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Learn The FDA Requirements for Egg Donation

Posted on October 21, 2013

Learn The FDA Requirements for Egg Donation

Third-Party reproduction using a known Oocyte donor, anonymous oocyte donor requires a thorough pre-screening of any oocyte donor prior to IVF. There are three important steps required prior to approval:

  1. A psychological examination – in the case of an anonymous egg donor this is arranged for by Creative Love Egg Donor Agency, LLC. In the case of a known egg donor (ie, friend)  Creative Love Egg Donor Agency  can provide you with the names of several psychologists who offer this service.
  2. Screening/ lab testing – All medical screening and labs are completed at your selected fertility clinic or a remote center.
  3. A physician consult and physical examination and risk assessment are done at your fertility clinic for any egg donor.

Once this screening process is complete, your fertility doctor will give his/her approval of the egg donor.

Recently, The US Food and Drug Administration (FDA) implemented new mandatory regulations guiding third-party reproduction. The new FDA regulations took effect May 25th, 2005. The immediate implication of these regulations is that all egg donors (oocyte source) will require (re) testing no more than 30 days prior to Egg Retrieval. The following are FDA required tests prior to egg retrieval in donor or Surrogate cases:

  1. Gonorrhea and Chlamydia vaginal or urine cultures
  2. HIV-I and HIV-II screening
  3. Hepatitis B surface antigen and Hepatitis B core antibody
  4. Hepatitis C antibody
  5. RPR
  6. Medical History/ physical exam/ and risk factor assessment

The cost of this FDA required package is typically included in your IVF/Egg Donor Cycle at your clinic.

A known sperm donor must undergo the same testing, substituting a urine culture for the Gonorrhea and Chlamydia cervical cultures and in addition CMV total and HTLV 1&2 screening within seven (7) days of intended use or freezing for later use.

Results of these FDA required tests must be available prior to recipient’s Embryo transfer. If any of the egg donor’s (oocyte source) FDA tests are abnormal, cancellation of the egg donor’s/ intended parent’s Cycle-prior to retrieval-will occur. In the unlikely event that any of the egg donor or known directed sperm donor’s FDA tests are unavailable at the time of egg retrieval, the egg retrieval can still be performed as scheduled, and the following situations may result:

  • Proceed with scheduled embryo transfer: Results are received after retrieval, but before scheduled transfer and all of the tests are normal.
  • Freeze all embryos: If the FDA donor tests are not available on the day of scheduled embryo transfer, all embryos must be frozen and quarantined at an offsite facility.
  • Cancellation of future recipient embryo transfer (after freeze all), if any of the FDA donor tests result abnormal.

Normally if there are abnormalities (FDA required tests) of an anonymous or known egg donor or known directed semen donor need to be followed up with the donor’s physician. Also, if any known donor test results are detected positive and the couple and known donor decide to proceed with the Egg Donation process, but freeze all embryos, that may require an additional storage fee for the transfer mechanism and quarantine of embryos at an offsite facility.

The FDA regulations were instituted in an effort to keep donor egg and donor sperm recipients safe from infection. Although third-party reproduction testing is more complicated than in prior years, it is believed that these polices will improve the quality of care provided to all patients. If you have any questions regarding the FDA regulations, please contact your fertility clinic immediately to discuss any issues, as it may impact your ability to proceed with anonymous donor egg, known donor egg or directed semen IVF treatment.

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