IVF Egg Freeze Orientation Packet · 2019. 3. 7. · o IVF Procedure CPT Codes: 89280, 89281,...

Update 9/18

IVF ORIENTATION

The registration materials and questionnaires in this packet must be completed, signed, notarized (when

noted) and mailed back to the Center in the enclosed envelope, or faxed to 484-380-4866 if printed

online. All paperwork must be received by the Center prior to your appointment.

Your IVF Orientation is scheduled for ________________________________ @ ________________.

** Please provide at least 24 hours notice if you are unable to make the appointment. ** We apologize for any inconvenience, but we are unable to accommodate children at the orientation appointment.

• Please bring insurance card and photo ID for patient and spouse/partner.

• Appointment may take up to 1.5 hours and will include a semen analysis (unless donor sperm is to be used or surgical extraction of sperm is required) as well as an information session with an IVF nurse. You will NOT be meeting with your physician.

• As male patients are expected to produce a semen specimen for analysis, a 2-3 day abstinence period is recommended before orientation appointment. (This does not apply if donor sperm is to be used or surgical extraction of sperm is required.)

• It is the patient’s responsibility to check with their insurance company to see if IVF and IVF related test costs are covered.

o Semen analysis CPT codes: 89320 and 89261. o IVF Procedure CPT Codes: 89280, 89281, 89272, 89253, 89290, 89291, 58970, 58974, 89258,

89342, 89337

• If referrals are required by the insurance companies for the semen analysis, please call your PCP to have referral submitted before your orientation appointment. Your PCP will need the following information:

o Keystone: NPI# 1669434700 DX Code: N46.9 CPT Codes: 89320, 89261 o Aetna: NPI# 1669434700 DX Code: N46.9 CPT Codes: 89320, 89261

• Please provide the nurse with a copy of your most recent PAP smear results. Fax to 484-380-4866.

• If required lab work (bloods and urine) were not already drawn, you may be asked to go to your capitated lab to have them drawn after orientation. The results must be received BEFORE you are able to start any treatment.

• Please call Amy Brennan, IVF Financial Coordinator, for insurance coverage information and fee related questions at 484-380-4883. You will NOT be meeting with her on the day of orientation.

We look forward to meeting with you!

Bryn Mawr Medical Arts Pavilion / 825 Old Lancaster Road, Suite 170 / Bryn Mawr, PA 19010 / 484-380-4900 P / 484-380-4895 F

IVF Patient Contact Information

Patient Name: _____________________________________ Date of Birth: ______________

• Preferred Phone # _____________________________ Message OK? □ Yes □ No

• Secondary Phone # ____________________________ Message OK? □ Yes □ No

• Email Address ___________________________________________________________

• Comments: ______________________________________________________________

________________________________________________________________________□ I understand by answering yes to the questions above, I am authorizing Main Line Fertility to leave my protected

health information (including but not limited to results, prescriptions, and appointments) on the voicemail of the designated phone number(s).

Authorization to Disclose Protected Health Information: I hereby authorize the disclosure of my protected health information (including HIV/AIDS related information, if any) to the person (s) designated below.

Name: __________________________________________________ Relationship: ___________________ Name: __________________________________________________ Relationship: ___________________ □ If box is checked, I do not authorize my protected health information to be released to persons other than myself.

Signature __________________________________________________ Date: _________________________

………………………………………………………………………………………………………………………………………………

Partner Name: _____________________________________ Date of Birth: ______________

• Preferred Phone # _____________________________ Message OK? □ Yes □ No

• Secondary Phone # ____________________________ Message OK? □ Yes □ No

• Email Address ___________________________________________________________

• Comments: ______________________________________________________________

________________________________________________________________________□ I understand by answering yes to the questions above, I am authorizing Main Line Fertility to leave my protected

health information (including but not limited to results, prescriptions, and appointments) on the voicemail of the designated phone number(s).

Authorization to Disclose Protected Health Information: I hereby authorize the disclosure of my protected health information (including HIV/AIDS related information, if any) to the person (s) designated below.

Name: __________________________________________________ Relationship: ___________________ Name: __________________________________________________ Relationship: ___________________ □ If box is checked, I do not authorize my protected health information to be released to persons other than myself.

Signature __________________________________________________ Date: _________________________


Patient Name: _________________________________

Patient D.O.B.: ________________________________

*** IMPORTANT – PLEASE READ AND SIGN ***

Billing Information for IVF Bloods and Semen Analysis (if applicable)

General Main Line Fertility Center (MLFC) requires bloods to be drawn on all patients and partners. These bloods need to be

repeated annually for patients who continue to have IVF services at MLFC. MLFC also completes a comprehensive

semen analysis, if applicable, on or around the orientation day as well. Male patients may be required to have repeat

semen analysis and/or semen freezing services during the course of treatment at MLF.

Bloods Many patients having standard IVF bloods have complete or partial insurance coverage for these services. MLFC is not

able to determine exactly what, if any, coverage a patient will have for bloods. It is the patient’s responsibility to inform

MLFC which lab your insurance company dictates. MLFC has no control over these lab bills and will not be responsible

to pay these lab bills. MLFC has a list of necessary bloods available at a patient’s request.

Semen Specimens (if applicable) MLFC provides IVF semen analysis services. Testing may have to be repeated and a sperm freeze may be recommended.

Insurance companies may or may not pay for semen services. It is the patient’s responsibility to investigate insurance

coverage and the need for referrals. MLFC is not responsible for obtaining referrals. If the patient’s insurance company

does not pay for semen services, the patient will be responsible to pay the bill. MLFC has a list of semen analysis

services and costs.

Agreement: I am aware that my blood samples will be sent to an outside lab. I am aware that MLFC has no control over outside labs

and, if my insurance company does not pay for these tests for any reason, I will be responsible to pay the fees. I agree

to research my insurance coverage myself if I have concern about these fees. I am aware that insurance companies

make frequent changes in policies and coverage. MLFC makes an effort to follow these changes, but it is ultimately my

responsibility to research coverage completely and to advise MLFC if there are special instructions that my insurance

company provided.

I am aware that several semen tests (if applicable) are completed by IVF patients and that repeat testing and other

semen services may be required. All services have associated charges. I agree to research my insurance coverage and

provide any necessary referrals. I am aware that if my insurance company does not pay for services, I will be fully

responsible to pay.

By signing this form, I agree that I have reviewed this document. I understand that MLFC will not be responsible for

any unpaid semen analysis services or blood services.

I also agree that I am providing MLFC with current insurance information and that I will keep MLFC up-to-date with

any insurance changes that I may have during my course of treatment.

Patient Signature ________________________________________________ Date __________________________

Partner Signature ________________________________________________ Date __________________________


Patient Name: ______________________________

Patient D.O.B.:______________________________

Notifications

Patient Rights & Responsibilities:

I acknowledge that I have received, both verbally and in written format, the Main Line Fertility Center’s Patient’s Rights information. Furthermore, I have had the opportunity to read the notice, ask questions regarding my rights as a patient and understand all information as presented.

Financial Disclosure:

I am aware that my physician DOES / DOES NOT (circle one) have a financial and ownership interest in the Main Line Fertility

Center. I acknowledge that I have selected to have my procedure performed at the Center after considering both my

physician’s financial interest in the Center and my choice to have the procedure performed at a different facility.

Advanced Directives:

I acknowledge that I have been informed that an Advances Directive does not apply during the time of my procedure at Main

Line Fertility Center. I understand that all life saving measures will be taken during my procedure at the Center even if I have

fully executed Advanced Directive to the contrary.

If I do have an Advance Directive at the time of my admission to Main Line Fertility Center, and I provide a copy, it will be

placed in my records.

In the unlikely event that an emergency arises and I need to be transferred to a hospital for further care, my Advance Directive

will be sent to the receiving hospital.

By my signature below, I acknowledge that I have received the aforementioned notices provided by the Main Line Fertility

Center prior to the date of my procedure, or if my procedure has been scheduled the same day as my referral, I have

received the notices prior to the Center obtaining informed consent for the procedure.

Patient Signature: ____________________________________________

Date: ______________________________________________________

Time: ______________________________________________________ (Complete time only if receiving notice on the same day as referral for the procedure.)


Patient Name: ______________________________

Patient D.O.B.:______________________________

Patient Informed Consent / Decline for Carrier Screening

1. Purpose: I understand that one or more tests are being ordered by my physician to determine if I am a carrier

for one or more of the following genetic conditions, including but not limited to: alpha-thalassemia, beta-

thalassemia, cystic fibrosis, fragile X syndrome, sickle cell anemia, spinal muscular atrophy, Tay-Sachs disease.

Additional panels may be added if I identify myself as a specific ethnicity.

2. Methods: Testing is performed on a small sample of blood. Accurate information about my family history and

ethnic background is required for an accurate interpretation of the test results.

3. Results: I understand that if the test results are positive, I may be a carrier of the disorder tested. I may also

learn that I have an undiagnosed disorder, or that I am at an increased risk for a different disorder caused by

mutations in one of the genes tested. If test results are negative, my risk to be a carrier of, or to have the

disorder tested, is reduced but not eliminated.

4. Risks and limitations: The test results may not provide definitive conclusions regarding reproductive risk. While

this testing is highly accurate, rare testing errors may occur. Accurate results may not be obtained for reasons

including but not limited to sample mix-up, bone marrow transplant, recent blood transfusion, or technical

problems. Sometimes for technical reasons, results cannot be generated. Additional samples may be needed if

results are not generated.

5. Testing of additional family members may be requested which could discover previously unknown information

about family relationships, such as non-paternity (someone who is not the biological father) or adoption.

6. Result disclosure: The company performing the test will disclose my test results ONLY to the doctor named on

the test order, or to his/her agent, unless otherwise authorized in writing by the patient, or required by law.

7. Genetic Counseling: I have been informed about the availability and importance of genetic counseling, if

applicable.

8. My signature below indicates that I have read, or had read to me, and understand the above information. The decision to consent to, or refuse, the above testing is entirely mine. I have had the opportunity to discuss it, including the purposes, limitations, and possible risks, with my doctor or someone my doctor has designated. I have all the information I want, and all my questions have been satisfactorily answered.

YES, I give consent for carrier testing.

______________________________________ Patient Signature

______________________________________ Patient Name (Print) Date

NO, I do not give consent for carrier testing.

______________________________________ Patient Signature

______________________________________ Patient Name (Print) Date

Update 9/18

Blood Test Required for IVF Patients

Female Patients:

HIV I and II Antibody CMV IGG Hepatitis B Surface Antigen Hepatitis C Antibody RPR (Syphilis screening) Blood Type and Rh Blood Antibody Screen CBC (Complete Blood Count) with Differential Rubella Titer Varicella IGG Prolactin TSH (Thyroid Stimulating Hormone) AMH (Anti Mullerian Hormone) Gonorrhea/Chlamydia Vitamin D-3 25-OH

** Genetic Screening

Male Patients:

HIV I and II Antibody Hepatitis B Surface Antigen Hepatitis C Antibody RPR (Syphilis screening) Blood Type and Rh Gonorrhea/Chlamydia

** Genetic Screening

for care and treatment rendered at the ambulatory surgical facility.

A patient has the right to be provided, upon request, information pertaining to the process of credentialing of the practioners rendering care and treatment at the ambulatory surgical facility.

A patient has the right not to be misled by the organization’s marketing or advertising

regarding their competence and capabilities.

A patient has the right to obtain the names, addresses, and telephone numbers from the Administrative Director, or designee, of the governmental offices where complaints may be lodged.

A patient has the right to be informed of a physician’s financial interest in and ownership of the facility in accordance with federal and state regulations.

