Download long term risks of fertility drugs

NASHVILLE FERTILITY CENTER, P. C.
345 23rd Ave. North, Suite 401, Nashville, TN 37203 (615) 321-4740 FAX (615) 320-0240
CONSENT FOR ANONYMOUS DONATION OF OOCYTES
I have agreed to be an egg donor for an anonymous recipient. I understand that fertility drugs
will be used to stimulate my ovaries so that multiple eggs may be obtained. I have been informed about
the possible association between fertility drugs and ovarian cancer in infertile women. I understand that
there are no long-term studies looking at possible adverse effects of these drugs in individuals like
myself undergoing egg donation. I understand that the removal of the eggs requires the placement of a
needle through my vagina and into my ovaries. This procedure has risks that include bleeding and / or
infection. In rare instances, bleeding may be so severe that it would require blood transfusion and /or
surgery to repair. It is possible that this would impair my future fertility. Pelvic infection may require
treatment with antibiotics and/or surgery. This may also lead to impairment of future fertility.
Enlargement of the ovaries (ovarian hyperstimulation syndrome) may occur prior to or following the egg
retrieval. As a result of this enlargement, ovarian torsion (twisting of the ovary on its blood supply) may
occur. This requires surgical treatment and may result in the loss of an ovary, and would subject me to
all of the risks associated with major surgery including the risks of anesthesia (even death), bleeding,
infection and damage to internal organs such as bowel, bladder or uterus.
The following is a general outline of the steps that may be required in these procedures.
1. Determination by standard tests that I am a suitable candidate for the procedure.
2. The use of “fertility” drugs (including, but not limited to, Clomid, Serophene, Lupron,
Pergonal, Follistim, Gonal-F, Menopur, Bravelle, Repronex and hCG) to produce ovulation, or
release of the egg(s), at a predictable time. Collection of the egg(s) will be scheduled to occur
just before the predicted release. I have read and understand the consent form entitled “Ovulation
Induction for IVF.
3. The use of blood tests taken to monitor growth of the follicle(s) containing the egg(s). About
10-15 cc (2-3 teaspoons) of blood will be taken each time blood is drawn.
4. The performance of ultrasound examinations to assist in predicting the time of expected
ovulation. Ultrasonography is a diagnostic procedure using sound waves that provide an
“image” of the ovaries and the growing follicle(s).
5. Undergoing aspiration of the egg(s) from the follicle(s) in the ovary which may be done by
one or more of the methods below:
a. Ultrasound-guided transvaginal aspiration of egg(s) through a needle directed along
side the vaginal probe and into the follicle. During the egg aspiration procedure, it
may not be technically possible to remove all the eggs with the ultrasound-guided
technique.
I understand that the following are some of the more common, but not all of the risks and discomforts
associated with this procedure:
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1. From the blood drawing and injections, mild discomfort and a risk of developing a bruise at
the needle site, or a blood clot.
2. From the ovarian hyperstimulation drugs, the possible development of over stimulation of the
ovaries which may cause discomfort because more than one follicle is growing. In addition, the
possible increased risk of developing ovarian cancer later in life as well as other risks as outlined
in the “Ovulation Induction for IVF” consent form. Several publications have suggested that
there may be long term risks associated with the use of fertility drugs. In particular, early
studies, suggest that women who take fertility drugs may have an increased risk of developing
ovarian cancer. While more recent studies have cast doubt on these claims, you still need to be
aware of this concern. The magnitude of this risk and the definition of which patients may be at
risk are still under study. More basic and epidemiologic research is needed to define whether
this is a true association, which drugs are implicated, and which patients may be at risk. I have
read and understand the above mentioned consent forms.
3. Since your Estradiol (estrogen) level will be increased by the ovarian hyperstimulation, you
are at increased risk for developing a blood clot. This can be a very dangerous situation that can
result in a pulmonary embolus (blood clot to the lung), heart attack, or stroke. This could result
in additional hospitalization and medical treatment.
4. From the transvaginal ultrasound-guided aspiration or the laparoscopy, (a) possibility of
bleeding, infection or injury to the abdominal organs that may require immediate major surgery.
(b) The risks associated with the anesthesia (general, local or sedation), including death.
