Male infertility can be caused by numerous lifestyle factors, including poor lifestyle, genetic factors, or specific drug treatments such as testosterone or chemotherapy. However, a significant percentage of male infertility cases are idiopathic and have 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.
In clinical trial design, male infertility trials often suffer from low participant accrual. 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 will opt for IVF or similar treatments, as there is a significantly higher chance of conception with these methods.
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There is no obvious solution for addressing the difficulties of male infertility clinical trial design. This is a major reason why current male infertility treatment regimens remain so 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 very uncertain.
In the near future, it seems likely that male infertility will continue to be an unaddressed problem for patients trying to conceive using options outside of 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.
