A combined analysis of data to identify predictive factors for spermatogenesis in men with hypogonadotropic hypogonadism treated with recombinant human follicle-stimulating hormone and human chorionic gonadotropin

Objective: To compare the efficacy and safety of recombinant human FSH (r-hFSH) and hCG treatment for male hypogonadotropic hypogonadism (HH) in different populations and to identify characteristics predictive of spermatogenesis. Design: A combined analysis of data from four clinical trials. Setting: Phase III, open-label, noncomparative studies with similar designs conducted in Australia, Europe, Japan, and the United States. Patient(s): One hundred men with complete idiopathic or acquired HH. Intervention(s): Pretreatment with hCG for 3-6 months, followed by combination therapy with hCG and r-hFSH (150 IU three times weekly) for up to 18 months. Doses of r-hFSH were adjusted according to spermatozoa count until the maximum dose was reached. Main Outcome Measure(s): The primary efficacy endpoint was a spermatozoa concentration of >= 1.5 x 10(6)/mL. Result(s): A total of 81 men remained azoospermic but achieved normal serum T concentrations after hCG pretreatment. Of these, 68 (84.0%) achieved spermatogenesis and 56 (69.1%) achieved spermatozoa concentrations >= 1.5 x 10(6)/mL. Large baseline mean testicular volume, low body mass index, and advanced sexual maturity were predictors of good response to therapy. Similar treatment responses were observed across different study populations. Conclusion(s): R-hFSH (combined with hCG) is effective for the restoration of fertility in the majority of men with HH. (Fertil Steril (R) 2009;92:594-604. (C)2009 by American Society for Reproductive Medicine.)