Sperm Banking Background Fundamentals
1. Regulation: Sperm banking, which includes the screening and testing of sperm donors, is a regulated activity, contrary to the understanding of many. 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 cryobanks have been audited annually for compliance by the FDA through on-site inspections.
In addition to federal regulation, most major cryobanks 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, cryobanks also have conducted operations consistent with the guidelines of medical groups 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 cryobanks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major cryobanks were performing more than all the tests required by the FDA several years prior to the FDA’s effective date.
2. 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, a more accurate figure would be less than 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 abortion rate.) Similarly, the total number of anonymous donor inseminated births is estimated to be less than 120,000 over the last 30 years.
3. Limitations on Donor Distribution: All cryobanks use some type of standard to limit the number of births attributable to any one donor. One standard used is the guideline of the ASRM, which is currently 25 births/donor per 800,000 (1 birth per 32,000) in a circumscribed population, i.e., the population surrounding the location where donations are collected. Another method to limit the number of donor inseminated births is to establish an absolute number of births per donor, e.g., 10. Donor inseminated births are further controlled because most cryobanks require that donors participate for only six months, which limits the number of units that can be produced and distributed. Notwithstanding the standard used to limit donor inseminated births per donor, cryobanks do not limit the number of births within a family unit, thereby permitting full siblings via donor insemination.
4. Donor Information: As part of the screening process to determine donor eligibility, cryobanks gather a great deal of family (3 generations) and personal medical history. In addition, while donating, donors are given physicals every six months, and tested for a wide array of infectious diseases at least every six months. Most cryobanks also perform chromosome analysis (karyotype) and test for certain common genetic diseases such as cystic fibrosis and genetic conditions common to certain ethnic groups (e.g., sickle cell 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, cryobanks 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.
5. 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. But the consequence of this requirement is a severe donor shortage, since most donors do not want to be known. However, the industry is sensitive to the desire by some for “known” donors as an alternative to anonymous donors. Consequently, now most major cryobanks offer donors who have agreed to have their identities disclosed to their offspring at age eighteen. On the other hand, many more want their donors to remain anonymous, and therefore cryobanks do not think it is wise to destroy the anonymous status for ALL donors. To do so would breach the contracts and representations made to donors and to those who selected an anonymous donor, and eliminate for a large segment of potential users of sperm donors the much wanted option to select a forever anonymous donor.
In addition to federal regulation, most major cryobanks 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, cryobanks also have conducted operations consistent with the guidelines of medical groups 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 cryobanks have exercised self-regulation consistent with the highest medical and ethical standards. In fact, most major cryobanks were performing more than all the tests required by the FDA several years prior to the FDA’s effective date.
2. 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, a more accurate figure would be less than 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 abortion rate.) Similarly, the total number of anonymous donor inseminated births is estimated to be less than 120,000 over the last 30 years.
3. Limitations on Donor Distribution: All cryobanks use some type of standard to limit the number of births attributable to any one donor. One standard used is the guideline of the ASRM, which is currently 25 births/donor per 800,000 (1 birth per 32,000) in a circumscribed population, i.e., the population surrounding the location where donations are collected. Another method to limit the number of donor inseminated births is to establish an absolute number of births per donor, e.g., 10. Donor inseminated births are further controlled because most cryobanks require that donors participate for only six months, which limits the number of units that can be produced and distributed. Notwithstanding the standard used to limit donor inseminated births per donor, cryobanks do not limit the number of births within a family unit, thereby permitting full siblings via donor insemination.
4. Donor Information: As part of the screening process to determine donor eligibility, cryobanks gather a great deal of family (3 generations) and personal medical history. In addition, while donating, donors are given physicals every six months, and tested for a wide array of infectious diseases at least every six months. Most cryobanks also perform chromosome analysis (karyotype) and test for certain common genetic diseases such as cystic fibrosis and genetic conditions common to certain ethnic groups (e.g., sickle cell 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, cryobanks 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.
5. 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. But the consequence of this requirement is a severe donor shortage, since most donors do not want to be known. However, the industry is sensitive to the desire by some for “known” donors as an alternative to anonymous donors. Consequently, now most major cryobanks offer donors who have agreed to have their identities disclosed to their offspring at age eighteen. On the other hand, many more want their donors to remain anonymous, and therefore cryobanks do not think it is wise to destroy the anonymous status for ALL donors. To do so would breach the contracts and representations made to donors and to those who selected an anonymous donor, and eliminate for a large segment of potential users of sperm donors the much wanted option to select a forever anonymous donor.
posted by Kathleen, Contributing Editor at
1:50 PM
1 Comments:
Sorry if I'm a tad ignorant as to how 'blogs' work but ..... who wrote this piece and where did the information come from - are there reviewed sources I could access?
I am a PhD student doing research into 'sperm banking'.
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