The Food and Drug Administration is making plans to significantly expand the number of gay and bisexual men who could donate sperm anonymously.
Longstanding agency rules ban anonymous sperm donations by men who acknowledged having sex with other men during the previous five years to reduce the risk of spreading pathogens including HIV, the virus that causes AIDS.
Under a proposal it is drafting, the FDA would eliminate the broad ban and instead adopt more pointed screening questions to assess HIV risk, according to people familiar with the agency’s deliberations.
The proposed changes would also apply to donations of other cells and tissues, such as heart valves and ligaments.
The FDA is planning to finalize its proposal by summer. If the White House approves, the new guidelines could go into effect by the end of this year.
Women whose male partner is infertile or who don’t have a male partner rely on donated sperm to become pregnant. Doctors may inject the sperm directly into a woman’s uterus or use it to fertilize eggs outside of the body, known as in vitro fertilization, or IVF.
IVF and other assistive reproductive technologies now account for some 2%, or about 86,000, of infants born in the U.S. each year, according to the U.S. Department of Health and Human Services.
The ban on sperm donations from men who had sex with other men stemmed from the HIV epidemic in the 1980s. Health authorities were concerned about the accuracy of HIV testing at the time. They put in place the ban to reduce the risk that virus would spread through sperm.
Medical organizations and gay-rights groups have pushed FDA in recent years to ease its rules, saying HIV tests are now more accurate and are enough to keep sperm donation safe combined with other precautions.
Precautions include testing donors at least twice, six months apart, for HIV. Donors must test negative both times before sperm vials are released.
The current policy “is based on outdated thinking and is contrary to evidence-based science, and serves to perpetuate discrimination and stigma,” a coalition of groups including the American Medical Association and nonprofit National Center for Lesbian Rights wrote to the FDA last year.
Changes to the sperm donation guidelines would follow a similar move last year allowing more gay and bisexual men to donate blood.
Like the new blood rules, the sperm-donation changes would replace the wider blanket ban with a series of screening questions to assess an individual’s risk, the people familiar with the FDA’s deliberations said.
Alice Ruby, executive director of the Sperm Bank of California in Berkeley, who has written letters to the FDA urging it to update the donation rules, said “people should be evaluated based on their individual risk rather than their identity.”
Expanding the donor pool could address shortages. Many people who use sperm banks to create their families are gay, lesbian, bisexual or queer. Some seek out donors who are also LGBTQ.
Yet sperm banks have said they turn away applicants because they said they had a male sex partner during the past five years.
Sperm banks have been experiencing shortages of donors, especially donors of color. The Covid-19 pandemic exacerbated the problem as young professionals and university students, who often compose a large portion of prospective donors, left cities.
