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Human Embryo Cryopreservation part 2                      Send Link

 Informed Consent

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.

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Patient Date
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Partner (if applicable) Date
_________________________________________________________
Notary Public/Witness Date

 

CRYOPRESERVATION OF FERTILIZED EGGS AND/OR EMBRYOS
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").