A patient has the right to change their provider if other qualified providers are available.

A patient has the right, without recrimination, to voice comments, suggestions, complaints, and

grievances regarding care; to have those complaints reviewed and when possible, resolved; and when not resolved, to obtain information regarding external appeals, as required by state and Federal law and regulations.

The patient may contact the following individual who serves as the Grievance Officer at the facility to express a complaint or grievance:

Regina Plunkett, RN Grievance Officer Phone # 484-380-4900

You may contact the Department of Health complaint hotline 24 hours a day, 7 days a week at 1-800-254-5164 with any complaint or

grievance should it not be resolved by the Center to your satisfaction. Complaints can be mailed to the following:

Bureau Director PA Department of Health

Division of Acute and Ambulatory Care Health and Welfare Building

8th Floor West 625 Forster Street

Harrisburg, PA 17120

PATIENTS’ RESPONSIBILITIES

A patient is responsible for providing complete and accurate information to the best of his/her ability about his/her health, any medications, including over the counter products and dietary supplements as well as any allergies or sensitivities and for following their physician’s instructions and medical orders.

A patient is responsible for reporting whether he/she clearly comprehends a contemplated course of action and what is expected of them.

The ambulatory surgery facility expects that the patient will cooperate with all ambulatory surgery facility personnel and ask questions if directions and/or procedures are not clearly understood.

A patient is expected to be respectful of the property of other persons and the property of the ambulatory surgery facility.

A patient assumes financial responsibility of paying for all services rendered whether through third party payors (his/her insurance company) or being personally responsible for payment for any services which are not covered by his/her insurance policies.

A patient will inform his/her provider about any living will, medical power of attorney or other directive that could affect his/her care.

A patient will provide a responsible adult to transport him/her home from the facility and remain with him/her for 24 hours, if required by his/her provider.

The physicians and staff of Main Line Fertility Center are committed to serving their patients and families with the highest standards of care. We strive to continuously improve our standards through education, technology, and awareness of health care costs to meet the ever-changing needs of our patients.

825 Old Lancaster Road, Suite 170 Bryn Mawr, PA 19010

484-380-4900

PATIENTS’ RIGHTS

A patient has the right to respectful, considerate, private, and dignified care given by competent personnel.

A patient has a right to exercise his/her rights without being subjected to discrimination or reprisal.

A patient, if adjudged incompetent under applicable State laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under State law to act on the patient’s behalf. If the State

court has not adjudged a patient incompetent, any legal representative designated by the patient in accordance with State law may exercise the patient’s rights to the extent allowed by State law.

A patient has the right, upon request, to be given the name of his/her attending practioner, the names of all other practioners directly participating in his/her care, and the names and functions of other health care persons having direct contact with the patient.

A patient has the right to have records pertaining to his/her medical care treated as confidential, except as otherwise provided by law, or third-party contractual agreement.

A patient has the right to the opportunity to approve or refuse release of his/her medical records prior to submission to any party, including third parties based on contractual arrangements, except as otherwise provided by law.

A patient has the right to consideration of privacy concerning his own medical care program. Case discussion, consultation, examination, and treatment are considered confidential and shall be conducted discreetly.

A patient has the right to expect emergency procedures to be implemented without unnecessary delay.

A patient has the right to know what ambulatory surgery facility rules and regulations apply to

his/her conduct as a patient.

A patient has the right to be given the opportunity to participate in decisions involving his/her health care, except when such participation in contraindicated for medical reasons.

A patient has the right to quality care and high professional standards that are continually

maintained and reviewed in a safe setting free from all forms of abuse or harassment.

A patient has the right to full information in layman’s terms, concerning diagnosis, evaluation, treatment, and prognosis, including information about alternative treatments and possible complications. When it is not medically advisable to give the information to the patient, the information shall be given on his behalf to the responsible person.

Except for emergencies, the practioner shall obtain the necessary informed consent prior to the start of a procedure. Informed consent is defined in Section 103 of the Health Care

Services Malpractice Act (40 P.S. § 1301.103).

A patient, or, if the patient is unable to give informed consent, a person responsible for the patient, has the right to be advised when a practioner is considering the patient as part of a medical care research program or donor program, and the patient, or responsible person, shall give informed consent prior to actual participation in the program. A patient, or responsible person, may refuse to continue in a program to which he or she has previously given informed consent.

A patient has the right to information on advance directives, as required by state or

Federal law and regulations.

A patient has the right to refuse drugs or procedures, to the extent permitted by statue, and a practioner shall inform the patient of the medical consequences of the patient’s refusal of drugs or procedures.

A patient has the right to medical and nursing services without discrimination based upon age,

race, color, religion, gender, national origin, handicap, disability, or source of payment.

A patient who does not speak English shall have access, when possible, to an interpreter.

A patient who is blind or deaf shall have alternative communicative assistance available to them, if requested.

A patient, or patient designee, upon request,

shall have access to the information contained in his/her medical records at the ambulatory surgical facility, unless the attending practioner for medical reasons specifically restricts access.

A patient has the right to expect good management techniques to be practiced within the ambulatory surgical facility. These techniques shall make effective use of the patient’s time and shall avoid personal discomfort of the patient.

A patient has the right to be transferred to another facility, with notification to the patient’s responsible party, when an emergency occurs and requires transfer to a location capable of

providing emergency services. (The institution to which the patient is transferred shall be notified prior to the patient’s transfer.)

A patient has the right to examine and receive a detailed explanation of his/her bill.

A patient has the right to expect that the ambulatory surgical facility will provide information for continuing health requirements following discharge and the means for meeting them.

A patient has the right to be informed of his/her rights, responsibilities, and expected conduct by the ambulatory surgical facility prior to admission.

A patient has the right to information covering the services available at the ambulatory surgical facility, the fees related to those services, and the payment policies governing restitution for services rendered.

A patient has the right to information on the provision of after hours and emergency services

Directions to Main Line

Fertility Center:

We are conveniently located at:

825 Old Lancaster Road Suite 170

Bryn Mawr, PA 19010

Main Line Fertility is located four miles outside the western city limits of Philadelphia in Bryn Mawr, PA. Philadelphia is served by national train and bus transportation and by national and international air transportation. Once in Philadelphia, you can get to Bryn Mawr by car, taxi, train, or bus via the following directions:

Driving Directions:

From the North:

Take I-95 South. In Philadelphia, exit I-95 onto I-676-76 West to I-476 South (Blue Route) to Exit 13 (Villanova/St. David’s). At light, take Route 30 East (Lancaster Avenue) for 2.25 miles. Take a right at Bryn Mawr Avenue. Take the next right onto Old Lancaster Road. The Center is located in the building on the right (#825). Park in the Bryn Mawr Hospital Parking Garage on your left.

From the South:

Take I-95 North to I-476 South (Blue Route). Travel to Exit 13 (Villanova/St. David’s). At light, take Route 30 East (Lancaster Avenue) for 2.25 miles.

Take a right at Bryn Mawr Avenue. Take the next right onto Old Lancaster Road. The Center is located in the building on the right (#825). Park in the Bryn Mawr Hospital Parking Garage on your left.

From the East/West:

Take the Pennsylvania Turnpike to the Valley Forge Interchange (Exit 326). Take I-76 East to I-476 South (Blue Route). Exit I-476 South at Exit 13 (Villanova/St. David’s). At light, take Route 30 East (Lancaster Avenue) for 2.25 miles. Take a right at Bryn Mawr Avenue. Take the next right onto Old Lancaster Road. The Center is located in the building on the right (#825). Park in the Bryn Mawr Hospital Parking Garage on your left.

Public Transportation:

From Center City Philadelphia and west to Paoli:

By train, from Philadelphia’s 30th

Street or Suburban Station, take SEPTA’s R5 “Paoli Local” to Bryn Mawr. From the station it is a 15-minute walk across Lancaster Avenue, take the next right onto Old Lancaster Road, the Center is located in the building on the right (#825).

By subway and bus, take the Market Frankford Elevated Line to the 69th Street Terminal and transfer to the 105 bus to Bryn Mawr. The 105 bus travels along Lancaster Avenue from Paoli to Center City.


484-380-4900

Dear Patient:

Welcome to the Main Line Fertility Center. The mission of our experienced health care staff is to offer quality, state-of-the-art diagnostic testing and treatment in a relaxed, comfortable, and personalized setting.

We are committed to making your surgery as safe and effective as possible. In order to aid in our delivery of safe care, please provide important medical and health information to the staff at the facility. Finally, please questions any variation in medications, treatments, and plan of care from what you have been informed to expect.

Should you have any questions or concerns about your upcoming surgery, please call your physician’s office first. You can reach the staff at the Center at 484-380-4900 between the hours of 7:00 a.m. and 4:00 p.m., Monday through Friday.

• Do not eat or drink anything, including water, after midnight the day before the surgery unless otherwise directed by your physician.

• Your physician will review your medications and determine if any changes are needed for the day of surgery.

• On the day of surgery, notify your physician if you have had any changes in your health since the surgery was scheduled.

• Leave all jewelry and valuables at home.

• Remove all nail polish, make-up, and contact lenses before you come to the Center.

• Wear casual, loose clothing. During the surgery, you will wear a patient gown provided by the Center.

• Please bring all insurance cards with you.

• Arrange for transportation home after surgery. You will not be allowed to drive home from your surgery. Your driver should remain at the Center, as you will be discharged shortly after the completion of your surgery.

• You may not take the bus or a taxi home.

• When you arrive home wait at least 12 hours before you:

• resume normal activities

• drive or operate any equipment

• drink alcoholic beverages

• You will receive other instructions at the time of your discharge.

The physicians and staff of the Main Line Fertility Center are committed to serving their patients and families with the highest standards of care. We continuously strive to improve our standards through education, technology, and awareness of health care costs to meet the ever-changing needs of our patients.

Main Line may contact you to provide information

about treatment alternatives or other health-related

benefits and services that may be of interest to you.

To the extent that Main Line is designated an affiliated

covered entity, the covered entities that comprise

Main Line may share your health information with one

another as if they were a single covered entity.

Main Line is required to notify you of any breach of

unsecured health information about you. Main Line

will notify you of any breach in such manner and at

such time as required by 45 C.F.R. Part 164, Subpart D,

which governs what a covered entity like Main Line

must do in the event of an impermissible acquisition,

access, use, or disclosure which compromises the

privacy or security of a patient’s health information.

We may change our policies at any time and make the

new policies effective for all information we maintain.

Before we make any significant change in our policies,

we will change this Notice. If we change this Notice,

we will post the new notice in waiting areas, make it

available on our external website (www.mainlinefertility.com), and copies will be available

by contacting the Main Line representative listed below.

You can request a copy of our Notice at any time. For

more information about our privacy practices, contact the

Main Line representative listed below.

Individual Rights

You have the right to request that Main Line restrict the manner in which we communicate health information to

you. Your request must be in writing, and Main Line will

accommodate any reasonable request to provide health

information by alternative means or at alternative locations. Please forward your written request to the

Main Line representative listed below.

With few limitations, you have the right to look at and/or

get a copy of your health information. This request must

be in writing. If you request copies, we may charge a per

page fee to cover costs. If we deny you access to requested information, you may appeal the denial in

certain circumstances. If you believe that information in

your record is incorrect or incomplete, you have the right

to request that we correct, or add to, the existing information. This request must be in writing and be

supported by a reason. We have the right to deny the

request. Please forward your written request to access or

amend information to the Main Line representative listed

below.

