2016_05_23_FINAL Extend Fertility Egg Freezing Consent Form

INFORMED CONSENT FOR OVARIAN STIMULATION, EGG RETRIEVAL
and OOCYTE CRYOPRESERVATION (EGG FREEZING)
I.
OVERVIEW
I have elected to cryopreserve (freeze) my oocytes (eggs) through services provided by
Extend Fertility, LLC and Extend Fertility Medical Practice. Prior to starting the oocyte
cryopreservation (egg freezing) process, I have received all of the required screening tests
and provided them to Extend Fertility Medical Practice.
Egg freezing involves taking medication for about 1–2 weeks, as determined by my
physician, to stimulate my ovaries to produce multiple eggs, as well as multiple blood tests
and transvaginal ultrasound exams. These eggs will then be surgically removed from my
body, frozen in a laboratory, and stored in a specialized storage facility. Freezing my eggs
will give me the option of using them in the future.
If I choose to use my frozen eggs in the future, they will be thawed and fertilized in a
laboratory, creating embryos in a process called in vitro fertilization (IVF). The resulting
embryos could then be transferred into my uterus in the hopes of achieving a pregnancy. If
and when I decide to use my frozen eggs, I will need to read and sign a separate consent
form outlining the procedures and risks of IVF and embryo transfer (ET).
II.
WHAT IS THE PURPOSE OF EGG FREEZING AND HOW CAN IT BENEFIT ME?
Egg freezing may be an effective method for preserving reproductive capacity. Women
experience a progressive loss of egg quantity and quality as they age; in particular, the rate
of infertility, pregnancy loss, and chromosomal abnormalities increases as a woman ages.
Therefore, delaying childbearing can have a significant effect on a woman’s ability to
conceive and deliver a healthy baby. Freezing eggs gives women the chance to avoid the
age related effects on those frozen eggs.
III.
HOW ARE THE EGGS REMOVED FROM MY BODY?
After ovarian stimulation is complete, my eggs will be retrieved from my ovaries in a surgical
procedure called “transvaginal ultrasound-guided follicular aspiration,” commonly known as
the egg retrieval. The procedure usually takes about 15 minutes. I will be given anesthesia
through an intravenous line so that I will be asleep and will not feel pain during the
procedure. I will be asked to sign a separate consent form on the day of my surgical
procedure for the use of anesthesia. A vaginal ultrasound probe will enable the physician to
see my ovaries, and a thin needle attached to the ultrasound will be inserted through the
vaginal wall and into the ovaries to retrieve the eggs. Afterwards, I will be observed in the
recovery area until the sedative effects of anesthesia have cleared my system, typically for
about 30–60 minutes, before I can leave.
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IV.
WHAT ARE THE POSSIBLE RISKS?
1. Reproductive risks
Although oocyte cryopreservation is accepted as a safe and effective method of fertility
preservation, some studies have shown that it may not be as effective at achieving a
pregnancy as using a “fresh” (never frozen) oocyte in IVF. Freezing my eggs does not
provide a guarantee that the eggs, once thawed, will result in an embryo or a viable
pregnancy. There is a risk that, should I choose to use my eggs in order to become
pregnant, none of my eggs will survive the thawing procedure, fertilize normally, or develop
into embryos. There is also the chance that even if an embryo is transferred to my uterus, it
may not result in a pregnancy, or it may result in a pregnancy that is abnormal (pregnancy
loss, miscarriage, a baby with a chromosomal abnormality or a congenital defect).
While short-term data on egg freezing are reassuring, long-term data on developmental
outcomes and safety data in diverse (older) populations are lacking. Therefore, the effect of
freezing my eggs on the development of my baby and the rate of miscarriage with an embryo
created from a frozen egg is not known with certainty.
2. Medication risks
A. Ovarian Hyperstimulation Syndrome (OHSS)
Occasionally, the ovarian stimulation medications stimulate the ovaries more than
desired, resulting in a variety of symptoms known as OHSS. This syndrome occurs in a
minority of women who use the medications. OHSS leads to swelling and enlargement
of the ovaries and the release of fluid into the abdominal cavity. There are varying forms
of OHSS:
•
Mild OHSS is the most common form of OHSS (up to 25% incidence) and can be
associated with abdominal discomfort, pressure and swelling, which typically
resolves within 1–2 weeks.
•
Moderate OHSS (up to 5% incidence) symptoms are more pronounced and may
require careful monitoring, temporary bed rest, and pain medication.
