General Information on Embryo Donation/Adoption
- How is embryo donation different from embryo adoption?
Human embryos have been donated by families to fertility clinics for many years. Perhaps the legal ownership of the embryos was transferred between the donor and the clinic, perhaps not. In any event, the clinic staff became responsible for using these donated embryos to help other couples and singles achieve pregnancy or donate to scientific research. The achievement of successful pregnancy remains the primary goal of most fertility clinics today.
Fertility clinics strive to provide their patients with excellent medical care. The social and emotional aspects surrounding the donation of embryos is generally not a priority. Donation programs within the clinic environment are mostly limited to the current patient population. There are a handful of clinics who make their embryo donation programs open to all.
The medical staff of the clinic will normally choose which patients will receive particular donated embryos. It is not uncommon to have embryos donated by one family, and therefore genetically the same, divided between multiple recipients. The donor most likely will not know or be known by the recipient(s). Counseling for either the donor or recipient supplied by the clinic is rare.
Adoption programs regard embryo donation as equivalent to a traditional adoption process since the hoped for outcome is the birth of a child, a child who is not related genetically to the recipient family. They will offer similar assistance and services as with a domestic adoption. The social and emotional aspects of this unique family building option are the agency's focus. Education of the donor and adopting family is child-centric with the end goal to help both families and the resulting children understand and manage these non-medical aspects of the process.
- What possible benefit could there be for our clinic to become involved with an adoption agency?
When a clinic chooses to partner with an adoption agency the benefits positively impact both the clinic's patients and the clinic business. This partnership can move future liability regarding embryo placement issues from the clinic to the agency. The agency maintains the social, emotional and legal education and documentation of embryo adoption.
- Offers direct assistance from the agency to patients for embryo disposition decisions
- Agency manages the program, not the clinic, unbiased matching completed by agency
- Future communication between parties is the agency's responsibility not the clinic's
- Reduces clinic paperwork and future liabilities
- Clinic controls embryo/birth statistics by keeping embryos in-house
- New patients are directed to the clinic bringing new revenue
- Uses embryos created, frozen and thawed by the clinic
- Reduces embryo storage at the clinic
- Reduced/eliminated transportation of embryos between clinics
- What are the most significant legal issues associated with embryo adoption?
The most significant legal issue associated with embryo donation and adoption relates to the unsettled nature of embryo adoption law and the contractual agreements used to legally bind donor and recipient couples.
First, both the donor and recipient couples should acknowledge that the law of embryo donation and adoption is unsettled. There are no federal or state laws specifically governing the adoption of embryos although some states do have laws generally related to embryo donation and/or assisted reproductive technology.
Second, the embryo donation and adoption process involves adoption agreement and relinquishment forms, which are legal contracts between the donor and recipient couples. These forms formalize the genetic parental relinquishment of their parental rights prior to the embryo being transferred to the receiving mother. Once transferred, the embryos belong to the adopting parents. Parties involved should also note that embryos have a special legal status that is yet to be clearly defined. While many courts are reluctant to classify embryos as property, they also do not characterize them as human beings. As a result, embryo adoption programs may differ in how they define embryos in their legal agreements. Some may refer to embryo donation as a transfer of property while others may incorporate traditional adoption language into their legal documents.
- What are the benefits of embryo adoption to the donating family?
It relieves the couple of the psychological burden of having frozen embryos that they in storage.
They are honoring their own children who were born through the IVF process by allowing embryo siblings a chance at life.
They experience the satisfaction of providing another infertile couple the chance to build their family.
There is greater assurance that the adopting family has been well screened and evaluated for their ability to become successful in raising adopted children.
- What are the costs to the donating parents?
There are no fees for the donating parents to participate in the program. There may be costs during the process if any additional blood work is required per FDA guidelines, depending on where the embryos are going and what types of tests the donating family has had, but the adopting family most likely will be asked to cover these costs.
- Does the adopting family help with any of the fees owed by the donating parents?
Typically, adopting families do not pick up any of the expenses associated with the donor family's fertility treatment. Adopting families do often reimburse donating families for any expenses incurred during or after they are matched. This includes shipping fees, legal costs and any fees associated with medical or psychological screening. These may be included in the overall program fee if done through an experienced agency. Any sort of direct compensation for the embryos themselves is under the legal jurisdiction of each state, and interested parties should seeks legal advice to determine the applicable laws in their states. In general, such payments are not recommended by the American Society of Reproductive Medicine (ASRM) or the American Medical Association(AMA)on ethical grounds.
Once donating and adopting families have selected one another, the embryos are shipped to the adopting family's clinic, where the adopting family then becomes responsible for storage costs incurred. Depending on how many embryos a donating family has, if an adopting family completes their family with embryos still remaining, there may be a chance that those remaining embryos would once again become the donating family's responsibility for storage fees and selection of another family.