You have the right to receive a list of instances where we

have disclosed health information about you for reasons

other than treatment, payment or operational purposes (as well as other limited exceptions) during the six (6)

years prior to the date on which your request for an

accounting is made. This request must also be made in

writing. Main Line may not account for disclosures made before the Standards’ effective date. We reserve the right

to charge for multiple requests for disclosure to cover

costs incurred.

You have the right to request in writing that we not use or

disclose your information for treatment, payment or operational purposes, or to family, friends and individuals

involved in your care. We will consider your request but

are not legally required to accept it. If you have paid for

services out-of-pocket, in full, you also have the right to request that we not disclose health information relating

solely to those services to your health plan, except when

we are required by law to do so.

You have the right to obtain a paper copy of this notice, if

you received it electronically. Please submit your request

in writing to the Main Line representative listed below.

Complaints

If you are concerned that we have violated your privacy

rights, or you disagree with a decision we made about access to your records, you may contact the person listed

below. You may also send a written complaint to the U.S.

Department of Health and Human Services. The person

listed below can provide you with the appropriate address upon request. You will not be penalized for filing a

complaint in good faith.

Our Legal Duty

We are required by law to protect the privacy of your information, provide this Notice about our information

practices, and follow the information practices of this

Notice currently in effect.

If you have any questions or complaints, please contact:

Lisa Pearson

Supervisor/Privacy Officer

915 Old Fern Hill Road

Building B, Suite 101

West Chester, PA 19380

610-840-0061

Notice of Privacy Practices for


484-380-4900

THIS NOTICE DESCIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW TO GET ACCESS

TO THIS INFORMATION. PLEASE READ IT CAREFULLY.

If you have any questions regarding this notice, you may contact our privacy officer at the facility address.

Effective Date: 9/23/2013

This notice covers the privacy practices of Main Line

Fertility Center, Inc. and Main Line Fertility and

Reproductive Medicine, LTD (collectively referred to

herein as “Main Line”), which is a covered entity as

that term is defined in the Standards for Privacy of

Individually Identifiable Health Information at 45 C.F.R.

Parts 160 and 164. In accordance with these

Standards, Main Line must take steps to protect the

privacy of your health information. Health information

includes information that we have created or received

regarding your health or payment for health care

services. It includes both your medical records and

personal information such as your name, social security

number, address and telephone number.

Uses and Disclosures of Health Information

We may use and disclose health information about you for treatment, payment and operational purposes.

Treatment means the provision, coordination, or

management of health care and related services,

including consultations and referrals among health

care providers. Therefore, Main Line may provide

health information to your doctor(s), or to a facility

where you are receiving medical care. Payment

generally means obtaining reimbursement for the

provision of health care services. Payment also

includes, but is not limited to, determinations of

eligibility for insurance coverage; risk adjustment;

billing; claims management; collection activities; and

utilization review activities. For example, Main Line

may disclose health information to your health plan in

order to determine whether medical services are

covered. Operational purposes means activities that

are necessary for Main Line’s operations. These

activities include, but are not limited to, quality

assessment; credentialing; underwriting; legal services;

and business planning and development, as well as

general administrative activities. For example, Main

Line may use and disclose your health information to

measure the quality of the services you receive.

Information received by Main Line or our business

associates from certain mental health providers or

from federally funded drug or alcohol treatment

programs may be subject to limits on redisclosure set

forth in applicable state or federal law or regulations.

Main Line may use or disclose information about you

without your authorization or permission for several

other reasons. These reasons include:

• To a family member, other relative, or a

close personal friend or for disaster relief.

Main Line may disclose to a family member,

other relative, or a close personal friend, or

any other person you identify, such health

information directly relevant to the person’s

involvement with your care or payment of

care. Main Line will attempt to obtain your

agreement to such use or disclosure, if

possible. If agreement is not possible due to

your incapacity or an emergency

circumstance, we will exercise our

professional judgment in disclosing health

information that is directly relevant to the

person’s involvement with your health care.

• As required by law. A federal, state or local

law may require Main Line to use or disclose

your health information for certain

purposes.

• For public health activities. Main Line may

disclose your health information to a public

health authority or for public health

activities, such as notifying a person about

exposure to a communicable disease, or

participating in a public health investigation.

• To report abuse, neglect or domestic

violence. Main Line may disclose your

health information when we reasonably

believe you are a victim of abuse, neglect, or

domestic violence to a government

authority, including a social service or

protective services agency.

• For health oversight activities. Main Line

may disclose your health information to a

government agency that oversees the health

care system.

• For judicial and administrative proceedings.

Main Line may disclose your health

information pursuant to a court order,

subpoena, discovery request or other legal

process.

• To law enforcement. Main Line may

disclose your health information to law

enforcement under limited circumstances,

such as to comply with a court order, search

warrant, or administrative request.

• To coroners and medical examiners. Main

Line may disclose your health information to

a coroner or medical examiner for the

purposes of identification, determining a

cause of death, or other duties as authorized

by law.

• For organ, eye or tissue donation. Main

Line may disclose your health information to

an organ procurement organization or other

entities engaged in procurement in order to

facilitate procurement.

• For research purposes. Main Line may

disclose your health information to a

researcher provided the researcher has met

certain conditions.

• To avert a serious threat to health or safety.

Main Line may use or disclose your health

information if, in good faith, we believe that

such information is necessary to avert a

serious and imminent threat to the health or

safety of a person or the public or to identify

or apprehend a suspect.

• For specialized government functions. Your

health information may be disclosed for

military, national security, intelligence, or

correctional or custodial activities.

• For worker’s compensation. Main Line may

disclose health information regarding work-

related injuries in compliance with worker’s

compensation laws.

In any other situation, we will ask for your written

authorization before using or disclosing any identifiable

health information about you. For example, if you are

applying for a life insurance policy, Main Line must

obtain your written authorization prior to disclosing

your health information to the insurance company. The following uses and disclosures also will be made

only with your written authorization: (i) uses and

disclosures for marketing purposes; (ii) uses and

disclosures that constitute the sale of health

information; (iii) most uses and disclosures of

psychotherapy notes (in the event Main Line has any

psychotherapy notes); and (iv) other uses and

disclosures not described in this Notice. Main Line has

prepared authorization forms for your use, and will

make them available to you upon request. If you

choose to sign an authorization to disclose information,

you can later revoke that authorization to stop any

future uses and disclosures.

The next sections contain IVF consents.

Effective January 1st, 2019, the IVF consents must be completed, notarized* and returned to

the IVF staff prior to an IVF cycle start.

*If it is impossible to have the consents notarized they must be signed by both parties in the presence of a Main Line Fertility employee after presenting photo ID prior to an IVF cycle start.

of 21 Informed Consent for Assisted Reproductive Technology (ART) version 2018 Main Line Fertility Center

www.mainlinefertility.com

Assisted Reproductive Technology (ART) Process, Risk, and Consent

In Vitro Fertilization (IVF) is a treatment for that removes eggs from a woman’s ovary or ovaries to achieve a pregnancy either at that time or at a later time. A patient can use sperm provided by her partner or from a donor for the insemination of her eggs, and have the resulting embryos transferred to her uterus or use a gestational carrier.

In Vitro Fertilization Process & Risks

 

An IVF cycle typically includes the following steps or procedures:

Taking medicine to grow several follicles (fluid filled sac that may contain an egg) at once

Removing the eggs from the ovary or ovaries

Mixing eggs and sperm together to attempt fertilization

Growing any resulting fertilized eggs (embryos) in the lab

Placement ("transfer") of one or more embryo(s) into the uterus

Taking hormone medications to help you have a successful pregnancy

Sometimes, other IVF steps may be included:

Injecting individual sperm into each egg, called Intracytoplasmic Sperm Injection (ICSI)

Cryopreservation (freezing) of eggs or embryos that are not transferred to the uterus

Genetic testing of the embryos for abnormal genes or number of chromosomes (PGT=Preimplantation Genetic Testing).

Date: ________________________ Patient Last Name: ______________________________ First Name: _____________________

ID#_______________________________________ Gender – M / F (Circle One)

Partner Last Name: ______________________________ First Name: _____________________

ID #_______________________________________ Gender – M / F (Circle One)



Medications for IVF Treatment

The success of IVF largely depends on growing several follicles at once.

Injections of the natural hormones FSH and/or LH (gonadotropins) are used for this purpose.

Other medications are used to keep ovulation from occurring too soon.

Sometimes the ovaries respond too strongly—and sometimes not strongly enough.

Some medicines commonly used in an IVF cycle:

Gonadotropins, or injectable “fertility drugs” (Follistim®, Gonal-F®, Menopur®, low dose hCG or human chorionic gonadotropin): These are all-natural hormones that help the ovary to grow several follicles at once over an average of 10 days. These injections may be given either just under the skin or directly into muscle.

Risks/side effects of administering any medication by injection can include bruising, redness, swelling, or pain at the injection site. In rare cases, there may be an allergic reaction. Some women have bloating or minor discomfort as the ovaries briefly become enlarged. About 1% of women will develop Ovarian Hyperstimulation Syndrome (OHSS) [see “Risks to the Woman” section]. Other side effects may include headaches, weight gain, feeling tired, mood swings, nausea, or clots in blood vessels. If testing prior to the IVF cycle has shown that the woman is thought to have a lower number of eggs available, the medications may not help multiple follicles to grow. There may be very few or no eggs harvested at the egg retrieval procedure, or the cycle may be canceled before egg retrieval can be attempted.

GnRH-agonists (leuprolide acetate) (Lupron®): This injectable medication comes in two forms: One is a short-acting form that needs to be injected daily, and the other is a long-acting form that lasts for 1-3 months. Leuprolide is often given to help prevent the release of eggs (by ovulation) before they can be retrieved. Leuprolide can also be used to start the growth of follicles containing eggs, or trigger the final stages of their growth. Leuprolide is approved by the FDA (U.S. Food and Drug Administration), but not approved for use in IVF. Because it has been studied in IVF patients, the medicine has been used in IVF for more than 20 years.

Leuprolide may cause several side effects including a skin reaction at the injection site, hot flashes, vaginal dryness, nausea, headaches, and muscle aches. Some women may retain fluid or feel depressed, and long-term use can result in bone loss. No long term or serious side effects are known. If Leuprolide is given in a cycle after ovulation has occurred, condoms should be used for birth control during that month. Leuprolide has not been linked with any birth defects, but it should be stopped if you become pregnant while taking it.

GnRH-antagonists (ganirelix acetate or cetrorelix acetate) (Ganirelix®, Cetrotide®): These drugs are used to prevent premature ovulation. Side effects may include stomach pain, headaches, skin reactions at the injection site, and nausea.

Human chorionic gonadotropin (hCG) (Profasi®, Novarel®, Pregnyl®, Ovidrel®): hCG is a natural hormone used in IVF to help the eggs become mature, ready to harvest, and be fertilized. This drug must be taken at an exact time prior to retrieving the eggs. Side effects can include breast tenderness, bloating, and pelvic pain.

Progesterone, and in some cases, estradiol: These two hormones are normally produced by the ovaries after ovulation, however, after egg retrieval, the ovaries will not produce enough of these hormones to support a pregnancy. Adding them helps improve the chances of getting pregnant and maintaining the pregnancy. Progesterone can be taken as a daily intramuscular injection (injection into muscle), or by placing a suppository or gel (Endometrin®, Crinone®, Prochieve®, Prometrium®, or pharmacist-compounded suppositories) directly into the vagina as frequently as three times per day after egg retrieval. Progesterone is often continued for some weeks after you become pregnant. Progesterone has not been shown to cause birth defects. Side effects of progesterone can include depression, sleepiness, an allergic reaction, infection or pain at the injection site. Estradiol can be taken orally, in a patch, as an intramuscular shot, or as a vaginal



suppository. Side effects of estradiol include nausea, irritation at the site of the injection or patch, and the risk of blood clots or stroke.

