Donor sperm, and what "FDA screened" actually means
It means a specific list of infections. It does not mean vetted.
What the results look like. In 8,922 donor inseminations in 3,333 consecutive women at one UK centre, the delivery rate was 8.9% per cycle. Crude cumulative live birth was 29% under 35, 23% at 35 to 37, 21% at 38 to 39, and 12% at 40 to 42. A plateau was reached after six cycles, with little benefit beyond that up to age 40, and about three attempts being reasonable at 40 to 42. There was no significant difference in cumulative live birth between single women and women in same-sex couples.
There is no US national registry of donor insemination outcomes, because insemination falls outside the reporting law that covers IVF. If you are quoted a US donor insemination success rate, ask where it came from.
What the screening is. Donor gametes are regulated in the United States as human tissue. The requirements are a defined list of infectious disease screening and testing:
- Screening and testing for HIV-1, HIV-2, hepatitis B, hepatitis C and syphilis
- Screening for human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease
- Additional screening and testing of reproductive donors for chlamydia and gonorrhoea
- Testing for cytomegalovirus, with a written procedure governing release of a reactive sample
- For non-directed sperm donors, a six-month quarantine with retesting of a new sample before release, which is why donor sperm is frozen
There are also exemptions worth knowing: reproductive cells donated by a sexually intimate partner are exempt from the donor eligibility determination entirely, and material falling under those exemptions has to be labelled
NOT EVALUATED FOR INFECTIOUS SUBSTANCES.
Screening beyond that infectious disease floor, including genetic carrier screening and psychological assessment, is set by professional society guidance rather than by law, and by individual sperm banks. Ask what specifically was done, and by whose standard.