NCT02310074

Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Male
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.

Detailed description

Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH. The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration\>0\*10\^6/ml , \>1.0 \*10\^6/ml and \>15 \*10\^6/ml, respectively. The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels \[especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels\], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.

Conditions

• Idiopathic Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	Pulsatile Gonadotropin Releasing Hormone
DRUG	Human chorionic gonadotropin	Human chorionic gonadotropin (hCG)
DRUG	Urinary Follicle-Stimulating Hormone	Urinary Follicle-Stimulating Hormone (uFSH)

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-06-01
• First posted: 2014-12-05
• Last updated: 2015-02-03