Oral contraceptive pills (birth control pills): Occasionally your physician may ask you to take birth control pills for 2 to 4 weeks before starting hormone stimulation injections. This is to slow down hormone production or to schedule a treatment cycle. Side effects include bleeding, headache, breast tenderness, nausea, and swelling. There is also a risk of blood clots or, very rarely, stroke.

Growth Hormone: This medicine is used in some regimens in hopes of improving embryo quality. It is given as

a daily injection, and may cause some local irritation.

Testosterone or DHEA: This medicine is used in some treatments in hopes of increasing the number of eggs retrieved. It is often given as a pill, patch, or cream, for one to three months before ovarian stimulation begins.

Clomid or Letrozole: These oral medicines are used in some treatments to increase the number of growing eggs or reduce the estrogen level in the bloodstream. Short-term side effects in some women include headache, hot flashes, or increased moodiness.

Coenzyme Q10: This supplemental medicine is often recommended to improve egg quality, and is taken by mouth for one to three months before ovarian stimulation begins.

Other medications: Antibiotics may be given for a short time during the treatment cycle to reduce the risk of infection from egg retrieval or embryo transfer. Antibiotic use may cause several side effects, including vaginal yeast infection, nausea, vomiting, diarrhea, rashes, sensitivity to the sun, or allergic reactions.

Your doctor may suggest using anti-anxiety medications or a muscle relaxant before the embryo transfer. The most common side effect of these medicines is drowsiness.

Other medicines such as steroids, heparin, low molecular weight heparin, or aspirin may also be recommended.

I/We have read and understand the foregoing Medications for IVF Treatment

__________________________ ___________________________ _________________ Signature of Patient Print Name Date __________________________ ___________________________ _________________ Signature of Partner Print Name Date



Transvaginal Oocyte (Egg) Retrieval

Eggs are removed from the ovary with a needle under ultrasound guidance.

Anesthesia is given to make this more comfortable.

Complications such as injury and infection are rare.

Oocyte retrieval is the removal of eggs from the ovary. Anesthesia is generally used to reduce or eliminate pain. Before removing the eggs, the doctor will look at your ovaries using an ultrasound probe placed into the vagina. A long needle, which can be seen on ultrasound, is attached to the ultrasound probe, guiding the needle into the ovaries so that the physician can draw out fluid, eggs, and egg-supporting cells from the follicles. On rare occasions, the ovaries cannot be reached through the vagina, in which case, the eggs might be removed by guiding the needle through the abdomen. Risks of egg retrieval: Infection: Antibiotics may be used before the egg retrieval to help reduce the chance of infection. Bacteria from the vagina may be transferred into the pelvis or ovaries by the needle causing an infection of nearby organs. The incidence of infection after egg retrieval is very small (less than 0.1%). If you do get an infection, you may be given antibiotics. Severe infections sometimes require surgery to remove infected tissue. Infections can reduce your chance of getting pregnant in the future. Bleeding: The needle passes through the vaginal wall and into the ovary to obtain the eggs. Both structures contain blood vessels; therefore, small amounts of blood may be lost while removing the eggs. The risk of major bleeding is small (< 0.1%). Major bleeding may require a blood transfusion, surgery to stop, and could result in the removal of an ovary. If bleeding occurs and is not noticed (also rare), it can lead to death. Trauma: The risk of damage during egg retrieval is very low. Even with ultrasound guidance, nearby organs can be damaged, including damage to the intestines, appendix, bladder, ureters, and ovary. In some cases, a damaged organ may need to be fixed or removed through surgery. Anesthesia: The use of anesthesia while removing eggs can cause an allergic reaction, low blood pressure, nausea or vomiting and in rare cases, death. Failure: Sometimes no eggs are found during the retrieval process. In other cases, the eggs are not normal, or are of poor quality, preventing you from having a successful pregnancy.

I/We have read and understand the foregoing Transvaginal Oocyte (Egg) Retrieval




In vitro fertilization and embryo culture

Sperm and eggs are placed together in culture media.

The dish is incubated under special conditions to promote fertilization.

The fluid in the dish (culture medium) helps the sperm fertilize the egg and aids in embryo grow. Each clinic may have its own media for growing embryos.

In most cases, the embryologist chooses the best embryos for embryo transfer by the way they look under a microscope.

After eggs are retrieved, they are moved to the embryology laboratory where they are kept in conditions that support their growth. The eggs are placed in small dishes or tubes containing "culture medium”, fluid made to resemble the conditions in the Fallopian tubes and uterus, to support development of the embryos. The eggs are then placed into incubators, which keep the temperature, humidity, gas, and light at controlled levels. Three to four hours after the eggs are retrieved, sperm are placed in the culture medium with the eggs. In some cases, individual sperm are injected into each mature egg in a technique called Intracytoplasmic Sperm Injection (ICSI) (see “ICSI” section). The eggs are then returned to the incubator, where they remain to develop and grow. They are inspected for progress at intervals over the next few days. Embryo development usually proceeds along the following schedule:

Day 1: The lab checks for signs of fertilization. At this stage, the normally fertilized egg is still a single cell with 2 nuclei, called a 2PN or zygote.

Day 2: Normally developing embryos will divide into 2 to 4 cells.

Day 3: Normally developing embryos will continue to divide and contain 4 to 8 cells.

Day 4: The cells of the embryo begin to merge to form a solid ball of cells called a morula (named because it looks like a mulberry).

Day 5: Normally developing embryos now have 100 cells or more and are called blastocysts. They have a fluid-filled cavity (blastocoel) a small cluster of cells on the inside (inner cell mass), and an outer layer of cells that develop into the placenta (the trophectoderm).

It is important to understand that many eggs and embryos are abnormal, meaning that some eggs will not fertilize, some embryos will not divide at a normal rate and some embryos may stop growing. Even if your embryo(s) develop normally in the lab, you still may not get pregnant. Some embryos end up being genetically abnormal, after being tested for genetic abnormalities (“preimplantation genetic testing, or “PGT”), an additional lab procedure. The best embryo(s) for transfer are usually selected by the way they look under the microscope. Although we take great care of all eggs, embryos, and sperm in the lab, there are many reasons why pregnancy may not occur with IVF:

The eggs may fail to fertilize.

One or more eggs may fertilize abnormally, leading to an abnormal number of chromosomes in the embryo. These abnormal embryos will not be transferred and will be destroyed.

The fertilized eggs may fall apart (fragment) before dividing into embryos, or the embryos may not develop normally.

On rare occasions the eggs or embryos may be harmed by contact with bacteria in the lab.

In spite of backup systems in place, lab equipment may fail or power may be lost. Both can lead to the destruction of eggs, sperm, and embryos.

A lab accident or human error can happen and may lead to embryo loss.

Other unplanned events may prevent any step of the process from being performed or prevent a pregnancy from occurring.

Hurricanes, floods, or other “acts of God,” including bombings or other terrorist acts, could destroy the laboratory or its contents, including any sperm, eggs, or embryos.



Quality control is the process of running tests to ensure that lab conditions are optimal for embryos growth. Systems in the lab are frequently checked to make sure conditions are optimal. Sometimes immature or abnormal eggs, or embryos that have not developed normally, can be used for quality control checks before they are discarded. None of the material that would normally be discarded--blood, tissues eggs, sperm or abnormal embryos--will be used to create a pregnancy or a cell line.

I/We have read and understand the foregoing In vitro fertilization and embryo culture


Embryo transfer

After a few days of development, the best-developed embryos are chosen for transfer.

The number of embryos transferred affects the pregnancy rate and the risk of twins or other multiple pregnancies.

The woman’s age and the quality of the developing embryo(s) have the greatest effect on pregnancy outcome.

Embryos are placed in the uterus using a thin tube.

Extra, normally developing embryos that are not transferred can be frozen for future use.

After a few days of development, the embryo transfer takes place, or the embryos are frozen for future use. One or more embryos are placed in the thin tube called a catheter, placed through the cervix into the uterus under ultrasound guidance to assist in guiding the catheter. Although this is a simple process, there are some very rare risks, including infection, loss of the embryo(s), or damage to the embryo(s). Not all embryos become pregnancies, and not all pregnancies are normal or grow in the correct place – tubal pregnancies can occur.

The number of embryos to transfer is an important decision. A woman’s age and the quality of the embryo affect both the chance for pregnancy as well as the chance for multiple embryos to implant. If multiple embryos implant, a multiple pregnancy (twins, triplets, or more) will result. In some cases, an embryo can split into two (identical twins) after transfer. Before the transfer, it is critical to discuss with your doctor how many embryos to transfer.



Guidelines for the maximum number of embryos to transfer are given below.

RECOMMENDED LIMITS ON THE NUMBER OF EMBRYOS TO TRANSFER

Age: <35 35-37 38-40 41-42 > 42

Cleavage-stage embryos

Normal # chromosomes 1 1 1 1 1

From Egg Donor <35 1 1 1 1 1

Other favorable* 1 1 ≤3 ≤4 Not known

All others ≤2 ≤3 ≤4 ≤5 Not known

Blastocyst-stage embryos

Normal # chromosomes 1 1 1 1 1

From Egg Donor <35 1 1 1 1 1

Other favorable* 1 1 ≤2 ≤3 Not known

All others ≤2 ≤2 ≤3 ≤3 Not known

*Other favorable = any ONE of these criteria: Fresh cycle: expectation of 1 or more high-quality embryos available for cryopreservation or previous live birth after an IVF cycle; Frozen Embryo Transfer (FET) cycle: availability of vitrified day-5 or day-6 blastocysts, Euploid (correct number of chromosomes) embryos, 1st FET cycle, or previous live birth after an IVF cycle. NOTE: IN THE EVENT OF A DIVORCE OR DISSOLUTION OF RELATIONSHIP, MLFC REQUIRES A VALID, FINAL, NON-APPEALABLE ORDER/DECREE BY A COURT OF COMPETENT JURISDICTION AND/OR A VALID SETTLEMENT AGREEMENT (AS DETERMINED IN MLFC’S SOLE DISCRETION), SPECIFICALLY ADDRESSING THE DISPOSITION OF EMBRYOS STORED WITH MLFC. PRIOR TO ANY EMBRYO TRANSFER A DISPOSITION OF EMBRYOS AGREEMENT MUST BE SIGNED BY ALL PARTIES.

I/We have read and understand the foregoing Embryo Transfer and Recommended Limits on Numbers of Embryos to Transfer


Hormonal support of the uterine lining

For pregnancy to occur, the embryo(s) must attach to the lining of the uterus, a process called implantation.

Implantation has a better chance of occurring if extra progesterone hormone is taken.

The most important hormones to support implantation are progesterone and estrogen. Normally, the ovaries make these hormones to support pregnancy, however, in IVF cycles, retrieving the eggs causes reduced production of progesterone and estrogen by the ovaries. Therefore, in most cases, progesterone and sometimes estrogen are routinely taken for several weeks to help support the pregnancy. Progesterone is most commonly taken as an injection or as a vaginal suppository. Estrogen can be taken as pills, an injection, vaginal suppositories, or a skin patch.



I/We have read and understand the foregoing Hormonal Support of the Uterine Lining


Additional Elements

Intracytoplasmic Sperm Injection (ICSI)

In some cases, fertilization may not happen when eggs and sperm are placed together in a lab dish. Injecting a sperm into each egg (ICSI, or intracytoplasmic sperm injection) may help fertilization occur.

ICSI does not guarantee normal fertilization.

There may be an increased risk of genetic problems in children born from ICSI.

