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 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.