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FDA Requirements for Third Party

Third-Party reproduction at FCI using a known Oocyte donor, anonymous oocyte donor, or known directed Semen donor requires a thorough pre-screening of any oocyte or semen 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 the recruiting agency and in the case of a known egg donor or semen donor FCI can provide you with the names of several psychologists who offer this service.
  2. Screening/ lab testing — in the case of an anonymous egg donor, this is arranged for by the recruiting agency and in the case of a known egg or semen donor, FCI will provide this service.
  3. A physician consult and physical examination and risk assessment are done at FCI for any egg donor. A known directed semen donor needs a physical examination performed by his primary care physician. The known directed semen donor will need to complete a risk assessment evaluation with FCI as well.

Once this screening process is complete, the FCI physician will give his/her approval of the egg donor and/ or known directed semen 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:

  • Gonorrhea and Chlamydia vaginal or urine cultures
  • HIV-I and HIV-II screening
  • Hepatitis B surface antigen and Hepatitis B core antibody
  • Hepatitis C antibody
  • RPR
  • Medical History/ physical exam/ and risk factor assessment

The cost of this FDA required package of tests is $350.00 and is not included in the regular IVF and/ or egg donor/ surrogacy package: FCI will bill the recipient’s insurance company if the insurance company provides this benefit or the recipient will be billed if there is no insurance benefit.

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.

Any 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. Transfer of these embryos to an offsite facility is responsibility of the recipient couple.

Please be aware, that FCI sends the required FDA lab work/ vaginal cultures to an outside facility. Ordinarily results should be reported within four days of testing; however, once the tests leave our office, we depend on the outside laboratory to provide results in a timely fashion.

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, we believe that this policy will improve the quality of care provided to our patients.

If you have any questions regarding the FDA regulations, please contact your FCI physician 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.

Thank you again for your understanding. FCI will try to do everything we can to make the implementation of this policy a smooth process for you as well as result in a healthy and positive outcome.