ICSI will not improve any defects in the eggs.

ICSI involves the injection of a single sperm into the interior of an egg using an extremely thin glass needle. The sperm must be healthy, and the egg must be mature.

ICSI is utilized when the sperm count, movement (motility), and/or morphology is poor. Live birth rates are very similar to those after IVF for men with normal sperm counts.

ICSI may be associated with a slightly higher risk of birth defects. It is hard to know if the increased risk is due to the ICSI procedure itself or to defects in the sperm. The risk of birth defects after ICSI is still quite low (4.2% compared with 3% in children conceived naturally). Experts are still debating the impact of ICSI on the mental and physical development of children. Most recent studies have not detected differences in the development of children born after ICSI, regular IVF, or natural conception.

Children conceived by ICSI have slightly increased problems with their sex chromosomes (the X and Y chromosomes) compared to children conceived by IVF alone, but only by a very small margin (0.8% to 1.0% for ICSI pregnancies compared to 0.2% for IVF pregnancies). The reason for the difference is not clear, but may be caused by the ICSI procedure itself, or by the sperm. Men with sperm problems such as very low count and low motility are more likely to have genetic abnormalities, and often produce sperm with abnormal chromosomes, especially with abnormal sex chromosomes (X and Y). If sperm with abnormal chromosomes produces pregnancies, the pregnancies will likely carry the same defects. Translocations (a re-arrangement of chromosomes that can cause miscarriage or birth defects) may be more common after ICSI.

Some men with extremely low sperm counts or no sperm have small deletions on their Y chromosomes. In some of these cases, sperm can be obtained from the testicles via a surgical procedure to fertilize eggs with ICSI. Any sperm containing a Y chromosome microdeletion will pass on the deletion to any male child. These male children will also carry the microdeletion and may be infertile. A Y chromosome microdeletion can often, but not always, be detected by a blood test. This is because the chromosomes in the sperm may not always be the same as those seen when tested in the blood.



Some men are infertile because the tubes connecting the testes to the penis did not form correctly (congenital bilateral absence of the vas deferens [CBAVD]). These men can still father children, but sperm must be taken directly from the testicles or the tubes (epididymis) next to them, and ICSI must be used. These men have a mild form of cystic fibrosis (CF), which can be passed on to their children. Men with CBAVD and their partners should be tested for CF gene mutations before treatment. However, some CF mutations may not be detected by current tests, so that some parents who test negative for CF mutations can still have children affected by CF.

I/We have read and understand the foregoing Intracytoplasmic Sperm Injection (ICSI), and I/we consent to ICSI, if indicated


Preimplantation Genetic Testing (PGT)

Preimplantation genetic testing of embryos requires removal of cells from the embryo (embryo biopsy).

This test is most often done on Day 5 or Day 6 of embryo development, but it may be done sooner or later in some circumstances.

The cells removed from the embryo may be sent to an off-site lab for the testing, while embryos remain at the clinic.

In most cases, the tested embryos will need to be frozen (cryopreserved) while the test is being run.

Test results may not be 100% correct.

There are several reasons that some patients choose to do PGT. Current reasons include:

determining whether the embryo has the incorrect number of chromosomes (“PGT-A”).

determining whether the embryo has a structural rearrangement of its chromosomal material (“PGT-SR”).

determining whether the embryo has a specific disease-causing mutation (“PGT-M”)

determining the gender of the embryo.

PGT does not guarantee that a pregnancy will occur, even if embryo tested is normal. Factors other than the genes influence pregnancy rates. Screening the embryo’s chromosomes (PGT-A), or testing for one specific genetic disease (PGT-M), does not guarantee that the embryo will be healthy and free of other disorders. For example, some common disorders that cannot be checked with PGT are autism and diabetes. Some birth defects may also occur even if chromosome screening is normal. An example of this would be a cleft lip or palate (failure of the lip and upper mouth to join properly). It is always a possibility that PGT will show that there are NO chromosomally normal embryos available to transfer.

Risks of embryo biopsy Damage. There is a small risk of damage to the embryo.

No result. The test may not give a result. It may be possible to repeat the biopsy and try again to test the

embryo.

Misdiagnosis. The test may give an incorrect result, indicating that a normal embryo is actually abnormal, or

that an abnormal embryo is actually normal, however, most testing is very accurate. Not all embryos are made

up of cells with identical genetics. Some embryos can be “mosaic”, which is when patches of cells within the



same embryo have different genetic makeup. Therefore, it is possible that test results of the biopsied cells do

not reflect the genetics of the entire embryo. Consequently, the current recommendation is to confirm the

result in early pregnancy.

Separate consents and agreements must be signed by patient and partner (if applicable) for PGT:

Main Line Fertility and Reproductive Medicine Embryo Biopsy for Preimplantation Genetic Testing (PGT)

Consent Form

Genetics Lab Consent for PGT

I/We have read and understand the foregoing Preimplantation Genetic Testing (PGT)


Assisted Hatching

Assisted hatching involves making a hole in the outer shell (zona pellucida) that surrounds the embryo.

Hatching may make it easier for embryos to be released from the shell and implant in the uterus.

The cells that make up the early embryo are coated with a membrane (shell) called the zona pellucida. Normally, as the embryo grows, this shell thins. This allows the embryo to be released or “hatch” from the shell. Only after hatching can the embryo implant in the uterus for the pregnancy to continue. Assisted hatching makes it easier for the embryo to escape the shell. This is done in the lab, by making a small hole in the shell with a laser. The procedure is usually done on the day of transfer, before placing the embryos into the transfer catheter.

Some programs use assisted hatching because of the belief that it improves implantation and birth rates, however there is no absolute evidence of this. In most cases, assisted hatching is believed to be helpful in women who are over 38 years old when their eggs are harvested, if they have failed to get pregnant in a previous IVF cycle, and/or when the shell around the embryo is extra thick. The thickness of the shell is checked on all embryos before embryo transfer. Assisted hatching does have some risks. Very rarely, the embryo can be damaged, lose cells, or even be destroyed. There is also a higher chance of having identical twins (a riskier pregnancy) if the embryos are cleavage stage (Day 3). There may also be other risks not yet known.

I/We have read and understand the foregoing Assisted Hatching, and I/we consent to Assisted Hatching, if indicated.




Cryopreservation (freezing)

Freezing of eggs and embryos provides additional chances for pregnancy in the future.

Frozen eggs and embryos do not always survive the process of freezing and thawing.

Freezing of eggs before fertilization does not work as well as freezing of embryos.

Ethical and legal questions can arise when couples separate or divorce. It is vital to agree on what will be done with remaining eggs or embryos in those cases, as well as in the case of death.

A person or couple with frozen eggs or embryos MUST be in touch with the clinic once a year.

There are yearly fees for keeping embryos or eggs frozen.

Sometimes there are normally developing embryos left after embryo transfer which can be frozen for future use. In some cases, the original plan may be to freeze all embryos from an IVF cycle (for example, for PGT). On the other hand, some women may wish to freeze their eggs because they are not ready to conceive now, or because they are planning to have therapy such as cancer treatment that could damage their eggs. Benefits of freezing:

Saves you from going through ovarian stimulation again if you need eggs or embryos in the future.

Allows you to transfer fewer embryos in the fresh cycle, saving the others for a frozen cycle, thus reducing the risk of a multiple pregnancy (twins, triplets, or greater).

Allows you to freeze all embryos in the fresh cycle to prevent over-stimulation of the ovaries.

Allows you to freeze embryos while waiting for test results from PGT.

Protects you if your future fertility is at risk because of surgery or other treatments such as cancer therapy.

There are different ways to freeze embryos. The most common are “slow” freezing and “rapid” freezing (called vitrification). You should know that embryos do not always survive the freezing and thawing process. There is always a risk that no embryos will survive. If this happens, the transfer will be cancelled. Transferring a thawed embryo into the uterus does not guarantee a pregnancy. Studies of animals and humans indicate that children born from frozen embryo cycles do not have any greater chance of birth defects than children born after fresh embryo transfers. However, until very large numbers of children have been born from frozen embryos, it is not possible to be absolutely certain that there are no increased risks. Foreseen and unforeseen circumstances (e.g. natural disasters, storage tank malfunctions, equipment failure, and power loss) may cause the eggs or embryo(s) to thaw, be damaged, and/or not survive. If you choose to freeze eggs or embryos, you MUST complete, and notarize the Disposition of Eggs or Disposition of Embryos agreement before freezing. The statement explains the choices you have for the disposition of the eggs or embryos in a variety of situations. You can submit a new statement later if you change your mind about your choices. For frozen embryos, any change requires that both parties — you and your partner-- agree in writing to the change. Be sure to let us now if you change your address. You must also pay storage fees as they come due.

I/We have read and understand the foregoing Cryopreservation (freezing)




Risks to the Woman

Medical Clearances If you are under the care of a physician for a medical or psychological condition, you will need to obtain a letter of medical clearance from your treating physician. Our goal is to ensure that you are medically and/or psychologically stable to undergo IVF procedures, including egg retrieval, embryo transfer and epididymal aspiration/testicular biopsy, and that the medications you are prescribed are safe during pregnancy. The clearance letter must contain the following information:

The condition for which you are being treated

A statement that you are stable to undergo IVF procedures under anesthesia

A statement that you are stable to attempt pregnancy.

Ovarian Hyperstimulation Syndrome (OHSS) OHSS is a side effect of stimulating the ovaries. Signs of mild OHSS include lower abdominal discomfort and distention, mild nausea/vomiting, diarrhea, shortness of breath on exertion. Moderate OHSS may cause increasing abdominal bloating and discomfort, ovarian enlargement, and rapid weight gain. With severe OHSS you may note decreased urination, shortness of breath, large distended abdomen, abdominal pain, and excessive weight gain. Changes in the level of red blood cells and electrolytes may cause kidney and liver problems, and in the most severe cases, blood clots, kidney failure, or death. These complications occur very rarely (in only 0.2% of all treatment cycles).

OHSS occurs at two stages:

early, 1 to 5 days after egg retrieval (as a result of the hCG trigger injection); and

late, 10 to 15 days after retrieval (because of the natural rise of hCG if pregnancy occurs).

The risk of severe problems from OHSS is much higher if you become pregnant. For this reason, your doctor may suggest that all of your embryos be frozen for later use instead of transferring them in the fresh cycle. A frozen transfer can be done later, when there is reduced risk of OHSS.

Cancer There is some concern that using fertility drugs can cause breast, ovarian, or uterine cancer. These cancers are more common in women with infertility, so it is difficult to know whether the reason for the cancer is infertility or use of the drugs. In current studies that take into consideration the increased risk of cancer due to infertility, there does not seem to be an increased risk of cancer due to the fertility drugs alone. More studies need be done to confirm whether there is an association of cancer with use of fertility drugs.

Risks of Pregnancy

Getting pregnant through IVF comes with certain risks. There may be other risks linked to IVF that are not known at this time. Please see the table below for certain known risks.



