The Food and Drug Administration is responsible for regulating the donation of various human cells and tissues, including sperm. Title 21 in the Code of Federal Regulations, part 1271, subpart C, specifically defines who is legally permitted to donate sperm, based on health requirements. In addition to these federal requirements, some commercial sperm banks have additional voluntary health-screening requirements.
Risk Factors Questionnaire
Before you can donate sperm, you must answer personal questions to determine whether your social behavior, medical conditions or workplace exposures puts you at risk for being infected with these specific major communicable diseases: HIV, hepatitis B & C, human transmissible spongiform encephalopathy including Creutzfeldt-Jakob disease, syphilis, human T-lymphotropic virus (HTLV), chlamydia and gonorrhea. If your answers indicate that you are at risk for having these diseases, you cannot donate sperm.
Behaviors that increase your risk of these diseases include having sex with an infected person, having sex for drugs or money or injecting illegal drugs. If you have received human-derived clotting factor concentrates to treat a blood disorder, you might not be eligible to donate sperm. If you work in health care and are exposed to another person's blood from a needle stick or wound, you have an increased risk of contracting these blood-borne diseases. The FDA requires that a physician review the potential donor's answers to the risk factor questionnaire and to determine whether a potential donor is medically eligible to donate sperm.
Physical Exam
If your answers on the questionnaire do not signal disease risk factors, the next step is to undergo a full physical exam to look for signs of infection. The physician may examine your genitalia for symptoms of sexually transmitted diseases. Having tattoos or body piercings may make you ineligible to donate sperm. A physician will have to sign off on a negative physical exam before you will be able to donate sperm.
Blood and Urine Tests
The final FDA-regulated step before you can donate sperm is to take blood and urine tests to check for the presence of these communicable diseases. In order to donate sperm, all disease testing must come back negative before you can produce a sperm sample for donation. Your sample will be frozen and held in quarantine for at least 180 days, then you will be asked to repeat the lab tests to make sure the specimen in storage is free from infectious disease organisms. Sometimes a new infection is not detected by the first test. If the second test is also negative, the sample can be released for donation.
Optional Tests
Although not legally required, most sperm banks collect additional information from donors such as a four-generation medical history, psychological evaluation and some genetic screening. Dr. Barry J. Maron and colleagues reported in the Oct. 21, 2009, issue of the "Journal of the American Medical Association" the case of a 23-year-old sperm donor who unknowingly passed on a severe genetic defect to nine of 24 children conceived using his sperm. This severe heart condition, called hypertrophic cardiomyopathy (HCM), gravely increases the risk of sudden cardiac death, even in young children. Due to this case, some sperm banks are adding negative electrocardiogram screening to their list of health requirements.
