Combination clomiphene citrate and antioxidant therapy for idiopathic male infertility: a randomized controlled trial

Objective: To assess the effect of treatment with a combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant on the incidence of pregnancy and sperm variables in men with idiopathic oligozoospermia and infertility. Design: Prospective, randomized, placebo-controlled trial. Setting: The outpatient andrology clinic at a university hospital. Patient(s): Sixty infertile men with idiopathic oligoasthenozoospermia. Intervention(s): Patients were randomly assigned to two treatment groups: a group receiving the combination of clomiphene citrate (25 mg/day) and vitamin E (400 mg/day; n = 30) against a placebo group (n 30). Treatment was maintained for 6 months. Main Outcome Measure(s): Pregnancy incidence and variations in semen parameters. Result(s): A significantly higher pregnancy rate was found among the combination treatment group in comparison to the control group. The odds ratio was 3.76 and the 95% confidence interval was 1.03-13.64, with a 36.7% pregnancy rate (11/30) in the combination treatment group compared with 13.3% pregnancy rate (4/30) in the control group. The trial showed a significantly higher increase in sperm count and progressive sperm motility with nonsignificant changes in total sperm motility, percentage of abnormal forms and semen volume in the combination treatment group as compared to the control group. Conclusion(s): The combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant can significantly increase the pregnancy rate and improve sperm count and progressive sperm motility in cases of idiopathic oligoasthenozoospermia. (Fertil Steril (R) 2010;93:2232-5. (C)2010 by American Society for Reproductive Medicine.)