Risks of Pregnancy with IVF

Singleton Pregnancies Twin Pregnancies

Incidence in IVF Pregnancies (%)

Risk compared to other

infertile women

Risk compared to fertile women

Incidence in IVF Pregnancies (%)

Risk compared to other

infertile women

Risk compared to fertile women

Gestational diabetes

8.2% No difference

41% higher 10.7% No difference 23% higher

Pregnancy-induced

hypertension

12.6% No difference

No difference 25.5% No difference 15% higher

Placental complications

5.2% 95% higher


Primary cesarean delivery

32.2% 10% higher

20% higher 65.4% 8% higher 17% higher

Low birthweight (<5.5 pounds)

7.7% 21% higher

65% higher 50.4% No difference No difference

Preterm birth (<37 weeks gestation

10.3% 26% higher


In 2015 approximately 25% of IVF pregnancies were multiple pregnancies (twins, triplets, or greater), of which less than 1% are triplets or more. Identical twins occur in less than 5% of all IVF pregnancies and may happen more often after blastocyst (Day 5 or 6) transfers. Multiple pregnancies in general have an increased risk of pregnancy problems, including but not limited to: early delivery, pre-eclampsia (high blood pressure and protein in the urine), excess bleeding with delivery, and diabetes of pregnancy (gestational diabetes, and problems with the placenta (afterbirth). Other issues common with multiple pregnancy include gall bladder problems, skin problems, and the need for extra weight gain.

In IVF, embryos are transferred directly into the uterus. Still, tubal, cervical, or abdominal pregnancies may occur. These abnormal pregnancies may need to be treated with medication or surgery. Abnormal pregnancies within the uterus can also occur.

I/We have read and understand the foregoing Risks to the Woman




Risks to Your Baby

IVF babies may be at a slightly higher risk for birth defects and genetic defects.

IVF has a greater chance of multiple pregnancy, even when only one embryo is transferred.

A multiple pregnancy is the greatest risk to your baby when using IVF.

Overall Risks

The first IVF baby was born in 1978. Since then, more than 5 million children around the world have been born through IVF. Studies have shown that these children are quite healthy, in fact, some experts believe having a child through IVF is now just as safe as having a child naturally. Still, one must be careful when making this claim. Infertile couples do not have normal reproductive function, meaning that a baby they have through IVF may have more health problems than a baby conceived naturally.

IVF single babies are often born about 2 days earlier than naturally conceived babies, and are about 5% more likely to weigh less than 5 pounds, 8 ounces (2,500 grams) than a naturally conceived single baby.

IVF twins are not born earlier or later than naturally conceived twins.

The risks of freezing has been checked in animal and human data for several generations. There is no proof that children born from frozen and thawed embryos or frozen and thawed eggs have any more health problems than those born from fresh embryos. Still, it is hard to know for sure if the rate of health problems is the same as the normal rate.

Birth Defects

The risk of birth defects through normal birth is about 4.4 %, and it is about 3% for severe birth defects. In IVF babies, the risk for any birth defect is about 5.3%, while the risk for a severe birth defect is about 3.7%. Most of the increased risk with IVF seems to be due to older mothers and to having infertility. No higher risk is seen in frozen embryo or donor egg cycles.

Imprinting Disorders. These are rare disorders caused by whether the genes from the mother or the genes from the father are working. Studies do not agree on whether these disorders are associated with IVF. Even if they are, these disorders are extremely rare (1 out of 15,000 people). Childhood cancers. Most studies do not suggest any extra risk, except for retinoblastoma (a cancer behind the eye). One study did report an increased risk after IVF treatment, but further studies did not find an increased risk. Infant development. Most studies of long-term developmental outcomes have been reassuring so far. Most children are doing well, however, these studies are hard to complete and have some limitations. A more recent study using better methods shows an extra risk of cerebral palsy and developmental delay, however, this arose mostly from prematurity and low birth weight that was a result of multiple pregnancy.

Risks of a Multiple Pregnancy

More than 30% of IVF pregnancies are multiple pregnancies (twins, triplets, or greater). Identical twins occur in less than 5% of all IVF pregnancies. Identical twins may happen more often after blastocyst (Day 5) transfers, and with assisted hatching of cleavage stage embryo (Day 3) transfers.

Early delivery accounts for most of the problems associated with babies from multiple pregnancies. IVF twins deliver an average of three weeks earlier than IVF single babies, and they weigh about 2 pounds less than IVF single babies. Triplet (and greater) pregnancies deliver before 32 weeks (7 months) in almost half of cases. Fetal growth



problems and unequal growth among the fetuses can also result in perinatal illness and death before or shortly after delivery.

Multiple fetuses that share the same placenta, such as most identical twins, have additional risks. Twin-to-twin transfusion syndrome, where the circulation is not equal between the fetuses, may occur in up to 20% of twins who share a placenta. Twins sharing the same placenta have a higher frequency of birth defects compared to twins with two placentas. Death of one fetus in a twin pregnancy after the first trimester is more common with a shared placenta; this may cause harm to the remaining fetus.

Other problems babies can face include cerebral palsy, retinopathy of prematurity (eye problems that result from early delivery), and chronic lung disease. No one knows how much multiple pregnancies affect neurological or behavioral development, even when none of the other problems occur.

Fetal death rates for single pregnancies are 4.3 per 1,000. For twins, that number is higher at 15.5 per 1,000; and for triplets, the fetal death rate is 21 per 1,000. The death of one or more fetuses in a multiple pregnancy (“vanishing twin”) is more common in the first trimester and may be happen in up to 25% of IVF pregnancies. Loss of a fetus in the first trimester does not usually affect the surviving fetus.

The Option of Multifetal Pregnancy Reduction (Selective Reduction): The more fetuses there are in the uterus, the greater the chance of problems. Patients with twins or more have 3 choices:

Continue with the pregnancy (with all the risks that have already been stated),

End the pregnancy.

Reduce the number of fetuses (terminate one or more of the fetuses) to lower the health risks to mother and remaining fetus(s).

Reducing the number of fetuses lowers the risk of early delivery. This can be a difficult decision to make. The main danger is losing the entire pregnancy. The odds of losing the entire pregnancy are about 1 in 100 (1%). The odds of losing the entire pregnancy are greater if there are more than 3 fetuses present before the procedure is done.

I/We have read and understand the foregoing Risks to Your Baby




Ethical and Religious Considerations in Infertility Treatment

Infertility treatment can raise ethical or religious concerns for some patients. IVF involves the creation of embryos outside the human body. It can also involve the production of extra embryos, and can lead to pregnancy with a high number of fetuses (triplets or more). Patients who have concerns should speak with their counselor or religious leader, or with someone else they trust. This can be a helpful step in infertility treatment.

Psychosocial Effects of Infertility Treatment

Finding out that you or your partner are infertile or have low fertility can be very painful. Infertility and its treatment can affect your emotions, health, finances, and social life. During treatment, you may feel anxious, helpless, depressed, or all alone and go through highs and lows. Be sure to notice if these feelings get severe. In some cases, you may want to seek the help of a mental health expert. Here are some of the warning signs you should watch out for:

Losing interest in the things you usually like to do.

Feeling depressed most of the time.

Strained feelings with your partner, family, friends, or those with whom you work.

Thinking about infertility all the time.

Feeling extremely anxious or nervous.

Having trouble finishing tasks.

Finding it hard to focus or concentrate.

Having changes in your sleep patterns, such as having a hard time falling asleep or staying asleep, waking up early every morning, or sleeping more than normal.

Having a change in your appetite or weight (increase or decrease).

Using drugs or alcohol more than before.

Thinking about death or suicide.

Staying away from other people.

Feeling negative, guilty, or worthless much of the time.

Feeling bitter or angry much of the time. Raising twins or higher multiples may cause physical, emotional, and financial stresses. The chance of having depression and anxiety is higher in women raising multiples. Patients may consider working with mental health professionals who are specially trained in infertility care, as well as with their health care team, to minimize the emotional impact of infertility treatments. National support groups are also available, such as RESOLVE, (www.resolve.org, or Path2Parenthood ((www.path2parenthood.org.org).

Reporting Outcomes

In 1992, the Fertility Clinic Success Rate and Certification Act was passed. This law requires the Centers for Disease Control and Prevention (CDC) to gather information about IVF cycles and pregnancy outcomes in the U.S. each year. This information is used to calculate success rates which are reported each year.

Main Line Fertility Center will report the required information from your IVF procedure to the CDC. Since our Clinic is a member of the Society of Assisted Reproductive Technologies (SART) of the American Society for Reproductive Medicine (ASRM), it will also be reported to SART. Information reported to SART about your cycle may be used for research or quality assessment according to HIPAA guidelines; your name will never be connected to your cycle information in any research that is published by ASRM or SART.

http://www.resolve.org/

http://www.theafa.org/



Research Conducted by SART

Since 2006, the Society for Assisted Reproductive Technology has participated in a series of studies looking at the health of women and children after IVF. Many of these studies are still being conducted. The studies compare women who have not had trouble conceiving and their children with women who used IVF and their children. The studies also compare women who had trouble conceiving but did not do IVF, and their children, to women and their IVF children. IVF children who have siblings form another study group. They are compared with their siblings who were conceived with IVF, conceived with non-IVF fertility treatment, or conceived spontaneously. The items studied are problems related to pregnancy or birth, and the risk of birth defects. Children are also followed to find out if they have developmental delays, problems in school, or increased risk of childhood or adult cancer. You can see the results of many of these studies in the information given below. Results can also be found on the SART website (www.sart.org) under “Research”.

http://www.sart.org/



Additional Information

General IVF overviews available on the internet

www.reproductivefacts.org

www.sart.org/

www.cdc.gov/art/

www.resolve.org/site/PageServer

Effect of Woman’s Age

Female age-related fertility decline. Committee Opinion No. 589. Fertility and Sterility 2014; 101:633-4.

Effect of Number of Oocytes Retrieved

Baker VL, Brown MB, Luke B, Conrad KP. Association of number of retrieved oocytes with live birth rate and birth weight: An analysis of 231,815 cycles of in vitro fertilization. Fertility and Sterility 2015; 103:931-8.

Effect of Infertility Diagnoses

Stern JE, Luke B, Tobias M, Gopal D, Hornstein MD, Diop H. Adverse pregnancy and birth outcomes by infertility diagnoses with and without ART treatment. Fertility and Sterility 2015; 103:1438-45. Luke B, Stern JE, Kotelchuck M, Declercq E, Cohen B, Diop H. Birth outcomes by infertility diagnosis: Analyses of the Massachusetts Outcomes Study of Assisted Reproductive Technologies (MOSART). Journal of Reproductive Medicine 2015; 60:480-490.

Effect of Maternal Obesity

Luke B, Brown MB, Stern JE, Missmer SA, Fujimoto VY, Leach R. Female obesity adversely affects assisted reproductive technology (ART) pregnancy and live birth rates. Human Reproduction 2011; 26:245-252.

Obesity and reproduction: A committee opinion. Practice Committee of the American Society for Reproductive Medicine. Fertility and Sterility 2015; 104:1116-26.

Number of Embryos to Transfer

Elective single-embryo transfer. Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology. Fertility and Sterility 2012; 97:835-42.

Criteria for number of embryos to transfer: a committee opinion. The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology. Fertil Steril 2013; 99(1):44-6.

Practice Committee of the American Society for Reproductive Medicine, and the Practice Committee of the Society for Assisted Reproductive Technology. Guidance on the limits to the number of embryos to transfer: A committee opinion. Fertility and Sterility 2017; 107:901-3.

Culturing Embryos to the Blastocyst Stage

Blastocyst culture and transfer in clinical-assisted reproduction: A committee opinion. The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology. Fertil Steril 2013; 99:667-72.

http://www.reproductivefacts.org/

http://www.sart.org/

http://www.cdc.gov/art/

http://www.resolve.org/site/PageServer



Intracytoplasmic sperm injection

Genetic considerations related to intracytoplasmic sperm injection (ICSI). The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology. Fertil Steril 2006; 86 (suppl 4): S103-S105.

Intracytoplasmic sperm injection (ICSI) for non-male factor infertility: a committee opinion. Practice Committees of the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology. Fertility and Sterility 2012; 98:1395-9.