5. Psychological stress.
The nature of Assisted Reproductive Technology (ART) procedures has been explained to me, together
with the known risks. I understand the explanation that has been given to me. I have had the
opportunity to ask my physician any questions I might have and those questions have been answered by
him / her to my satisfaction. Any future questions I have may be addressed to the Nashville Fertility
Center staff, or to the Nashville Fertility Center Director and ART Program Director, Dr. George A.
Hill at (615) 321-4740. I acknowledge that the ART procedure is being performed at my request and
with my consent. I understand that I may revoke my consent at any time prior to the beginning of this
procedure and that this decision would not affect any other present or future medical care and treatment
at Nashville Fertility Center
I expect this procedure to be performed with not less than the customary standard of care. I understand
the risks and benefits as outlined, and further understand and agree that Nashville Fertility Center shall
be responsible only for acts of negligence on its part and the part of its officers, employees and
authorized agents. There are risks associated with any medical treatment for infertility, and these risks
must be weighed against the benefit expected from that treatment. Please ask us any questions you may
have regarding this.
If complications occur which require medical treatment, these charges would be filed to my health
insurance. Nashville Fertility Center (NFC) is not liable for any lost wages that are a result of my
involvement in the egg donation program even if complications occur. I understand I should use a
barrier method of contraception or abstinence while I am participating in the egg donation program to
reduce or eliminate the possibility of becoming pregnant.
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I am being compensated for my time while being a participant in the egg donor program. If I am unable
to continue to the point of egg retrieval, due to no fault of my own, my compensation will be prorated as
determined by Nashville Fertility Center. The pro rata share will be determined as follows: if
cancellation occurs after I start therapy with Lupron but prior to starting FSH therapy, I will receive 15%
of the compensation; if cancellation occurs after starting FSH but prior to egg retrieval, I will receive
40% of the compensation; and if I undergo the egg retrieval then I will receive 100% of the
compensation. I understand that I am not an employee of Nashville Fertility Center and nothing in this
agreement is meant to imply that an employer-employee relationship exists. As an egg donor, I am
considered an independent contractor and will receive an IRS form 1099 from Nashville Fertility
Center at the end of each year. I will consult with my tax advisor regarding the reporting of this
income.
I have read the above, understand the risks, and agree to participate as an egg donor under the terms
listed above. I have had my questions answered. I agree to the administration of drugs for stimulating
ovulation and will follow the administration instructions given to me by the NFC physician or nurse.
I understand that upon donation of my eggs, I relinquish all legal rights to any embryos or children that
are born as a result of this egg donation. I will not be able to receive any identifying information about
these children or embryos or about the recipients of the embryos that result from these donated eggs. No
identifying information about me will be given to the recipient couple or to any children who are born as
a result of this donation.
I understand that my eggs may be donated to more than one recipient. This does not change my
compensation given that I am being compensated for my time in the process of egg donation. I
understand that the decisions regarding disposition of the frozen embryos, including but not limited to
discarding or donation of the embryos to another infertile patient will be made by the recipient and
recipient’s partner. The options available to the recipients are a follows:
A. To keep frozen embryos in storage for future use in a frozen embryo transfer cycle to attempt
pregnancy for themselves.
B. Discard remaining embryos.
C. Donation of frozen embryos to an anonymous recipient.
All of my questions regarding this procedure and its risks and potential complications have been
answered to my satisfaction.
This agreement will be governed by and construed in accordance with the laws of the state of Tennessee,
which is the place of operation of Nashville Fertility Center, P.C. (NFC).
__________________________________
__________________________________
________
Name (typed or printed)
Signature
Date
_____________________________________________
________________________
IVF Nurse Coordinator
Date
_____________________________________________
________________________
Physician
Date
Anonymous Egg Donor Consent 2009
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NASHVILLE FERTILITY CENTER, P.C.
345
23rd
Ave. North · Suite 401 · Nashville, TN 37203 · (615) 321-4740
OVULATION INDUCTION FOR IVF OOCYTE DONOR
FSH (Follicle Stimulating Hormone) is the primary hormone used to stimulate the ovaries to produce
several eggs for IVF. Several medications contain FSH, i.e., Follistim, Gonal-F, Bravelle, Menopur,
Repronex, etc.
Administration
FSH is not active orally and requires a series of injections. You and/or your husband will be given
instructions on how to mix and administer the injections. On the days you are instructed to take FSH, the
injections should be given about 12 hours apart.