•
Severe OHSS is rare (<1% incidence), but could cause serious medical
complications including ovarian torsion (twisting of the ovary) or blood clots. In
these cases, hospitalization may be necessary. In an extreme case, the condition
could be life-threatening and/or require surgical treatment, including surgical
removal of an ovary. My cycle may need to be cancelled if my physician
determines that I am at risk for developing Severe OHSS.
B. Cycle Cancellation
In addition to cancellation in the case of Severe OHSS, my cycle may be cancelled if the
development of the eggs is not adequate, if the development of the eggs proceeds too
slowly, if the eggs are released into the abdominal cavity prematurely (prior to the
retrieval), or in the case of other medical problems that may make it inadvisable to
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proceed with the retrieval. The chance of cancellation prior to retrieval once stimulation
has begun is typically less than 10–20%.
C. Side effects
In a minority of patients (20% or less), medications used during stimulation can cause
hormone fluctuations which may be associated with headaches, mood swings, insomnia,
hot/cold flushes, breast tenderness, abdominal bloating, and/or mild fluid retention.
The medications involved in the egg freezing process are given by injection. Women
using these medications may develop soreness, redness, or mild bruising around the
injection site. Very rarely, a woman may experience fainting or have an allergic reaction
to the medication.
D. Pregnancy
When I am taking ovarian stimulation medications, it is possible that I could become
pregnant, and have a high-order multifetal pregnancy, if I have unprotected sexual
intercourse. I agree to either abstain from sexual intercourse or use barrier
contraceptives (e.g. condoms) during the egg freezing process.
3. Egg Retrieval Procedure Risks
V.
A.
Eggs are retrieved by ultrasound-guided transvaginal follicular aspiration, described
above. After the needle is inserted into the ovary, there may be bleeding. Although it
happens very rarely (<1/1000 incidence), there is a risk of damage or puncture to the
bowel, bladder, nearby blood vessels, uterus, ovaries, or fallopian tubes during egg
retrieval. In the unlikely event of severe internal bleeding or serious damage to pelvic
organs, abdominal surgery may be needed.
B.
It is possible to develop an infection after the procedure, typically treated with a course of
oral antibiotics, but rarely requiring intravenous treatment and/or hospitalization and
surgery.
C.
After the procedure, I may experience moderate discomfort or pain for 24–48 hours.
Rarely, more significant discomfort persists for several days.
D.
I will be monitored through hormone blood tests and transvaginal ultrasounds to predict
egg maturity, but I understand that such tests are not 100% accurate. Even with the most
careful evaluation, eggs may not be retrieved or eggs that are retrieved may not be at the
appropriate stage of development to be cryopreserved.
HOW WILL MY FROZEN EGGS BE STORED?
Extend Fertility, LLC will store my frozen eggs at Manhattan Fertility Services, 1625 Third
Ave., Suite LL, New York, NY 10128 for up to the first six months of storage beginning on the
date of my egg retrieval procedure (“Initial Storage Period”), at no additional cost.
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1625 Third Ave. Suite LL.
New York, NY 10128
212-810-2828
www.extendfertility.com
At the time I sign this Consent, I must also elect a long term storage plan by signing a
separate agreement (the “Long Term Storage Agreement”) for how my frozen eggs with be
stored after the Initial Storage Period. There are additional fees associated with the long
term storage.
If I do not sign the Long Term Storage Agreement, Extend Fertility, LLC reserves the right to
discontinue storage of my frozen eggs and may, after the required notice period, and in its
sole discretion, arrange for the destruction of my frozen eggs such that they cannot and will
not be used for reproductive purposes by or on behalf of any person(s).
VI.
WHAT WILL BE DONE WITH THE EGGS THAT ARE NOT FROZEN?
Any eggs obtained during my egg retrieval procedure that are determined by embryology
staff to be unsuitable for freezing (immature and/or unhealthy) will be disposed or used for
quality control and/or training purposes. When Extend Fertility, LLC disposes of such tissues
and fluids, it will be done in accordance with its policies.
VII.
HOW CAN I HAVE MY FROZEN EGGS RELEASED TO ME OR TO A PLACE I
DESIGNATE?
If and when I choose, I may authorize Extend Fertility, LLC to release my frozen eggs to a
licensed physician or clinic designated by me, in accordance with my signed written
authorization. I understand that Extend Fertility, LLC may choose not to honor any
instruction or document (other than my signed authorization) that purports to give any person
other than me any interest in or right to direct or discard any of my frozen eggs.
VIII.
WHAT WILL HAPPEN TO MY FROZEN EGGS IF I DECIDE NOT TO USE THEM OR
WANT TO DONATE THEM?
