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Objectives: To determine the effectiveness of gonadotrophins administration to men with idiopathic subfertility on spontaneous pregnancy rate and in assisted reproductive techniques. Search strategy: We searched the all relevant databases. Searches were not limited by language. The bibliographies of included, excluded trials and abstracts of major meetings were searched for additional trials. Authors and pharmaceutical companies were contacted for missing and unpublished data. Selection criteria: Truly randomized controlled trials where gonadotrophins were administered for the treatment of idiopathic male subfertility with reporting of pregnancy rates were included in the review. Data collection and analysis: Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. Main results: Five RCTs with 426 participants were included in the analysis. Compared to placebo or no treatment FSH showed a significantly higher overall pregnancy rate per couple randomized during treatment period (OR 1.8, 95% CI 1.03 to 3.17, NNT 14, 95% CI 8 to 100). Follow up of patients up to three months post-treatment also showed a significant difference in favor of FSH treatment (OR 1.92, 95% CI 1.15 to 3.20, NNT 11, 95% CI 6 to 50. However when patients were followed up for extended period over three months post-treatment results showed a non-significant overall pregnancy rate difference in favor of FSH treatment (OR 1.52, 95% CI 0.99 to 2.33). Compared to placebo or no treatment there was non-significant difference in pregnancy rates after IUI/IVF/ICSI per couple randomized either during the treatment period, during treatment and up to three months follow-up, when the follow-up period was extended to more than three months post-treatment. The spontaneous pregnancy rate per couple randomized showed a favorable and significant difference in the FSH group over placebo or no treatment. OR was 3.99, 95% CI 1.80 to 8.82, NNT 11, 95% CI 7 to 25. Reviewers' conclusions: The number of trials and participants is not enough to draw final conclusions. However, analysis of the five included trials showed that in men with idiopathic subfertility treated with FSH there is a significant increase in the overall and spontaneous pregnancy rates per couple. This increased pregnancy rate is evident during the treatment period and within three months post-treatment. This increase is not significant in couples who undergo assisted conception.

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