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 × 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 × 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.