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J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.

Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism.

Author information

1
Shanghai Institute of Endocrinology and Metabolism (M.Z., Y.L., S.S., G.N., X.L.), Department of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 201101; Department of Endocrinology (G.T., H.H., D.Z.), Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China 210029; Department of Endocrinology (Y.M., Q.G., Y.G.), General Hospital of Chinese People's Liberation Army, Beijing, China 100037; Department of Endocrinology (J.W., Y.Z.), The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China 510630; Department of Endocrinology and Metabolism (Ya.X., Y.C.), Nanfang Hospital, Southern Medical University, Guangzhou, China 510515; Department of Endocrinology (Z.Luo, J.Z.), Guangxi Medical University and First Affiliated Hospital, Guangxi, China 530027; Department of Endocrinology (Yu.X., B.N.), The First People's Hospital of Yunnan Province, Yunnan, China 650091; Department of Endocrinology (L.S., H.L.), The Affiliated Hospital of Guiyang Medical College, Guizhou, China 550004; Department of Endocrinology (X.W.), Peking Union Medical College Hospital, Peking Union Medical College, Beijing, China 100730; and Epidemiology Research Unit (Z.Li), The First Affiliated Hospital, Xiamen University, Xiamen, China 361003.

Abstract

CONTEXT:

Gonadotropin therapy using a human chorionic gonadotropin (hCG) and 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:

The aim of this study was 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 noninferiority trial with an 18-month follow-up was conducted in 9 tertiary hospitals.

PATIENTS AND INTERVENTION:

A total of 67 Chinese men with IHH were randomly allocated into group A receiving continual uFSH (75 U, 3 times a week) and hCG (2000 U, twice a week) injection and group B receiving sequential uFSH (75 U, 3 times a week every other 3 months) and hCG (2000 U, twice a week) injection.

MAIN OUTCOME MEASURE:

The primary outcome was the proportion of subjects with a sperm concentration of ≥ 1.0 × 10(6)/mL during the 18 months. The efficacy between groups A and B was compared for noninferiority.

RESULTS:

Of the patients, 17/33 (51.5%) receiving continual uFSH/hCG and 19/34 (55.9%) receiving sequential uFSH/hCG achieved sperm concentrations of ≥ 1.0 × 10(6)/mL. The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (noninferiority, P = .008) by intention-to-treat analysis.

CONCLUSIONS:

The efficacy of the sequential uFSH/hCG regimen is not inferior to that of the continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of patients with IHH.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01403532.

PMID:
25825944
DOI:
10.1210/jc.2014-3802
[Indexed for MEDLINE]

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