Wen J, Jiang J, Ding C, Dai J, Liu Y, Xia Y, Liu J, Hu Z. Birth defects in children conceived by in vitro fertilization and intracytoplasmic sperm injection: a meta-analysis. Fertility and Sterility 2012; 97(6): 1331-1337 e4.

Embryo hatching

The role of assisted hatching in in vitro fertilization: a guideline. A Committee opinion. The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology. Fertil Steril 2014; 102:348-51.

Luke B, Brown MB, Wantman E, Stern JE. Factors associated with monozygosity in assisted reproductive technology (ART) pregnancies and the risk of recurrence using linked cycles Fertility and Sterility, 2014; 101:683-9.

Ovarian Hyperstimulation

Prevention and treatment of moderate and severe ovarian hyperstimulation syndrome: a guideline. The Practice Committees of the American Society for Reproductive Medicine. Fertil Steril 2016;106;1634-47.

Luke B, Brown MB, Morbeck DE, Hudson SB, Coddington CC, Stern JE. Factors associated with ovarian hyperstimulation syndrome (OHSS) and its effect on Assisted Reproductive Technology (ART) treatment and outcome. Fertility and Sterility 2010; 94:1399-404.

Risks of pregnancy

Declercq E, Luke B, Belanoff C, Cabral H, Diop H, Gopal D, Hoang L, Kotelchuck M, Stern JE, Hornstein MD. Perinatal Outcomes Associated with Assisted Reproductive Technology: the Massachusetts Outcomes Study of Assisted Reproductive Technologies (MOSART). Fertility and Sterility 2015; 103:888-895.

Risk of borderline and invasive tumours after ovarian stimulation for in vitro fertilization in a large Dutch cohort. FE van Leeuwen, H Klip, et al. Human Reproduction, 2011;26(12):3456-65.

Luke B, Brown MB, Spector LG, Missmer SA, Leach RE, Williams M, Koch L, Smith Y, Stern JE, Ball GD, Schymura MJ. Cancer in women after assisted reproductive technology. Fertility and Sterility 2015; 104:1218-26.

Risks to offspring

Fauser BCJM, Devroey P, Diedrich K, Balaban B, Bonduelle M, Delemarre-van de Waal HA, Estella C, Ezcurra D, Geraedts JPM, Howles CM, Lerner-Geva L, Serna J, Wells D, Evian Annual Reproduction Workshop Group 2011. Health outcomes of children born after IVF/ICSI: A review of current expert opinion and literature. Reproductive BioMedicine Online 2014; 28:162-182.

Multiple pregnancy associated with infertility therapy: an American Society for Reproductive Medicine Practice Committee opinion. Practice Committees of the American Society for Reproductive Medicine Fertil Steril 2012; 97:825-34.

Imprinting diseases and IVF: A Danish National IVF cohort study. Lidegaard O, Pinborg A and Anderson AN. Human Reproduction 2005; 20(4):950-954.

Amor DJ and Halliday J. A review of known imprinting syndromes and their association with assisted reproduction technologies. Human Reproduction 2008; 23:2826-34.



Bergh C, Wennerholm U-B. Obstetric outcome and long-term follow up of children conceived through assisted reproduction. Best Practice & Research Clinical Obstetrics and Gynaecology (2012), doi:10.1016/j.bpobgyn.2012.05.001.

Wennerholm U-B, Söderstöm-Anttila V, Bergh C, Aittomäki K, Hazekamp J, Nygren K-G, Selbing A, Loft A. Children born after cryopreservation of embryos or oocytes: A systematic review of outcome data. Human Reproduction 2009; 24:2158-72. Kopeika J, Thornhill A, Khalaf Y. The effect of cryopreservation on the genome of gametes and embryos: principles of cryobiology and critical appraisal of the evidence. Human Reproduction Update 2015; 21:209-227.

Birth Defects

Källén B, Finnström O, Lindam A, Nilsson E, Nygren K-G, Otterblad PO. Congenital malformations in infants born after in vitro fertilization in Sweden. Birth Defects Research (Part A) 2010; 88:137-43. Davies MJ, Moore VM, Willson KJ, Van Essen P, Priest K, Scott H, Haan EA, Chan A. Reproductive Technologies and the risk of birth defects. N Engl J Med 2012;366:1803-13.

Boulet SL, Kirby RS, Reefhuis J, Zhang Y, Sunderam S, Cohen B, Bernson D, Copeland G, Bailey MA, Jamieson DJ, Kissin DM. Assisted reproductive technology and birth defects among liveborn infants in Florida, Massachusetts, and Michigan, 2000-2010. JAMA Pediatrics 2016; Published online April 04, 2016. doi:10.1001/jamapediatrics.2015.4934

We (I) acknowledge that we have read and understood the information provided above regarding the IVF process and its risks, and agree to go forward with this treatment as our signatures below testify.

Our (my) signatures below also constitutes our(my) acknowledgment that we (I) have read, understood, and agree to the processes, procedures, and risks detailed herein.

We (I) have had the opportunity to ask any questions that we (I) may have regarding the processes/procedures that may be performed, the benefits or purposes of those processes/procedures, the potential complications and associated risks, in addition to the likelihood of achieving the goals contemplated by the processes/procedures detailed herein.

We (I) also acknowledge and understand that Main Line Fertility cannot guarantee or warrant that any of the ART processes/procedures detailed herein will result in a successful pregnancy.

In the event that any provision of this consent is deemed unenforceable as a matter of law, then that provision will be deemed to be deleted, but the rest of this consent will otherwise remain in effect.

SIGNATURE PAGE TO FOLLOW



X Patient Signature Date Patient Name Date of Birth Notary Public Sworn and subscribed before me on this _____ day of _________, __________.

Notary Signature Date -------------------------------------------------------------------------------------------------------------------------

X Spouse / Partner Signature Date Spouse / Partner Name Date of Birth Notary Public Sworn and subscribed before me on this _____ day of _________, __________.

Notary Signature Date ====================================================================================== If signed in the office: Statement by Witness (must be employee of Clinic and at least 18 years of age) I declare that the person(s) who signed this document is/are personally known to me and appear(s) to be of sound mind and acting on their own free will. They signed this document in my presence. ______ Photo ID checked ______Form of photo ID: valid Driver’s License Passport Non-Driver’s License

Patient Partner Witness Name: ____________________________ _______________________________ Witness Signature: ____________________________ _______________________________ Date: ____________________________ _______________________________

of 5 Egg Freezing Informed Consent Form version 2018

Main Line Fertility Center

Egg Freezing Information and Consent Patient Initials: ______________


Egg Freezing

Informed Consent Form

Embryos and sperm have been frozen and thawed with good results for many years. Egg (oocyte)

freezing is a newer technology, therefore there is not as much data available about potential risks.

In some studies, pregnancy rates have been higher when fresh eggs are used compared to frozen eggs.

The rates have also been reported to be higher with frozen embryos rather than frozen eggs.

Good reasons to freeze eggs

Cancer treatment such as chemotherapy, radiation, and/or surgery to reproductive organs.

Elective fertility preservation. The pregnancy rates with egg freezing drop off steeply at age 38

or older.

Absence or lack of adequate sperm to fertilize eggs on the day of egg retrieval procedure.

Some patients prefer to freeze eggs instead of embryos

Some genetic disorders, such as the BRCA mutations, may lead to increased risk for breast and

ovarian cancer and possible early removal of ovaries. It is unclear if genetic disorders might

cause genetic problems in the child.

Early menopause or premature ovarian failure

Egg Freezing Process

Vitrification (fast freezing) of eggs involves freezing the eggs obtained from the egg retrieval procedure. The surrounding cumulus cells will be removed from the eggs, and the eggs will be assessed for maturity. Typically, only mature eggs will be vitrified. The embryologists will move the eggs through several drops of cryoprotectant solutions (solutions that contain substances that protects damage to cells during freezing), place onto a device, plunge into liquid nitrogen, where they will be stored in cryostorage tanks until you are ready to thaw the eggs in the future.

Thawing Frozen Eggs Eggs may only be thawed only after you sign the Egg Thaw Authorization form for each future egg

thaw. The signature/s must be notarized by a Notary Public or witnessed by a Main Line Fertility

employee.

Eggs that are determined by MLFC to be of poor quality or unsuitable for future attempts at pregnancy

will be discarded.

After thawing, each egg will be examined to determine if it is suitable for intracytoplasmic sperm

injection (ICSI). ICSI must be performed on all thawed eggs due to the changes of the egg’s zona

pellucida (shell). Thawed eggs will not fertilize by standard insemination.





Intracytoplasmic Sperm Injection (ICSI)

ICSI does not guarantee normal fertilization.

There may be an increased risk of genetic problems in children born from ICSI.

ICSI will not improve any defects in the eggs.

ICSI involves the injection of a single sperm into the interior of an egg using an extremely thin glass needle. The sperm must be healthy, and the egg must be mature. ICSI is utilized after thawing eggs.

ICSI may be associated with a slightly higher risk of birth defects. The risk of birth defects after ICSI is still quite low (4.2% compared with 3% in children conceived naturally). Experts are still debating the impact of ICSI on the mental and physical development of children. Most recent studies have not detected differences in the development of children born after ICSI, regular IVF, or natural conception.

The eggs that fertilize will be cultured in a lab incubator for 3 to 5 days to determine which one/s will

develop into the best quality embryo/s. The physician will determine which embryo/s are deemed

suitable for transfer to the uterus.

Extra good quality embryos will be vitrified, if applicable. In the future, frozen embryos will be

thawed only after you and your partner (if applicable) sign the Embryo Thaw Authorization form

for each frozen embryo transfer cycle. The signature/s must be notarized by a Notary Public or

witnessed by a Main Line Fertility employee.

Embryos that are determined to be of poor quality or unsuitable for future attempts at pregnancy will

be discarded.

Possible risks of the procedure

Not all eggs will survive the freezing and thawing process

Not all eggs that survive the thawing process will fertilize

Not all fertilized eggs (embryos) will develop into an embryo suitable for transfer to the uterus

(womb)

Not all transferred embryos will result in a pregnancy

When eggs are vitrified, they may come in contact with liquid nitrogen. Theoretically, this may

cause a possible risk of infection if the liquid nitrogen has been infected by a micro-organism,

however there has never been an infection reported this way.

There is currently no scientific evidence that the freezing, storing and thawing of the eggs adversely

affects the embryo, however there may be abnormalities associated with the use of frozen eggs that

are not yet known.





Is there any risk to children conceived from the use of frozen eggs?

A large study of mainly the slow freeze method looked at the risk to children conceived from the use of

frozen eggs. It showed that there was no extra risk of birth defects compared to most births in the

USA. A second study was done on the vitrification (fast-freeze) method. It showed no significantly

higher risk of birth defects or low birth weight (less than 5 ½ pounds) compared to children born after

IVF cycles using fresh eggs. Not much is known about children born after egg freezing in older women.

There is also no data on follow-up years after birth.

Summary

Egg freezing is no longer classified as new or experimental by the American Society of

Reproductive Medicine (ASRM)

Pregnancy rates may be lower with frozen eggs than with fresh eggs

Younger women who freeze their eggs are expected to have better success rates than older

women who freeze their eggs

There are many good reasons to support freezing eggs rather than embryos, including but not

limited to the following: elective egg freezing, ethical concerns, lack of sperm available for

insemination, fertility preservation prior to cancer treatment, and presence of genetic

disorders.

Women who freeze eggs in order to have a child later in life should be aware of the limited

data about success rates

Alternatives

I may choose not to freeze my eggs.

