Combination Clomiphene Citrate And Antioxidant Therapy For Idiopathic Male Infertility: A Randomized Controlled Trial

UroToday - Empirical medical treatment for idiopathic male factor infertility is a controversial issue. Several medications are used empirically for the treatment of idiopathic male factor infertility, including follicle stimulating hormone (FSH), antiestrogen, L-carnitine, and antioxidants. In this study, we attempted to evaluate the effectiveness of the combination of clomiphene citrate and vitamin E in the management of men with idiopathic infertility.


The study was designed as a prospective, randomized, placebo-controlled trial. The setting was the outpatient Andrology clinic, in Cairo University Hospitals. The study included sixty infertile men with idiopathic oligoasthenozoospermia. 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 continued for 6 months. The main outcome measures were the pregnancy rate and variations in semen parameters. The study followed an intention-to-treat analysis.


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 insignificant changes in total sperm motility, percentage of abnormal forms and semen volume in the combination treatment group as compared to the control group.


We conclude that 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, with normal testicular size, normal or low normal FSH, and no known male or female factors. The treatment protocol is inexpensive, safe and easy to administer.


Hussein Ghanem, MD, Osama Shaeer, MD, and Amgad El-Segini, MD as part of Beyond the Abstract on UroToday.


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