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.

• 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.

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 & 2

HTLV I/II

Hepatitis B Surface Antigen

Hepatitis B Core Antibody (IgG/IgM)

Hepatitis C Antibody

RPR (Syphillis)

CMV IgG/IgM

Gonorrhea/Chlamydia Culture

Blood Typing

Rh Factor

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.