Monitoring
FSH is a very potent stimulator of the ovary and requires close monitoring to insure not only adequate
egg development, but also its safe use. Monitoring will include blood tests for estradiol and vaginal
ultrasounds to visualize follicle development. These will usually begin on the fifth day of FSH use.
Schedule
This schedule must be closely followed (also refer to the IVF calendar):
1.
Call our office (321-4740) on the first weekday after your period starts. You and your husband
will begin Doxycycline or Zithromax (Z-pak) by cycle day 8. You will begin oral contraceptive pills
on cycle day 3. You will begin daily Lupron injections approximately cycle day 17, as instructed.
You will also be scheduled for your first monitoring day, between cycle day 27 and cycle day 35.
2.
On the first monitoring day, you will arrive at our office at your scheduled appointment time. You
may eat normally and do not need a full bladder when you arrive.
3.
You will need to call our office between 3:00 and 4:00 p.m. on the day you are monitored to find
out when to start FSH and the dose to take. Your doctor/nurse will instruct you when to begin
these FSH injections when your estradiol level is adequately suppressed. You will also be
scheduled for your next day of monitoring.
4.
Monitoring (estradiol and ultrasound) for follicular growth will usually begin five days after the FSH
injections are started. You will arrive at our office at the appointed time. Again, you may eat
normally and you do not need a full bladder before you arrive.
5.
When monitoring reveals that sufficient follicular growth has been achieved, your doctor/nurse will
instruct you to inject hCG (human chorionic gonadotropin), which causes the follicles to prepare
for ovulation. Inject at the exact time instructed since your egg retrieval is scheduled according to
the time of hCG injection.
Risks
FSH, like most medications, is not without some risks. The following discusses some, but not all of the
risks.
Most patients given FSH develop some ovarian stimulation. In rare cases, the stimulation can be
abnormally marked or severe. This stimulation, known as hyperstimulation, occurs in only 1-2% of
stimulations and tends to occur more often in stimulations which result in pregnancy. Hyperstimulation
may require hospitalization and can be life threatening if not treated. Symptoms of hyperstimulation are
excessive low back or ovarian pain, nausea and vomiting, weight gain, bloating, abdominal distention,
and infrequent urination. These symptoms will most likely occur one to two weeks after hCG. If you
suspect hyperstimulation, contact your doctor.
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In addition, since your Estradiol (estrogen) level will be increased by the ovarian hyperstimulation, you are
at increased risk for developing a blood clot. This can be a very dangerous situation that can result in a
pulmonary embolus (blood clot to the lung), heart attack, or stroke. This could result in additional
hospitalization and medical treatment.
LONG TERM RISKS OF FERTILITY DRUGS
Several publications have suggested that there may be long term risks associated with the use of fertility
drugs. In particular, early studies suggest that women who take fertility drugs may have an increased risk
of developing ovarian cancer. While more recent studies have cast doubt on these claims, you still need
to be aware of this concern. The magnitude of this risk and the identification of which patients may be at
risk are still under study. More basic and epidemiologic research is needed to define whether this is a
true association, which drugs are implicated, and which patients may be at risk.
There are risks associated with any treatment for infertility, and these risks must be weighed against the
benefit expected from that treatment. Please ask us any questions you may have regarding this.
Miscellaneous
Since each woman responds differently to medications, it is impossible to correctly predict how much FSH
you will require, even after the stimulation is underway. You are urged to keep two days supply on hand
so that at 5 p.m. you do not begin a frantic search for more. Many local pharmacies can order FSH, but
they need advance warning and usually require 48 hours to fill an order. In preparation for weekends, be
certain you have a sufficient supply to last until the next weekday. If any questions arise during your
stimulation, do not hesitate to contact our office at (615) 321-4740.
I have read the above and have had my questions answered. I agree to the administration of drugs for
stimulating ovulation.
This agreement will be governed by and construed in accordance with the laws of the state of Tennessee,
which is the place of operation of Nashville Fertility Center, P.C. (NFC).
____________________________________________________
Egg Donor’s Signature
__________________
Date
____________________________________________________
Physician’s Signature
__________________
Date
__________________________________________________
Witness
__________________
Date
2009
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