There are 2 categories of sperm donors. Anonymous sperm donors are the majority of donors used clinically. In the USA, these donors are generally unknown to the recipient, although most recently, some commercial sperm banks have offered identity release of donors. Directed or known donors are “known” to the recipient and her partner if applicable. The sperm from a directed donor is directed only to a specific recipient and does not become part of the general sperm bank inventory.

In the UK, however, the Human Fertilisation and Embryology Authority (HFEA) has maintained since 1991 a record of all births from assisted conception from licensed UK fertility clinics [22]. Children born as a result of sperm donation have a legal right to donor information, including physical characteristics, birth year and place, ethnicity, information about the donor’s own biological children, marital status, medical history, and identifying information [22]. Thus, the donor anonymity is eliminated. Any commercial sperm bank that ships donor semen into the UK must agree to the identity release, and the donors must sign a consent to the release of this information. In France, gamete donation has been anonymous, yet, in most other European countries, there has been a trend toward identity release [23].

Directed or known sperm donors must be screened and tested in the same manner as anonymous sperm donors [2, 5, 10, 11, 18–21], the only real difference being the fact that the donor is known to the recipient. Additionally, if a donor is ineligible due to high-risk behavior, a known donor can still be used for insemination of the known recipient if approved by the sperm bank medical director [10, 11]. There would be no medical approval if there is positive serological testing, especially positive for human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), or hepatitis [10]. However, the US Food and Drug Administration (FDA) allows use of specimens from a known sperm donor that tests positive for communicable diseases, if the recipient is counseled and her physician agrees to the insemination [11]. The general standard of practice in the industry, however, is to strongly urge recipients not to use such known donors. In all cases, the sperm bank must document with signed consent or risk acknowledgement that the recipient has been counseled and agrees to the potential risk to her and the offspring if an ineligible known donor is used for artificial insemination. This includes if a known donor is found to be carrier of a recessive genetic condition or there is a medical condition in the family history. With known donors, the 180-day quarantine and retesting are not required, but a risk acknowledgement must be signed by the recipient and partner (if applicable) [11, 12].

With both types of donors, the screening and testing process is basically the same. The American Society for Reproductive Medicine (ASRM) [21], the FDA [11], and state regulations (i.e., [10, 24, 25]) have regulations that must be followed by sperm banks providing donor sperm for clinical use. Both New York State [10] and California [24] require these facilities to apply for and be granted a state tissue bank license in order to operate in the state or ship donor sperm into the state. All states require FDA registration in order to operate in the USA.

Sperm donors are often recruited by advertisement at local college campuses, as well as commercial online advertisers. Donors are also recruited through friends who may be currently participating as sperm donors. According to most guidelines, sperm donors should be of legal age, but generally less than 40 years of age [10, 20, 21] to minimize risks due to advanced paternal age. All applicants are required to fill out an extensive medical, family/genetic, and social history questionnaire. The purpose of this screening questionnaire is to determine any possible risks of genetic or medical conditions in the family history or ethnicity that could be passed on to offspring or increase the risk of a medical condition in offspring. The applicant’s fertility history is documented, although past fertility, being beneficial, is not a requirement for participation. Equally important is the applicant’s sexual and social history. Donors are screened for high-risk behaviors such as sexual orientation, multiple sexual partners, sexual activities in exchange for drugs or money, nonprescription drug use, tattoos, and body piercings, for example, to provide a better understanding of the potential donor’s lifestyle. The medical history questionnaire is reviewed carefully by the sperm bank staff and medical director, and if acceptable, the applicant will have an in-person interview and thorough physical examination to assess any physical evidence of high-risk behaviors. Applicants who have lived in or traveled to certain European countries for extended periods of time are rejected due to increased risk of variant Creutzfeldt–Jakob disease [11, 21]. A physical examination of the donor is performed to evaluate the donor based on criteria specified in FDA regulations, California, and New York requirements (e.g., tattoos, body piercings, evidence of high-risk behavior, and signs of HIV infection, genetic diseases) [10, 11]. The physical examination is part of the donor screening process in conjunction with genetic disease screening and serological testing for infectious diseases.

