Overview

This trial is active, not recruiting.

Condition idiopathic hypogonadotropic hypogonadism
Treatments pulsatile gonadotropin releasing hormone, human chorionic gonadotropin, urinary follicle-stimulating hormone
Phase phase 4
Sponsor Shanghai Jiao Tong University School of Medicine
Start date January 2010
End date June 2014
Trial size 76 participants
Trial identifier NCT02310074, ruijin-GnRH pump-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.
pulsatile gonadotropin releasing hormone Pulsatile GnRH pump
(Active Comparator)
combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months
human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
urinary follicle-stimulating hormone
Urinary Follicle-Stimulating Hormone (uFSH)

Primary Outcomes

Measure
pregnancy in the female partner
time frame: 18 months

Secondary Outcomes

Measure
first appearance of sperm (month after treatment)
time frame: 18 months
first time with sperm density>1*10^6/ml(month after treatment)
time frame: 18 months
first time with sperm density>15*10^6/ml(month after treatment)
time frame: 18 months

Eligibility Criteria

Male participants from 16 years up to 35 years old.

Inclusion Criteria: 1. Age greater than 16 yr 2. Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism 3. Hypogonadal serum testosterone levels (<166ng/dl) in the presence of low or normal gonadotropins 4. Normal levels of other anterior pituitary hormones 5. Normal MRI scans of the hypothalamo-pituitary region 6. Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment Exclusion Criteria: 1. With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study 2. Congenital hypopituitarism 3. Any medical or surgical conditions possibly affecting the experiment result 4. Any clinically significant allergic diseases or allergic to the study drugs 5. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)

Additional Information

Official title Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Principal investigator Guang Ning, MD, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.