Sperm Banking Background Fundamentals
The following background information on sperm banking was prepared by and agreed upon by the leading companies in the industry. Its purpose is to provide basic information about some of the key elements of a sperm bank's operations and influence, and to further understanding by providing accurate and consistent information.
- Regulation: Sperm banking, which includes the screening and testing of sperm donors, is an increasingly regulated activity. Effective on May 25, 2005, the U.S. Food and Drug Administration (FDA) commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA's regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations became effective, all major sperm banks have been audited for compliance by the FDA through on-site inspections. FDA inspections will be performed on a continuing basis.
In addition to federal regulation, most major sperm banks are also licensed and inspected by several states, particularly New York, California, and Maryland. Licensing by state agencies began as early as 1992.
Although not having the force of law, sperm banks also have conducted operations consistent with the guidelines and/or standards of professional organizations such as the American Society of Reproductive Medicine (ASRM) and the American Association of Tissue Banks (AATB).
Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major sperm banks were performing more than all the tests required by the FDA several years prior to the FDA's effective date, and with greater frequency than required by the FDA and other regulatory agencies.
- Statistics: The popular press often cites the number of anonymous donor inseminated births per year at 30,000. Although no industry-wide statistics are maintained, an unpublished survey conducted by the AATB suggests that a more accurate figure would be 4,000 to 5,000 donor inseminated births per year. (This is calculated based on 1.5 vials per insemination, a 10% pregnancy rate per cycle, and a 20% spontaneous miscarriage rate.) By extrapolating this annual figure, the total number of anonymous donor inseminated births is estimated to be less than 130,000 over the last 30 years.
- Limitations on Donor Distribution: All surveyed sperm banks use some type of standard to limit the number of births attributable to any one donor. Some use the actual number of births while others use the number of family units. Fairfax Cryobank's policy is as follows: Fairfax Cryobank limits the total number of births for any donor based on the application of several criteria. Specifically, a donor's sales will cease when either of the following criteria is reached: (1) Maximum of 25-30 family units (children from the same donor living in one home) reported within the U.S.; OR (2) Total number of units sold reaches our designated limit (actual numbers are not disclosed). In addition, we also monitor the reported location of births and limit the geographic distribution of a donor consistent with the guideline of the American Society of Reproductive Medicine (ASRM). Notwithstanding the standard used to limit the number of births per donor, sperm banks do not limit the number of births within a family unit, thereby permitting full siblings via donor insemination.
- Donor Information: As part of the screening process to determine donor eligibility, sperm banks gather a great deal of family (3 generations) and personal medical history. In addition, while donating, donors are given physical examinations every six months, and are also tested for a wide array of infectious diseases at least every six months. Most sperm banks also perform chromosome analysis (karyotype) and test for many common genetic diseases such as cystic fibrosis in the general population, and genetic conditions common to certain ethnic groups (e.g., sickle cell trait for African Americans). Donors are interviewed extensively to check for consistency and accuracy of reported information. In addition to the screening and testing of donors used to establish medical eligibility to donate, sperm banks also offer other "soft" information on its donors such as childhood photos, personality tests, audio interviews, staff impressions, and personal profiles. It has been said that the amount of medical and personal information on an anonymous donor greatly exceeds the knowledge most people have of a known partner.