By: Marna Gatlin

This article is not to be used in a replacement for medical advice, instruction, or medical education to any intended or recipient parent interested in receiving donated eggs to create their family or to any egg donor who is interested in donating eggs to a bank, clinic, agency, or intended or recipient parent.

PVED’s intent for this article is to educate intended parents and egg donors about some of the medical issues that may disqualify them for egg donation either temporarily or permanently.

Since May 25th, 2005 The FDA has issues regulations modifying donor eligibility regarding good tissues practices. These regulation remedy the concerns we had about the timing requirements for infectious disease testing for egg donors and the testing requirements for couples who complete their families and then decide to donate their remaining embryos to another infertile couple.

These FDA guidelines that are to be used by all infertility clinics and IVF centers when deciding or determining the eligibility of an egg donor who is interested in donating her eggs. The FDA has created these guidelines as a way of appropriately reduce the risk of transmission of relevant communicable diseases.

The FDA concerns are due to the "high risk" behaviors of those egg donors who want to donate human tissue (namely their eggs) because there have been those individuals who have developed severe medical complications or have died after receiving donated tissue other than eggs from an egg donor. Because of this these guidelines have been created to protect those who would be recipients of the tissue, the FDA has developed a list of “high risk” behaviors as well as mandated tests for screening the potential donors before the tissue will be accepted and allowed for use by the tissue procurement center.

Below is information that you may want to know before becoming a recipient of donated embryos.

Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps). Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA and list their HCT/Ps in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271¹.

You can access information on registered HCT/P establishments by visiting their website. The site includes the names of registered establishments, the products that they manufacture, and the manufacturing steps they perform.

Are reproductive HCT/P donors required to be screened for risk factors that may increase the chances of transmitting a communicable disease?

Yes. Donor screening consists of reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. These records include a current donor medical history interview to determine medical history and relevant social behavior, a current physical examination, and treatments related to medical conditions that may suggest the donor is at increased risk for a relevant communicable disease.

Are reproductive HCT/P donors required to be tested for infectious diseases?

This following list of required tests was last updated by FDA in February 2008, so in the future the FDA may eliminate tests, add additional tests or change the method for specific tests in the future as there are advances made in technology and knowledge. Each tissue procurement facility (IVF center) may add to the list of tests required by FDA, but all facilities are required to test for the following unless they meet specific exemptions as allowed by FDA. Specimens from reproductive tissue donors must be tested for the following infectious diseases (referred to as “relevant communicable disease agents and diseases” in the regulations):

1. Human Immunodeficiency Virus (HIV), types 1 and 2
2. Hepatitis B Virus (HBV)
3. Hepatitis C Virus (HCV)
4. Treponema pallidum (i.e. syphilis)
5. Chlamydia trachomatis
6. Neisseria gonorrhea

In addition to those listed above, sperm donors must also be tested for:

1. Human T-lymphotropic virus (HTLV), types I and II
2. Cytomegalovirus (CMV)

Are reproductive HCT/P establishments inspected by FDA?

Yes. Various factors can determine the frequency of inspection, including any objectionable conditions found on a prior inspection and/or if FDA received Information regarding an establishment indicating there is a potential violation of FDA regulations.

Where can I get more information?

Related information about the regulation HCT/Ps can be found on FDA’s website at:
http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/default.htm4.

Your head might be swimming about now with all of this clinical information but keep in mind that a positive result for some of the required tests may only disqualify you for a specific period of time. However, a positive result for other tests will permanently disqualify a person.

And here is where sometimes we can find a work around to some of these tests. There are some exceptions made if the egg donor is “a known donor” to the intended parent / recipient who will be carrying the pregnancy. The exact qualifications to be classified as a “known donor” (and therefore exempt from disqualification based on positive test results) is different for each IVF center. Typically a known donor of any kind is an intimate sexual partner, a family member, or a person known to the recipient for a very long time – like a good friend etc… However, regarding egg donation a known donor can also be a woman who has agreed to meet the intended parents, share her contact information, name so they might have an ongoing relationship. Egg donors and intended parents alike need to remember that just because the egg donor may test positive under any of the categories listed that would typically disqualify as an anonymous donor it doesn’t mean you can’t donate. It all depends the category you were disqualified under and what those requirements are regarding anonymous or known egg donation. You need to check with your IVF Center for medical information regarding these tests.

The FDA is not just concerned with high risk sexual behaviors (though in egg donation that is the main reason for disqualification from donating eggs.) The FDA is also apprehensive with a person’s drug usage, time spent in prison, and diseases that may be contracted during the donor’s travel outside of the U.S. Some areas of the world are on what they refer to as a “hot list” of places that have a high risk of exposure to such things as SARS, HIV, West Nile Virus, Malaria and Mad Cow Disease, Swine Flu as well as other communicable diseases.

Some of these diseases which are transmissible may only require postponement of the donor for a specific time period after potential exposure or treatment of infection. The symptoms of Mad Cow Disease may take several years to appear and exposure during the specified times listed my mean permanent deferment of the donor. The rule of thumb is that if a person has been rejected as a blood donor they will most likely be rejected as an egg donor or as any other type of donor of human tissue.

Please see the following list of Blood Bank criteria for donors, which will include countries that are considered “hot spots” and dates for travel or residency that most blood banks use when determining the eligibility of a blood donor.

For more information you can go to www.ASRM.org and look up Summary of Eligibility Determination for Donors of Human Cells, Tissues, And Cellular And Tissue-Based products found here:

http://www.reproductivefacts.org/news/article.aspx?id=337

If you have any other questions regarding this topic please consult your IVF Center.