Fertility preservation is a crucial treatment for patients who wish to have biologically related children but may be facing infertility due to a medical condition or an impending treatment, such as chemotherapy.
Investigators at Brigham and Women’s Hospital, Massachusetts General Hospital, and Harvard Medical School have identified a hidden inequity in fertility preservation care. Due to existing federal policies, certain sexually and gender diverse populations may face disparities when seeking fertility preservation.
“In looking at FDA policies, we discovered that gay men are often grouped under this ‘anonymous donor’ category, which puts an increased testing burden on them and makes fertility preservation a much more difficult service to access,” says Andrew Shin, an M2 student at Harvard Medical School and first author on their paper published in LGBT Health. “It’s a de facto discrimination issue based on sexual orientation and gender identity because heterosexual couples, for instance, don’t experience this issue at all.”
The donor labeling system and associated policies, designed to mitigate infectious disease transmission, inadvertently result in barriers to fertility preservation among patients whose partner is also capable of producing sperm. With relatively few patients falling under this category, it’s a disparity that often goes unrecognized.
“This is a niche, hidden inequity that even people doing a fair bit of work in this space have missed,” says Alex Keuroghlian, MD, MPH, a psychiatrist in the Mass General Department of Psychiatry. “It took a fresh eye from Andrew to connect the dots and express that this is concerning: the policy is rigged against an already minoritized population.”
Anonymous Donor Category Results in Barriers to Preservation
Prospective donors whose partner is also capable of producing sperm, which includes but is not limited to transfeminine people and gay cisgender men, often turn to third party reproduction when family planning. Most people in this category do not know their intended surrogate or oocyte donor at the time of preservation, especially in the case of a sudden cancer diagnosis. They will therefore almost always be categorized as an “anonymous donor,” subjecting them to more rigorous infectious disease testing than “directed donors”—those who know and are known by their intended recipient. Donors to sexually intimate partners are exempt from testing, as it is assumed they share the same disease profile.
Both directed and anonymous donors require an initial round of disease screening and testing, but anonymous donors must complete a second round of testing after a minimum 6-month quarantine of their tissue samples. Some patients, specifically those with serious illness, may not have the ability to complete this additional testing.
“We’ve also found that individual facilities may not have the capacity to carry out anonymous donor testing,” Shin says. “This is a very little-known inequity, so providers could mistakenly refer patients to certain services without realizing that those facilities will not see those patients.”
Prospective donors in this category may be turned away completely or referred to a private fertility clinic, where they would be required to pay the cost of testing, screening, and tissue quarantine.
Martin Kathrins, MD, a urologist and associate surgeon in the Brigham’s Department of Urology, recalls specific instances where his patients experienced this disparity.
“Most patients that would be affected are likely unaware of this policy,” he says. “I’ve seen patients get angry when they’re faced with this. Providers treating men looking at fertility preservation, in reproductive medicine or even in the cancer space, need to be aware of what the current FDA regulations are. It’s our responsibility to accurately guide patients to the location and services they need.”
Proposing Policy Changes for Equitable Care
The investigators outline several policy changes to reduce these barriers to fertility preservation. They suggest the FDA mandate that all practices provide equal access to preservation, regardless of donor status. This would require facilities to either partner with other locations or build internal capacity for anonymous donor testing.
They also propose that the donor classifications be expanded to include a new “third party reproduction donor” category. “Anonymous donor,” the investigators argue, is a blanket term that currently encompasses a wide range of variable patient medical histories and disease profiles, inadvertently subjecting specific patients to more rigorous testing. Surrogates and intended parents often maintain close relationships throughout the pregnancy, so a new category would more accurate and validating for those patients.
A significant hurdle to preventing these disparities is that federal policy change can take years. Blood donation restrictions for gay and bisexual men were only recently lifted in 2023 after years of social movement, the guidelines now taking an “individual risk-based” approach rather than restricting donors based on sexual or gender identity. Fertility preservation policies could be similarly revised, the authors suggest, to include a more in-depth review of patient medical history that better identifies individual disease risk.
A Physician’s Role in Advocating for Their Patients
While federal policy change can take years, the authors emphasize that physicians have a large role to play in improving the patient experience and advocating for policy change.
“This system is not going to change tomorrow, or maybe not anytime soon, unfortunately,” Dr. Kathrins says. “I would like to see future patients avoid the frustration of being confronted with a ‘no’ by having them either rely on a provider who can point them to an appropriate banking site, or to be armed with the right questions to make sure they can pursue services at a given site.”
“The burden shouldn’t be placed on marginalized communities,” adds Dr. Keuroghlian. “We often underestimate our power in medicine to change things. Physicians ought to expand their view of their own role toward not just delivering care within the system as it’s set up, but also as physician advocates for our communities.”