Male infertility remains a difficult problem to treat, particularly because many patients and physicians prefer modern assisted reproductive technologies such as in vitro fertilization (IVF). A major reason for this difficulty is the limited clinical evidence and relatively sparse drug development focused on male-infertility therapies. Clinical data from randomized controlled trials (RCTs) is rare due to several factors, with very low patient accrual being one of the most difficult hurdles that researchers encounter. This is often due to the time-sensitive nature of conception, according to GlobalData, a leading intelligence and productivity platform.

Male infertility can be caused by numerous factors, including poor lifestyle, genetic factors, and certain drug treatments such as testosterone therapy or chemotherapy. However, a significant percentage of male infertility cases are idiopathic, with no identifiable cause. Male infertility can be further subdivided into oligo-, astheno-, terato-, and azoospermia. Azoospermia is considered the most difficult to treat, as it indicates total absence of sperm in a patient.

David Beauchamp, Pharma Analyst at GlobalData, comments: “Unlike other clinical trials, it is especially difficult to recruit for infertility trials because of the time-sensitive nature of conception. Couples trying to conceive, especially if they are older, are often unwilling to wait six or more months for a trial treatment arm to conclude. If possible, couples opt for IVF or similar treatments, as there is a significantly higher chance of conception with these methods.”

There is no obvious solution to address the difficulties of male infertility clinical trial design. This is a major reason why current male infertility treatment regimens remain fragmented across the US and Europe. Off-label use of other drugs is common, and the efficacy of these drugs, especially in idiopathic patients, remains uncertain. According to GlobalData, there are currently only five drugs undergoing clinical trials for male infertility. Three of these drugs are novel therapies.

Beauchamp concludes “In the near future, it seems likely that male infertility will continue to remain as unmet need for patients trying to conceive without relying on assisted reproduction technologies. Until more promising pharmaceutical options are developed and a cause for idiopathic infertility is found, pharmaceutical interventions are unlikely to provide a solution for these patients.”