This consent does not provide for disposition of my frozen eggs other than due to my
death or nonpayment of egg storage.
In order to donate my frozen eggs to a specific person, now or at any time in the future, I
must sign a separate agreement (the “Egg Donation Form”) and undergo additional
screening and testing prior to egg retrieval and incur additional costs associated with the
screening and testing.
If I no longer plan to use my eggs for my own fertility purposes, I will provide written notice to
Extend Fertility, LLC indicating my wishes and executing any required forms.
IX.
WHAT ARE THE LEGAL CONSIDERATIONS?
I hereby agree to indemnify, hold harmless, not sue, and release the Extend Fertility Medical
Practice and its physicians, employees, and contractors, and Extend Fertility LLC, and any of
its officers, directors, trustees, employees, or agents, and any other individuals in connection
with any and all liability or obligation of any kind whatsoever in any manner connected with or
related to my participation in this egg freezing process, including but not limited to: (1) failure
to become pregnant; (2) pregnancy with subsequent miscarriage; or (3) complications of
pregnancy.
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1625 Third Ave. Suite LL.
New York, NY 10128
212-810-2828
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X.
WHAT ARE THE FEES?
There are fees associated with ovarian stimulation, egg retrieval and oocyte cryopreservation
and that these fees are my responsibility. These fees have been explained to me. It is my
responsibility to contact the Extend Fertility, LLC billing with questions regarding the fees.
I also understand that there will be additional fees associated with the long term storage of
my frozen eggs, outlined in the Long Term Storage Agreement.
XI.
WHAT WILL HAPPEN TO MY FROZEN EGGS IN THE EVENT OF MY DEATH?
My preference is indicated by a check mark on the appropriate line below:
______ I authorize Extend Fertility, LLC to discard all my frozen eggs, in accordance with its
policies for discarding frozen eggs so that they cannot and will not be used for reproductive
purposes by or on behalf of any person(s).
OR
______ I authorize Extend Fertility, LLC to donate my frozen eggs in accordance with my
signed Egg Donation Consent form.
If I decide to change my wishes concerning the disposition of my frozen eggs, a notarized
notice must be provided to Extend Fertility, LLC.
ACKNOWLEDGEMENT AND CONSENT
By signing below,(a) I acknowledge that I have read this Egg Freezing Consent Form; (b) I have
been encouraged to ask questions, and that the questions I have asked have been answered to my
satisfaction; and (c) I consent to freezing my eggs in accordance with this Egg Freezing Consent
Form.
______________________________________
Signature of patient
___________
Date
_____________________________________
Name of patient (printed)
WITNESS’S SIGNATURE
_____________________________
Signature
___________________
Date
_____________________________
Print Name/Title
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Authorization for Release of Health Information
What about privacy?
Certain of your health information, including your first and last name, screening and testing
information, date of retrieval, and other information contained in your medical record, including HIV
related information,1 which will be gathered by Extend Fertility Medical Practice as part of the egg
stimulation and retrieval process will be disclosed to Extend Fertility, LLC, which is providing the egg
freezing and egg storage services. Extend Fertility, LLC may also share this information with the
long term storage companies with which it contracts. You have the right to review the Extend
Fertility Medical Practice’s Notice of Privacy Practices before you sign this authorization.
How long does this authorization last?
The authorization to release your information will automatically expire when Extend Fertility, LLC is
no longer providing storage for your frozen eggs. You can revoke this authorization at any time by
notifying ___________ in writing at: ____________________. If you revoke this authorization, your
revocation won’t be effective until after it is received and logged by Extend Fertility Medical Practice.
Any use or disclosure of your information made before you revoke in writing will not be affected by
your revocation.
Your signature at the bottom of form shows that you acknowledge and agree to the following:
I understand that this authorization for the release of health information will be in effect as long as I
am receiving egg freezing services from Extend Medical Practice and Extend Fertility, LLC, or until I
cancel it in writing.
I acknowledge receipt of the Notice of Privacy Practices.
____________________________
Client Signature
____________________________
Client Printed Name
_________
Date
Updated: 5/23/16
Created: 2/8/16
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The recipient of my HIV-related information is prohibited from redisclosing such information without my
authorization unless permitted to do so under federal or state law. I understand that I have the right to request a list
of people who may receive or use my HIV-related information without authorization. If I experience discrimination
because of the release or disclosure of HIV-related information, I may contact the New York State Division of
Human Rights at (212) 480-2493 or the New York City Commission of Human Rights at (212) 306-7450.
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1625 Third Ave. Suite LL.
New York, NY 10128
212-810-2828
www.extendfertility.com