I/We, _____________(woman, referred to herein as "Patient") and _____________(referred
to herein as Spouse/Partner), have elected to use embryo cryopreservation
(freezing) as a component of our in vitro fertilization (IVF) therapy at
Georgia Reproductive Specialists (referred to herein as "GRS").
BACKGROUND
In the course of an IVF treatment cycle, more viable embryos may be produced
than are desired for embryo transfer in that same cycle. If so, these "excess"
embryos can be preserved by freezing and stored for future use. In addition,
there are conditions under which the physician managing your treatment
will recommend that all embryos be frozen and that no embryo replacement
be performed during your IVF treatment cycle. One such reason for this
recommendation would be if the patient were at high risk for hyperstimulation
syndrome at the time of your oocyte retrieval. Hyperstimulation syndrome
is exacerbated by pregnancy and is easier to manage if the patient is not
pregnant. In this situation, all viable embryos will be frozen and the
replacement of thawed embryos will be performed only after the patient
has recovered from the hyperstimulation.
Embryos may be frozen immediately after fertilization at the pronuclear
stage, during early cleavage (2 to 8 cell stage) and after 5 to 7 days
of culture at the blastocyst stage. If the patient and spouse consent to
cryopreservation, the stage at which any embryos are frozen will be determined
by laboratory personnel in conjunction with the physician managing your
treatment.
The embryos will be stored in the frozen condition until the patient
and spouse request their use and the physician responsible for your care
determines that appropriate conditions exist in the patient for transfer
of the embryos into the patient's uterus. At that time, some or all of
the embryos will be thawed. Each embryo will be examined to determine whether
it is potentially viable, and if so, the transfer into the patient's uterus
will occur.
The pregnancy success rate with frozen embryos transferred into the
human uterus is approximately the same as with non-frozen embryos. However,
some embryos do not survive the freezing process. Potential benefits of
embryo freezing are an increased opportunity of achieving a pregnancy without
undergoing multiple egg retrievals, a reduced risk of a multiple pregnancy
(twins or more) by reducing the number of embryos transferred during the
IVF treatment cycle, and better management of complications associated
with the IVF treatment cycle such as hyperstimulation as described above.
RISKS AND LIMITATIONS
- Establishing an IVF pregnancy using frozen thawed embryos cannot be
guaranteed for any woman.
- Some or all embryos may not survive freezing and thawing.
- Additional expenses are associated with the use of embryo freezing.
- Embryo freezing has been successfully used in animals with no known
adverse results. There is, however, relatively limited experience with
human embryos. Although no increased rate of birth defects have been reported
from the relatively limited number of births from frozen human embryos,
the risks associated with human embryo freezing, thawing and transfer
are not well established at present.
- Failure of storage containers can result in the loss of liquid nitrogen
and damage or kill all of the embryos. Embryos are stored in industry
standard cryo storage tanks, that are monitored regularly for liquid nitrogen
level and maintained at greater than 75% of their capacity. Also the tanks
are monitored by an alarm system that will signal laboratory personnel
should liquid nitrogen levels become dangerously low. Even so, there is
the potential that a tank might fail due to a spontaneous loss of vacuum
or rupture of the vessel. Also disasters such as fires and storms as well
criminal acts could damage the building housing the tanks and/or the tanks
themselves. Any such event could result in the loss of the specimens.
- You must agree to and accept future disposal of any remaining unused frozen embryos.
You must determine prior to your IVF cycle whether you will in the future consider donating your
remaining frozen embryos to a known couple or to GRS to offer to another couple for anonymous adoption
or if you think there may be a need for a gestational carrier in the future in order to begin testing
required by the FDA. I/We have been counseled by my/our physician on the FDA regulations and have had
the opportunity to have all questions answered.
_____ ______ I/We DO want to begin the process of screening per
the FDA regulations keeping our options open for the future in case a need
arises for a gestational carrier and/or I/We elect to donate our embryos
to a known or anonymous couple. We are aware that choosing this option
will require additional laboratory testing of patient and partner (or sperm/egg
donors) to be done within 7 days of oocyte retrieval and sperm collection.
An additional physical exam for screening prior to IVF starting and another
exam 6 months after the IVF cycle will be required on the partner (sperm
donor). Additional paperwork must be completed as well for both patient
and partner prior to IVF initiation. This testing will result in additional
administrative costs, laboratory fees, and medical expenses not covered
by the IVF fee and may not be covered by insurance. If not obtained, we
understand that the FDA mandates that the embryos are not suitable for
transfer to a gestational carrier or anonymous adopting couple.
_____ ______ I/We DO NOT want to begin the process of screening
per the FDA regulations and understand that by declining this additional
testing our embryos will not be eligible for use with a gestational carrier
in the future and/or will not be eligible for adoption by a known or anonymous
couple.
Several options for disposal of unused frozen embryos are described
below.
DISPOSAL OF EXCESS FROZEN EMBRYOS
I/We agree to immediately update GRS should our address change and agree
that our failure to maintain a current address with GRS will signify our
desire to terminate storage of frozen embryo(s).
I/We agree to utilize, dispose of, or make other arrangements for storage
of our cryopreserved embryo(s) within a period of five years following
their initial cryopreservation.
Should the yearly fee for storage of our frozen embryo(s) remain unpaid
for a period of one year after the first invoice is forwarded to our address
as it is listed in our clinical records at GRS, GRS can conclude that we
are no longer interested in storing these specimen(s) and GRS may dispose
of all of our frozen embryo(s) in the manner I/we have indicated below.
In addition, GRS will dispose of the frozen embryo(s) in the manner we
have indicated below, if I/we provide written notification of our desire
for the embryo(s) to be discarded.