If the medical, genetic, and social histories are acceptable, the applicant will submit 3–5 specimens for qualification of acceptable sperm count, motility, and cryosurvival. These specimens are for testing purposes only and are thus not added to the inventory. If acceptable, the potential donor will have serological testing for evidence of infectious diseases [10, 11, 20, 21]. Donors are tested for HIV 1, 2 antibody screen, HTLV I/II antibody screen, hepatitis B (HBV) surface antigen and core antibody, hepatitis C virus, syphilis, Neisseria gonorrhea, cytomegalovirus (CMV) total antibodies (with reflex to IgG and IgM), Chlamydia trachomatis, and nucleic acid test (NAT) for HIV-1, HCV, and HBV. The blood type and Rh factor are also assessed and also hemoglobinopathy evaluation (including complete blood count (CBC) and screening for sickle cell anemia and thalassemia). Initial serological testing must be performed within 7 days of the first specimen [11] that will be placed into inventory.

Upon receipt, all test results are reviewed and recorded in the donor’s file by 2 separate staff members. Positive results are submitted immediately to the medical director, who may determine whether the donor needs to be referred for counseling, retesting, or treatment. Positive results would make a person ineligible as an anonymous sperm donor. However, a positive CMV is not an automatic rejection. A donor can be accepted even with a positive CMV total antibody test. The sperm bank must have a specific policy regarding CMV status, including follow-up for IgG and IgM status, and subsequent routine testing for CMV total antibody. All anonymous donor sperm specimens must be held in quarantine for a minimum of 180 days, at which point the testing is repeated, and if negative, such specimens can be released for clinical use. Furthermore, anonymous donors are required to have a repeat physical examination and a repeat history questionnaire every 6 months while actively participating as a sperm donor [11]. In addition, donors fill out a risk factor questionnaire at each visit to determine any high-risk behaviors since previous participation [11]. If a donor is positive for N. gonorrhea or Chlamydia, he may reenter the program following treatment, a negative follow-up test, and a deferral period of at least 1 year. [11].

All anonymous sperm donors are tested for genetic conditions and carrier status as a prerequisite for participation. The genetic testing can be performed with initial serological testing, or prior to the first release of specimens for clinical use. Commercial genetic testing laboratories offer extensive panels for hundreds of recessive diseases, but not all are required by regulatory and professional agencies. In fact, the FDA does not require genetic testing, being only concerned with communicable disease transmission. State regulatory agencies and professional associations (such as the ASRM) require genetic testing based on the donor’s ethnic group [10, 21]. Genetic tests are required for carrier status for cystic fibrosis, Tay-Sachs disease, hemoglobinopathy/thalassemia/sickle cell anemia. Most sperm banks currently require the genetic testing for all donors regardless of reported ethnic group since mutations/deletions might become evident even if a certain ethnicity is far removed from the first- or second-degree blood relatives.

Genetic testing of sperm donors remains in the forefront of discussion by donor facilities and professional organizations in the USA and internationally. With genetic testing of sperm donors comes the issues of appropriate consenting of the donor for the genetic testing, limitations of the tests, potential implications for the donors’ own children, and counseling of the donor in the case of positive carrier testing [26]. Even with extensive genetic testing, the risks for de novo mutations, multifactorial disorders, or undiagnosed disease cannot be reduced or eliminated with any genetic screening procedures [27–29]. There have been several lawsuits against commercial sperm banks and testing laboratories for incomplete testing as well as errors in testing.

Although US federal regulations do not address the issue of numbers of offspring per donor, standard of care requires that facilities establish a policy of number of offspring per donor, not including full blood siblings. The New York State regulations do not specify an acceptable number of offspring per donor [10], but the American Society for Reproductive Medicine suggests that there should be no more than 25 births in a population of 800,000 to avoid increased risk of consanguineous conception [21]. The Human Fertilisation and Embryology Authority (HFEA) in the UK limits the number of families a single donor can help to create at a limit of 10 [22].

It is essential to consent the donor in order to ensure that the applicant understands his responsibilities as a sperm donor, the confidentiality of participation, and including his denial of risk factors for communicable and genetic diseases [10, 21]. Furthermore, the donor must understand that his sperm is being used to create embryos that would be transferred to recipients in either heterosexual or same sex couples, single women, used for research, or discarded [11]. The FDA also requires that records pertain to donor screening and testing be maintained for at least 10 years [11, 21], while the New York State regulations require that records be maintained for 12 years if no pregnancy has occurred and 25 years where a pregnancy has occurred with that donor’s sperm [10].