Efficacy and safety of recombinant human follicle-stimulating hormone in men with isolated hypogonadotropic hypogonadism

Objective: To assess the efficacy and safety of recombinant human follicle-stimulating hormone (rhFSH, follitropin alpha) in increasing sperm concentration in 26 men with severe isolated hypogonadotropic hypogonadism. (IHH). Design: Clinical and endocrine studies using an open design. Setting: Six university clinical sites in three European countries. Patient(s): Azoospermatic patients aged 16 to 48 years with IHH. Intervention(s): Patients received hCG for up to 6 months before 18 months of treatment with rhFSH. Sperm count, motility, and morphology were assessed every 3 months. Main Outcome Measure(s): Achievement or a sperm concentration of 1.5 X 10(6)/mL. Result(s): Spermatogenesis was achieved in 15 of 19 patients who could be evaluated, 12 achieving a sperm concentration of greater than or equal to 1.5 x 10(6)/mL. Conclusion(s): With hCG, rhFSH is effective in initiating spermatogenesis in patients with IHH, and is well tolerated. (Fertil Steril(R) 2002;77:270-3. (C) 2002 by American Society for Reproductive Medicine.).