Medical Information and Requirements
- What type of patient medical information will our clinic receive about the donating parents and their embryos?
Your clinic will receive:
- Infectious disease screening results (an FDA requirement)
- embryology reports
- embryo freezing and thawing protocols
It is likely that the program your patients are working with will be able to contact the donating parents and their clinic to obtain additional information as necessary.
- What are the current FDA requirements for blood tests?
The U.S. Food and Drug Administration (FDA) has published regulations regarding human tissue donation that effects embryo donation and adoption. On May 25, 2004, the FDA published final rules addressing donor testing/ screening and good tissue practice. The FDA subsequently issued an interim final rule on May 25, 2005, which amended certain sections of those regulations. For additional information on the rule, see the FDA's web site Question and Answer section at:
Previously, the FDA rules exempted sexually intimate partners engaged in reproductive treatment, from infectious disease testing prior to the creation of their embryos, which were intended for the couple's own use. The interim final rule expanded this exemption, which now permits couples who were not originally screened for infectious disease to donate their cryopreserved embryos to other couples. The regulations do suggest that attempts to test these donor couples should be made before the embryos are transferred to the recipient, but, when testing is not possible, the recipient should at least be advised of the potential communicable disease risk. Given that FDA regulations may change, you should be sure to understand what screening and testing requirements are in effect at the time of your donation.
When issuing the interim final rule, the FDA stated, "We are now adding a new exemption from screening and testing in Sec. 1271.90(a)(4) for cryo preserved embryos that, while originally exempt from the donor eligibility requirement because the donors were sexually intimate partners, are later intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and acolyte donors before transfer of the embryo to a recipient. This change reflects the fact that sexually intimate partners may decide to donate their cryopreserved embryos long after their fertility treatments are completed. Because the embryos were intended for use in a sexually intimate relationship the donors would not have been required to be screened and tested for communicable disease agents at the time that oocytes and semen were recovered. The new provision recommends that appropriate measures be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient, when possible.
The current FDA mandated blood tests include:
- HIV 1 and 2
- HTLV I/II
- Hepatitis B surface antigen
- Hepatitis B Core Antibody (IgG/IgM)
- Hepatitis C Antibody
- RPR (Syphilis)
- CMV IgG/IgM
- Gonorrhea/Chlamydia culture
- Blood Typing
- Rh factor
- What counseling should be offered to the donating and adopting families?
Counseling is an important component of the services that should be offered in an embryo adoption and, in fact, is specifically included in the ASRM's guidelines for donating embryos. Drawing upon the traditional model of adoption, the type of counseling services made available and offered in an embryo adoption situation should be similar. For example, local area donating families should be provided with counseling services at no charge. Counseling for local adopting families should be included in their program fees.
Storage and Transportation of Embryos
- Where are the embryos stored while the genetic/donor family is finding an adoptive couple? Who pays for that storage?
The embryos remain stored at the original IVF clinic or at a long term storage facility designated by the genetic/donor family during the adoption process. The genetic family pays for storage during this time.
- Who handles the coordination of the embryos' travel from one clinic to another?
It is usually the responsibility of the patient's private embryo adoption provider, agency or attorney to coordinate the embryo's travel between the placing and adopting clinics.
- What if the clinic does not have a dry shipper?
The agency or attorney with whom your patients are working should be able to coordinate the rental of an appropriate shipping container for you.
- What are best practices regarding embryo storage?
Some clinics have time limits regarding storage of your embryos at their facility. After that time limit has expired they may require patients to move their embryos to an off-site facility (a cryo-bank) or give them the option to have the embryos discarded.
If your clinic already does, or is considering moving your frozen embryos to a cryo-bank, it is critical for you to understand the rules governing the storage of these embryos from your patient's perspective. How easy will it be for your patient to access their embryos from the cryo-bank? Will it be a financial burden to them to remove them from the cryo-bank should they choose to donate their embryos in the future?
In an effort to more stringently follow FDA rules for embryo donation and storage, some cryo-banks have created fee schedules to cover their expenses and these fees can make it difficult for the family who wishes to donate their embryos to another couple to get them released from storage.
Be sure to read the fine print and understand the requirements and costs of storage and removal from storage at any cryo-bank facility.
Embryo Recipient Guidelines
- Is there a limit on the length of time our recipient patients have to use their adopted embryos?
Time limits are usually incorporated into the legal contract language for the transfer of embryos from one party to another.
- If there are still adopted embryos remaining after our recipient patients are done, what do we do?
In an embryo adoption program it is customary for the adopting family to return any embryos they do not plan to use for their own family building to the original donating family. The original family can they determine and choose a second adopting family for their embryos.
This issue is usually detailed in the contracts signed by both parties to eliminate future surprises.
"We are very impressed with the FDA information distributed through the webinars.
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It also sparks discussions among our group specific to our center."
Stacy M. Carney, Embryologist, Reproductive Associates of Delaware