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 of 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 > or =1.5 x 10(6)/mL.
Conclusion(s): With hCG, rhFSH is effective in initiating spermatogenesis in patients with IHH, and is well tolerated.