Zhang M, Tong G, Liu Y, Mu Y, Weng J, et al. Sequential versus Continual Purified Urinary FSH / hCG in Men with Idiopathic Hypogonadotropic Hypogonadism. The Journal of Clinical Endocrinology & Metabolism. http://press.endocrine.org/doi/abs/10.1210/jc.2014-3802
Context: Gonadotropin therapy using a human chorionic gonadotropin (hCG) and follicle-stimulating hormone (FSH) preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism (IHH). However, the high cost of medication and frequent injections affect compliance.
Objective: This study aims to determine the efficacy of sequential use of highly purified urinary FSH (uFSH)/hCG in men with IHH.
Design and Setting: A randomized, open-label, prospective, controlled non-inferiority trial with 18 month follow-up was conducted in 9 tertiary hospitals.
Patients and Intervention: 67 Chinese males with IHH were randomly allocated into Group A receiving continual uFSH (75 U, three times a week) and hCG ( 2000 U, twice a week) injection and Group B receiving sequential uFSH (75 U, three times a week every other three months) and hCG (2000 U, twice a week) injection.
Main Outcome Measure: The primary outcome was the proportion of subjects with a sperm concentration ≥ 1.0 × 106/ml during the 18 months. Comparison of efficacy between Groups A and B was analyzed for non-inferiority.
Results: 17/33 (51.5%) of patients receiving continual uFSH/hCG and 19/34 (55.9%) of patients receiving sequential uFSH/hCG achieved sperm concentration ≥ 1.0 × 106/ml. Efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (non-inferiority, p=0.008) by intention to treat analysis.
Conclusions: The efficacy of sequential uFSH/hCG regimen is not inferior to that of continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of IHH patients.
Context: Gonadotropin therapy using a human chorionic gonadotropin (hCG) and follicle-stimulating hormone (FSH) preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism (IHH). However, the high cost of medication and frequent injections affect compliance.
Objective: This study aims to determine the efficacy of sequential use of highly purified urinary FSH (uFSH)/hCG in men with IHH.
Design and Setting: A randomized, open-label, prospective, controlled non-inferiority trial with 18 month follow-up was conducted in 9 tertiary hospitals.
Patients and Intervention: 67 Chinese males with IHH were randomly allocated into Group A receiving continual uFSH (75 U, three times a week) and hCG ( 2000 U, twice a week) injection and Group B receiving sequential uFSH (75 U, three times a week every other three months) and hCG (2000 U, twice a week) injection.
Main Outcome Measure: The primary outcome was the proportion of subjects with a sperm concentration ≥ 1.0 × 106/ml during the 18 months. Comparison of efficacy between Groups A and B was analyzed for non-inferiority.
Results: 17/33 (51.5%) of patients receiving continual uFSH/hCG and 19/34 (55.9%) of patients receiving sequential uFSH/hCG achieved sperm concentration ≥ 1.0 × 106/ml. Efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (non-inferiority, p=0.008) by intention to treat analysis.
Conclusions: The efficacy of sequential uFSH/hCG regimen is not inferior to that of continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of IHH patients.
