluate Tubal Patency J Am Assoc Gynecol Laparosc 10(3): 29-32, 20033. Volpi E, Zuccaio G, Patriarca A, et al: Transvaginal sonographic tubal patency testing using air and saline solution as contrast media in

routine infertility clinic setting. Ultrasound Obstet Gynecol 7:43–48, 1996. 4. Dijkman AB, Ben WJ, Van der Veen F, et al: Can hysterosalpingocontrast- sonography replace hysterosalpingography in the assessment

of tubal subfertility? Eur J Radiol 35:44–48, 20005. Prefumo F, Serafini G, Martinoli C, Gandolfo N, Gandolfo NG , Derchi LE. The sonographic evaluation of tubal patency with stimulated

acoustic emission imaging. Ultrasound Obstet Gynecol 20: 386-389, 2002.6. Dietrich M, Suren A, Hinney B, Osmers R, Kuhn W. Evaluation of tubal patency by HysterocontrastSonography (HyCoSy, Echovist) and

its correlation with laparoscopic findings. J Clin Ultrasound 24: 523-527, 19967. Exacoustos C, Zupi E, Szabolcs B, Amoroso C, Di Giovanni A, Romanini ME, Arduini D. Contrast tuned imaging and second generation

contrast agent SonoVue: a new ultrasound approach to evaluate tubal patency. J Minim Invasive Gynecol 16: 437-444, 2009.8. Lanzani C, Savasi V, Leone FPG, Ratti M, Ferrazzi E. Two dimensional HyCoSy with contrast tuned imaging technology and a second

generation contrast media for the assessment of tubal patency in a infertility program. Fertil Steril 92: 1158-61, 20099. Luciano DE, Exacoustos C, Johns DA, Luciano AA. Can hysterosalpingo-contrast sonography replace hysterosalpingography in

confirming tubal blockage after hysteroscopic sterilization and in the evaluation of the uterus and tubes in infertile patients? Am J Obstet Gynecol 204: 79-84, 2011.

10. Exalto N, Stappers C, van Raamsdonk LAM, Emanuel MH. Gel Instillation Sonohysterography: first experience with a new technique. Fertil Steril 87:152-155, 2007.

11. Emanuel MH, Exalto N. Hysterosalpingo-foam sonography (HyFoSy): a new technique to visualize tubal patency. Ultrasound Obstet Gynecol 37: 498-9, 2011.

12. Emanuel MH, van Vliet M, Weber M, Exalto N. First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing. Hum Reprod. 27: 114-7, 2012.

13. Exacoustos C, Di Giovanni A, Szabolcs B, Binder-Reisinger H, Gabardi C, Arduini D. Automated sonographic tubal patency evaluation with three-dimensional coded contrast imaging (CCI) during hysterosalpingo-contrast sonography (HyCoSy).Ultrasound Obstet Gynecol 34: 609-612, 2009.

14. Exacoustos C, Di Giovanni A, Szabolcs B. Romeo V, Romanini ME, Luciano D, Zupi E, Arduini D. Automated three-dimensional coded contrast hysterosalpingo-contrast-sonography: feasibility in office tubal patency testing. Ultrasound Obstet Gynecol 41:328-35, 2013.

20

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

21

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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