Agreement regarding storage and disposal of the eggs

I/We hereby understand and agree that before eggs will be vitrified, I/We must execute additional

consents/directives with MLFC with respect to the terms and conditions of the eggs’ storage, transfer,

disposition, and disposal. I/We have been provided with a copy of the Agreement and understand that

this is a legally binding document. I/We fully understand the Agreement’s provisions and have had the

opportunity to have questions answered prior to signing this agreement. I/We do acknowledge that

I/We have been afforded the opportunity to consult with independent legal counsel regarding any

specific legal questions/concerns.

Patient Signature __________________________ Partner Signature _________________________

Patient Name _____________________________ Partner Name ____________________________

Date _____________________ Date __________________________





Financial

I/We have had the opportunity to fully discuss the financial and insurance coverage issues relating to

this procedure with MLFC. I/We agree to be responsible for all expenses related to this procedure,

including all charges not covered by our insurance. Patients and partners will continue to be

responsible for all unpaid cryostorage fees even if eggs or embryos are discarded.

I certify that I have read the foregoing or it has been read to me, that I fully understand the contents,

and that all of my questions have been answered to my satisfaction.



Date _____________________ Date __________________________

Risks of Storage

Foreseen and unforeseen circumstances (e.g. natural disasters, storage tank malfunctions, equipment

failure, and power loss) may cause the egg(s) to thaw, be damaged, and/or not survive. We understand

that under no circumstances will MLF/MLFC reimburse any payments made towards frozen egg or

embryo storage in the event of a loss due to the aforementioned events. We agree to absolve, release,

indemnify, protect and hold harmless Main Line Fertility and their respective members, medical staff,

managers, agents, and employees in event that any embryo and/or egg(s) frozen and stored with

MLF/MLFC are damaged or destroyed as a result of the events detailed herein, or other potential

unforeseen circumstance.



Date _____________________ Date __________________________

Consent

I have read and understood the information provided regarding the egg freezing process and its risks. I

hereby request, consent to, and authorize the Main Line Fertility Center and its employees to perform

the freezing of my eggs in conjunction with my ART procedure. In authorizing this procedure, I

acknowledge having received and signed the Assisted Reproductive Technology (ART) – Risk and

Consent and the Disposition of Eggs Consent forms. I have had the opportunity to discuss fully with a

Physician the nature and purpose of this procedure, the risks and benefits, and my other options

relating to disposition of my eggs.





By signing below, I confirm the choices I have made in this agreement. I understand that I can

change those choices in the future. This will require a written and notarized agreement. I/we

acknowledge that I/we have read and understood the information provided above regarding

the egg freezing and storage process and its risks, and I/we agree and consent to freezing of

my eggs by the Main Line Fertility Center as my signature/s below testifies:

X Patient Signature Date Patient Name Date of Birth Notary Public Sworn and subscribed before me on this _____ day of _________, __________.

Notary Signature Date -------------------------------------------------------------------------------------------------------------------------

X Spouse / Partner Signature (if applicable) Date Spouse / Partner Name (if applicable) Date of Birth Notary Public Sworn and subscribed before me on this _____ day of _________, __________.

Notary Signature Date ====================================================================================== If signed in the office: Statement by Witness (must be employee of Clinic and at least 18 years of age) I declare that the person(s) who signed this document is/are personally known to me and appear(s) to be of sound mind and acting on their own free will. They signed this document in my presence. ______ Photo ID checked ______Form of photo ID: valid Driver’s License Passport Non-Driver’s License

Patient Partner Witness Name: ____________________________ _______________________________ Witness Signature: ____________________________ _______________________________ Date: ____________________________ _______________________________

of 6 Disposition Eggs Consent Form version 2018 Main Line Fertility Center

Disposition of Eggs Consent Form Patient Initials: ______________


Disposition of Eggs Consent Form

I have chosen to have my eggs retrieved from my ovaries. I may use my eggs when they are removed or at some time in the future. This consent covers both fresh eggs and those that may be frozen. If I do not use my eggs—due to my death or some other reason—I have 4 choices:

1. Give control of my egg(s) to my partner or spouse (if applicable); 2. Discard the frozen egg(s); 3. Donate the frozen egg(s) for approved medical research studies; or 4. Donate the frozen egg(s) to another couple so they can try to have a child

In making one of the above choices on this form, I understand that I can change my choice at any time if I fill out and sign a new version of this consent. I am aware that I will need to sign a different consent when my eggs are used.

I am aware that my marital status—now and later—may affect use of these eggs if they have been combined with sperm to create embryos. I am also aware that each clinic and each state have their own policies which may affect my ability to use these eggs if they have been combined with sperm to create embryos.

**In the event these eggs are to be combined with sperm to create embryos, additional consents/agreements will be required prior to the creation of any said embryos.**

MY CHOICE:

If I die before using all of my eggs . . . (check only one box):

Please give control over the use of my eggs to my spouse or partner. He or she will have complete control for any purpose. This includes implantation for purposes of them parenting any resulting child, donation for medical research, or discard. This may mean keeping the frozen eggs in storage. It may also mean that Main Line Fertility Center (MLFC) will be owed payment. Donate my eggs to an unknown couple or person who wishes to have a child. This process is controlled by the FDA (U.S Food and Drug Administration) and state laws, meaning that means that both partners may need to have undergone special FDA testing.

Donate my eggs to the couple or person named below. I know that this choice is controlled by the FDA and state laws, meaning that means that both partners may need to have undergone special FDA testing.

Donate to: Name ________________________________




Address ________________________________

_______________________________________

Phone ________________________________ Email ________________________________

Note: If the couple or person named above cannot or will not accept the eggs, MLFC will discard the eggs.

Donate my eggs to medical research, which may include thawing of the eggs and/or any resulting embryos. I accept that this choice will not result in the birth of a child. I also understand that this donation may be restricted by state or federal laws where I live, and it is up to me to check the laws about donating eggs to research.

Discard the eggs.

In the event of my death, prior to utilizing all of the eggs retrieved, it is my intent that this Consent controls the disposition of eggs, however, I understand that this consent is not a Last Will and Testament and therefore additional legal requirements may be necessary to effectuate the disposition selected herein.

Nonpayment for storing frozen eggs

Keeping egg(s) frozen requires that I pay annual storage fees. I must also contact MLFC at least once a year to verify address and contact information. My eggs may be discarded if:

I have not contacted MLFC for 3 years

I have not paid storage fees for 3 years, and MLFC cannot reach you Before discarding the eggs, MLFC will contact you by registered mail at your last known address. You must pay the overdue storage fees within 30 days from the date of the mailing. If you do not, you are giving your permission for MLFC to take the step below. Further contact will not be attempted. (Check one box only):

Donate my eggs to medical research. I accept that this will not result in the birth of a child. Discard the eggs.

Patients and partners (if applicable) will continue to be responsible for all unpaid cryostorage fees even if eggs or embryos are discarded.

I/We also agree that if: our selected disposition choice is not available or, in the MLFC’s sole discretion, is not practical to implement; if I/we do not uphold our obligation to pay all storage and storage related fees when due; or fail to preserve any choice we have made here as required by this Agreement or MLFC, I/we authorize MLFC to discard my eggs (or our embryos). Patients and partners, and/or their estate, will continue to be responsible for all unpaid cryostorage fees if eggs or embryos are discarded.




Time-Limited Storage of Frozen Eggs

MLFC will keep frozen eggs for a maximum of 10 years. Beyond that time frame, I choose to (check one box only):

Donate my eggs to medical research. I accept that this will not result in the birth of a child. Discard the eggs. Pay and arrange for the eggs to be moved to an offsite storage facility.



Date _____________________ Date __________________________

Age-Limited Storage of Frozen Eggs

I accept that MLFC will not use (thaw) my eggs to help me attempt pregnancy after age 60. After this age, I choose to (check one box only):

Donate my eggs for medical research. I accept that this will not result in the birth of a child. Donate my eggs for clinical training or use. Discard the eggs. Pay and arrange for the eggs to be moved to an offsite storage facility or another Fertility Clinic. Donate the eggs to another couple who want to have a child.



Date _____________________ Date __________________________

What you should know about donating frozen eggs for research

If you chose “Donate my eggs to medical research”, you should know that:




We may not be able to find the right research project for your eggs. If no project can be found, or your eggs are not appropriate for research your egg(s) may be discarded.

Your privacy will be protected. No one will know the eggs are yours. You will not receive any facts about the research project that uses your eggs. You will receive no money for donating your eggs to research. You will receive no medical benefit for donating your eggs to research. Any embryos formed with your eggs will not be transferred to a woman’s uterus.

Thawing Frozen Eggs and Future Frozen Embryos Eggs are stored in liquid nitrogen tanks until you are ready to thaw the eggs in the future.

Eggs will be thawed only after you sign the Egg Thaw Authorization form for each egg

thaw cycle.

Frozen embryos will be thawed only after you and your partner (if applicable) sign the

Embryo Thaw Authorization form for each frozen embryo transfer (FET) cycle. These

authorization forms must be notarized by a Notary Public or signed in front of a Main Line

Fertility employee.

Eggs and embryos that are determined by MLFC to be of poor quality or unsuitable for future

attempts at pregnancy will be discarded.



Date _____________________ Date __________________________

Risks of Storage Foreseen and unforeseen circumstances (e.g. natural disasters, storage tank malfunctions,

equipment failure, and power loss) may cause the egg(s) to thaw, be damaged, and/or not survive.

We agree to absolve, release, indemnify, protect and hold harmless Main Line Fertility and their

respective members, medical staff, managers, agents, and employees.

We understand that under no circumstances will MLF reimburse any payments made towards

frozen embryo or egg storage in the event of a loss due to the aforementioned events. We agree to

absolve, release, indemnify, protect and hold harmless Main Line Fertility and their respective

members, medical staff, managers, agents, and employees in event that any embryo and/or egg(s)

frozen and stored with MLF are damaged or destroyed as a result of the events detailed herein, or

other potential unforeseen circumstance.




Patient Signature ______________________ Partner Signature _________________________

Patient Name ________________________ Partner Name ____________________________

Legal Issues and Legal Counsel

I understand that:

The laws on egg freezing, thawing, and use may be unclear where I live. They may also be unclear on the parent-child status of any resulting child(ren). MLFC has not given me any legal advice, and I am not relying on them to do so. I may need to speak to a lawyer who is an expert in this area to understand my legal rights and obligations. In the event my eggs are combined with sperm to form embryos, my marital status may affect my ability to use the embryos in the event of a dispute. The policy of MLFC or state may also affect my ability to use my eggs.

By signing below, I confirm the choices I have made in this agreement. I understand that I can change those choices in writing in the future, which will require a written and notarized agreement as outlined above. I also understand that if none of my choices are available, MLFC may discard my frozen eggs.




I acknowledge that I have read and understood the information provided above regarding the egg disposition, and agree and consent to disposition of eggs by the MLFC as our signatures below testify:

X Patient Signature Date

Patient Name Date of Birth

Notary Public Sworn and subscribed before me on this _____ day of _________, __________.

X Notary Signature Date ====================================================================================

If signed out of the office: Statement by Witness (must be employee and at least 18 years old) I declare that the person who signed this document is personally known to me and appears to be of sound mind and acting of their own free will. They signed this document in my presence. ______ Photo ID checked ______ Form of photo ID: valid Driver’s License Passport Non-Driver’s License Witness Name: ________________________________________________________________ Witness Signature: ________________________________________________________________ Date: ________________________________________________________________

IVF Egg Freeze Orientation Packet · 2019. 3. 7. · o IVF Procedure CPT Codes: 89280, 89281,...

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Transcript of IVF Egg Freeze Orientation Packet · 2019. 3. 7. · o IVF Procedure CPT Codes: 89280, 89281,...