A controlled comparison of the efficacy of clomiphene citrate in male infertility.

To determine whether clomiphene citrate (CC) improves fertility in oligospermic men, 23 men with sperm concentrations between 0.5 and 20 million sperm per milliliter; normal serum gonadotropins and testosterone; and a presumptively fertile partner were enrolled in the study. After a 3-month control period, patients were randomly prescribed CC, 25 mg/day; or placebo, 1 tablet/day, for 12 months. The pregnancy rates for the CC group and the placebo group were 9.09% and 44.44%, respectively (not significant). During the treatment phase, the CC group had significantly higher levels of luteinizing hormone (LH) serum, follicle-stimulating hormone (FSH), testosterone (T), and estradiol than the placebo group. CC treatment also resulted in greater LH, FSH, and T responses to gonadotropin-releasing hormone (GnRH). There were no differences between the placebo and CC groups for the sperm penetration assay or semen parameters. The authors conclude that CC is not a useful drug in the treatment of male infertility.

RCT Entities:   Population Interventions Outcomes