What is the FDA requirement for egg donors?

The process of surrogacy is in demand these days for childless couples. There are two kinds of surrogacy - gestational surrogacy and traditional surrogacy.

In gestational surrogacy, you need an egg donor and a sperm donor. The egg donor can be the intended mother of the child or any other woman and the sperm donor can be the intended father of the child or any other male. But can we take the egg from egg donor so easily? No, there are FDA guidelines that you need to follow by IVF Clinic while carrying out an egg donation process.

Fertility clinics can use egg donation services for IVF only or IVF surrogacy process.

The third-party oocytes donor requires to go under approval which involves three steps to follow. These steps are -

1. In the case of an anonymous donor of eggs, this is arranged by the recruiting agency.
2. Laboratory screening — In the case of an anonymous egg donor, this is done by the recruiting agency and the recruiting agency will provide this service in the case of a confirmed egg or semen donor.
3. For any egg donor, a medical consultation and physical examination and risk assessment are performed at the recruiting agency. A confirmed direct donor of semen requires a physical exam performed by his primary care doctor. The identified direct donor of semen will also need to complete an analysis of the risk with a recruiting agency.

Once the screening process is completed successfully, the doctor will give you his/her consent regarding the same.

The US Food and Drug Administration (FDA) has recently implemented new mandatory guidelines to direct the reproduction of third parties. The immediate consequence of these regulations is that no more than 30 days before Egg Retrieval, all egg donors (oocyte source) would need (re) screening. The following are FDA tests required in donor or surrogate cases prior to recovery of eggs:

• HIV I and HIV II testing
• Testing for Chlamydia vaginal or urine cultures and Gonorrhea
• RPR
• Hepatitis C antibody
• Hepatitis B core antibody and Hepatitis B surface antigens
• Physical exam, Medical history, and Risk Factor assessment.

The price of this test kit needed by the FDA is $350.00 and may or may not be included in the standard IVF and/or egg donor/surrogacy plan: The recruiting agency must pay the insurance company of the recipient of the insurance company offers this benefit or the recipient is charged if there is no insurance benefit. A confirmed donor of sperm should undergo the same examination, replacing a sample of urine for the cervical cultures of Gonorrhea and Chlamydia, as well as CMV complete and HTLV 1&2 screening within seven days of planned use or freezing for future use.

The results of these tests needed by the FDA must be available before the transfer of the embryo from the recipient. If any of the FDA checks of the egg donor are irregular, the Cycle-prior to the retrieval of the egg donor / intended parent will be canceled. In the unlikely event that any of the FDA tests of the egg donor or known direct sperm donor is unavailable at the time of egg collection, the egg collection can still be conducted as planned and the following situations the result -

1. Proceed with the scheduled transfer of the embryo: results are obtained after healing, but all tests are routine before the scheduled transfer.
2. Freeze all embryos: all embryos must be frozen and quarantined at an offsite facility if the FDA donor samples are not available on the day of scheduled embryo transfer.
3. Cancelation (after freezing all) of potential recipient embryo transfer if any of the FDA donor tests were abnormal.

Any unknown or identified egg donor defects (FDA approved tests) or known targeted semen donor must be followed up with the donor's doctor. However, if any known donor test results are found to be positive and the couple and known donor agree to continue with the Egg Donation procedure or freeze all embryos that may entail an additional storage charge for the transfer system and embryo quarantine in an offsite facility. The recipient couple is responsible for moving these embryos to an offsite plant.

In an effort to keep donor eggs and donor sperm recipients free from contamination, FDA guidelines are introduced. While the evaluation of replication by third parties is more difficult than in previous years, we agree that this approach would improve the quality of care given to our patients. If you have any concerns about the FDA regulations, please contact your recruiting agency's doctor to address any issues immediately, as this may affect your ability to continue with anonymous donor egg, registered donor egg, or IVF semen therapy.

IVF Conceptions offer legally secure and affordable surrogacy consulting services for FREE. Get in touch to start your family.

I am Neelam Chhagani and work as infertility and surrogacy consultant since 2010. I have a blog— , providing information, guide, and support to the would-be parent.