In the event that either of the above mentioned situations occur, I/we
hereby instruct and authorize GRS to dispose of any frozen embryo(s) as
follows (Patient and Spouse must both initial the same choice):
_____ ______ Thaw and dispose of the frozen embryo(s) in a manner deemed
appropriate by GRS.
_____ ______ Donate the frozen embryos to GRS to offer the embryos for
anonymous adoption by another couple. It is understood that if we select this option
we waive any right and relinquish any claim to the donated embryos or any pregnancy
or offspring that might result from them. I/We agree that any recipient receiving
embryos which I/we have donated to GRS may regard the donated embryos and any
offspring resulting from as her/their own children. If no adoptive couple is found,
GRS, at its discretion, is authorized to thaw and dispose of the embryos in any
manner deemed appropriate by GRS. If this option is chosen additional laboratory
testing of patient and partner (or sperm/egg donors) will be required within 7 days
of oocyte retrieval and sperm collection. An additional physical exam for screening
prior to IVF starting and another exam 6 months after the IVF cycle will be required
on the partner (sperm donor). Additional paperwork must be completed as well for
both patient and partner prior to IVF initiation. This testing will result in additional
administrative costs, laboratory fees, and medical expenses not covered by the IVF fee
and may not be covered by insurance. If not obtained, FDA mandates that embryos are not
suitable for transfer. I/we understand that if we have not completed the required 6
month follow up testing by the time that the decision is made for the embryos to be
donated to GRS, that GRS will dispose of or donate my/our embryos to research as deemed
appropriate by GRS staff.
_____ ______ Donate the embryos to GRS for use in research projects permitted
under the policies of Georgia Reproductive Specialists' policies and applicable legal
requirements.
In the case of one of the circumstances listed below, I/we instruct
GRS to conduct disposition of any and all remaining frozen embryos based
on our current wishes. Our wishes regarding each of the following situations
are indicated by our initials. (Patient and Spouse/Partner must both initial
the same choice):
Patient's Death
_____ ______ Disposition of embryos to be determined by Partner.
_____ ______ Disposal of the embryos in any manner deemed appropriate by
GRS.
Spouse's Death
_____ ______ Disposition of embryos to be determined by Patient.
_____ ______ Disposal of the embryos in any manner deemed appropriate by
GRS.
Death of Couple
_____ ______ Disposition of embryos to be determined by my estate. If this option is
chosen additional laboratory testing of patient and partner (or sperm/egg donors) will be
required within 7 days of oocyte retrieval and sperm collection. An additional physical
exam for screening prior to IVF starting and another exam 6 months after the IVF cycle
will be required on the partner (sperm donor). Additional paperwork must be completed as
well for both patient and partner prior to IVF initiation. This testing will result in
additional administrative costs, laboratory fees, and medical expenses not covered by the IVF
fee and may not be covered by insurance. If not obtained, FDA mandates that embryos are not
suitable for transfer.
_____ ______ Disposal of the embryos in any manner deemed appropriate by GRS.
_____ ______ Donation to GRS to offer the embryos for anonymous adoption by another
couple. If this option is chosen additional laboratory testing of patient and partner
(or sperm/egg donors) will be required within 7 days of oocyte retrieval and sperm collection.
An additional physical exam for screening prior to IVF starting and another exam 6 months
after the IVF cycle will be required on the partner (sperm donor). Additional paperwork
must be completed as well for both patient and partner prior to IVF initiation. This testing
will result in additional administrative costs, laboratory fees, and medical expenses not
covered by the IVF fee and may not be covered by insurance. If not obtained, FDA mandates
that embryos are not suitable for transfer.
Divorce (if not addressed in the divorce settlement)
_____ ______ Disposition of embryos to be determined by Patient.
_____ ______ Disposition of embryos to be determined by Spouse.
_____ ______ Disposal of the embryos in a manner deemed appropriate by
GRS.
COMPREHENSION OF CONSENT AGREEMENT
I/We have read and understand this document and additional information
provided to us. I/We have discussed this document and additional information
with a GRS physician, who has provided us ample opportunity to ask any
questions regarding IVF therapy and cryopreservation and who has answered
these questions to our satisfaction. I/We acknowledge that no guarantee
or assurance has been made as to the results that may be obtained. I/We
further acknowledge that this document is by no means a complete record
of our conversations with Georgia Reproductive Specialists physicians,
and staff and are satisfied that I/we are sufficiently advised and informed
to make this decision.
CONSENT
I/We, understand and accept the conditions, risks and limitations of embryo
cryopreservation. I/We therefore voluntarily consent to the use of embryo
cryopreservation to preserve the excess embryos resulting from our IVF
therapy for potential future use. I/We are of eighteen (18) years of age
or older.
RELEASE
I/We agree to absolve, release, indemnify, protect and hold harmless Georgia
Reproductive Specialists, it's officers, directors, agents and employees,
from any and all liability for any adverse outcome, however remote, resulting
from the cryopreservation and storage of our fertilized eggs and/or embryos,
including but not limited to the loss or destruction of our fertilized
eggs and/or embryos, and/or the birth of a physically or mentally deficient
child. Additionally, I/we release, discharge and hold harmless Georgia
Reproductive Specialists, it's officers, directors, agents and employees
from any and all liability in connection with any subsequent disputes between
patient and spouse regarding the control of any frozen fertilized eggs
or embryos, or the custody and/or support of any children ultimately born
as a result of this procedure.
_________________________________________________________
_________________________________________________________
| Partner (if applicable) |
Date |
_________________________________________________________
| Notary Public/Witness |
Date |
