Background: FSH plays a crucial role in human reproduction. Treatment with gonadotrophins has been shown to be effective in males affected by hypogonadotrophic hypogonadism. The success of this treatment has brought about the utilization of the same therapy in infertile oligozoospermic subjects, aimed at obtaining increased sperm count. This physiological role in spermatogenesis has induced various attempts to treat idiopathic oligozoospermic men with FSH, often inducing the restoration of normal spermatogenesis and spontaneous pregnancy.
Objective: To evaluate clinical efficacy of recombinant FSH in male infertility.
Methods: Evaluation of pharmacokinetic, pharmacodynamic properties, efficacy and safety of this hormone preparation, on the basis of the data published in literature.
Conclusions: Recombinant FSH is effective, safe and well tolerated. Treatment with this hormone may represent a valid tool for infertile men. However it should be performed on selected patients utilizing some predictive parameters able to identify a priori responder subjects with high probability.