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Cryobank Regulations and Statistics
Sperm Bank Fundamentals
The following background information on sperm banking was prepared by and agreed upon by leaders 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 continual basis.
In addition to federal regulation, many sperm banks are also licensed and inspected by individual states that have instituted state regulations.
Sperm banks also comply with the guidelines and standards of the American Society of Reproductive Medicine (ASRM).
Notwithstanding the regulatory oversight of government agencies and professional associations, most sperm banks exercise self-regulation to comply with the highest medical and ethical standards. In fact, most major sperm banks performed more tests than 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.
Limitations on Donor Distribution:
NW Cryobank limits the total number of births for any donor. Our decision is based on the following criteria.
1. When 25 family units (children from the same donor living in one home) have been reported, specimens from that particular donor will be restricted and offered only to family units with a child(ren) by the same donor.
2. If the total number of vials sold reaches our internally designated limit, the donor will be exited from the program.
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).
In order to help us monitor the number of births associated with any donor, it is important that everyone be diligent in reporting their pregnancies. Click here to Report a Pregnancy
Donor Information: As part of the screening process to determine donor eligibility, sperm banks gather an extensive family (three generations) and personal medical history. In addition, all donors are tested for a wide array of infectious diseases every six months.
Most sperm banks also perform chromosome analysis and test for many common genetic diseases in the general population such as cystic fibrosis in the general population and genetic conditions specific to certain ethnic groups (i.e. sickle cell trait in African Americans). Donors are interviewed extensively to check for consistency and accuracy of reported information. In addition to the screening and testing to establish medical eligibility, sperm banks also offer non medical information on its donors such as childhood photos, personality tests, audio interviews, staff impressions and personal profiles. The FDA requires that donor information be maintained for ten years, although most sperm banks keep such information indefinitely.
Donor Anonymity: The maintenance of donor anonymity is essential to the availability and quality of donors. There are those who believe that the identity of all donors should be known, and such disclosure is, in fact, required in a number of countries such as the United Kingdom and Australia. However, the consequence of this requirement is a severe shortage of donors, as most donors wish to remain anonymous. However, the industry is sensitive to the desire by some for known donors as an alternative to anonymous donors. Consequently, now most of the major sperm banks offer donors who have agreed to have their identities disclosed to their offspring at age eighteen. Interestingly, known donors are not selected more often than anonymous donors.