On-label and off-label drugs used in the treatment of male infertility.

Infertility affects 6.1 million U.S. couples-representing 10% of reproductive-age adults and 15% of all couples trying to conceive. Half of the time, infertility is the result of an abnormal semen analysis or other male factors, with 40%-50% of these infertile men diagnosed with idiopathic or nonclassifiable infertility. While the role of hormone therapy for men with an identified abnormality is well defined, the literature remains inconclusive and controversial regarding hormone manipulation using empirical (off-label) medical therapies for men with idiopathic infertility. This manuscript reviews the commonly used off-label medications used to treat idiopathic male factor infertility: clomiphene citrate, letrozole/anastrozole, exogenous androgens, and pentoxifylline.