The criteria used to screen potential gamete donors are critical to the success of the program. Screening affects the health of the donor, the recipient and the offspring. There are three components to donor screening and they include: (1) insuring that the donor will not incur undue physical or psychological risk, (2) insuring that the donor will not transmit infectious disease to the recipient, and (3) genetic screening to insure that there is no undue risk of the transmission of heritable diseases to the offspring.
The physical assessment of donors is designed to screen for overall health, reproductive health and potential, infectious diseases, substance abuse and finally, genetically inheritable diseases. On May 25, 2004, the US Food and Drug Administration (FDA) became involved in the practice of gamete donation by publishing, “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products,” in the Federal Register. The purpose of these rules is to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases. A partial overview of the rules follows.
Categories of reproductive donors:
There are three categories of reproductive donors subject to three different sets of requirements.
- Anonymous donor- to whom all relevant donor-eligibility screening and testing requirements apply. Anonymous semen donors must pass all screens and tests required under the new rule. A new test specimen from these donors must be collected at least six months after their semen donation and it must test negative for relevant communicable diseases in order for the semen donation to be eligible. The semen donation must be quarantined until this re-testing is complete.
- Directed reproductive donor- whose reproductive cells and tissue may be used even if the donor is determined ineligible. A directed donation involves the designation of a specific potential recipient, but does not involve a sexually intimate partner. The distinction was made between directed reproductive donors and anonymous donors to respect the existence of relationships between people who know each other and have made a joint decision for the recipient to conceive a child. Directed donations of semen are excepted from the six-month retesting requirement applicable to anonymous donations.
- Sexually intimate partner- for whom testing and screening are not required.
Cryopreserved reproductive cells or tissues (sperm, eggs, or embryos) originally collected and stored for one’s own use or for use by a sexually intimate partner may later be used for a directed donation provided additional donations are unavailable and appropriate measures are taken to screen and test the donor(s) before transfer of the tissue to the recipient.
Testing and Screening Requirements
Screening
Virtually all donors other than sexually intimate partners must be screened for risk factors and clinical evidence of communicable diseases. This screening requires a review of relevant medical records, including a donor medical history interview and physical exam. The screening for donors of reproductive cells or tissues must specifically address risk factors for, and evidence of:
- HIV
- Hepatitis B
- Hepatitis C
- Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob)
- Treponema pallidum (syphilis)
- Communicable disease risks associated with xenotransplantation (The surgical transfer of cells, tissues, or especially whole organs from one species to another)
- Chlamydia trachomatis; and Neisseria gonorrhea
In addition, donors of viable leukocyte-rich cells or tissue (which includes semen but not oocytes or embryos), also must be screened for:
- Risk factors for relevant cell-associated communicable disease agents, including HTLV.
Testing
In addition to the screening described above, donor specimens must be tested in a CLIA certified (or CLIA-exempt) lab for certain communicable diseases. Virtually all donors of reproductive cells or tissues, other than sexually intimate partners, must be tested for the following:
- HIV-type 1
- HIV-type 2
- Hepatitis B
- Hepatitis C
- Treponema pallidum
- Chlamydia trachomatis; and Neisseria gonorrhea
(Note: in the case of oocytes retrieved through non-vaginal laparoscopy, and therefore not exposed to the genitourinary tract, testing for chlamydia and gonorrhea is not required)
Donors of viable, leukocyte-rich cells or tissue (which includes semen but not oocytes or embryos) also must be tested for:
- HTLV-type I
- HTLV-type II
- CMV
Timing of Testing
Specimens for donor testing must be collected at the time of recovery of cells or tissues from the donor or, if this isn’t feasible, collection may be done up to 7 days before or after recovery. Donations from anonymous semen donors must be quarantined until donors are retested and again determined eligible at least 6 months after the date of donation. With respect to anonymous donation of embryos, a donor-eligibility determination must have been made for both the oocyte donor and the semen donor at the time the embryo was created.
Quarantine Requirements
Eggs and embryos need not be quarantined. However, semen must be quarantined for six months. The six-month quarantine requirement and the re-testing requirement apply only to anonymous semen donors. Also, you do not have to obtain a specimen for testing at each donation from a repeat anonymous donor, so long as the initial specimen was tested and you do not release any of the donations until after the donor has been retested at least six months post-donation.
These rules are designed to protect the public and to increase public confidence in the new technologies. FDA representatives are authorized to make random inspections. Compliance is not voluntary and any person found to be in violation may be punished by imprisonment for up to one year and fined $100,000 if a death has not resulted, or up to $250,000 if a death has occurred. Organizational defendants can be fined up to $200,000.
References:
FDA Regulations on Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products. Available at: http://www.fda.gov/cber/rules/hctdnr.pdf. | 
