Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
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|ClinicalTrials.gov Identifier: NCT02310074|
Recruitment Status : Unknown
Verified December 2014 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Active, not recruiting
First Posted : December 5, 2014
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Hypogonadotropic Hypogonadism||Drug: Pulsatile Gonadotropin Releasing Hormone Drug: Human chorionic gonadotropin Drug: Urinary Follicle-Stimulating Hormone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2014|
Experimental: Pulsatile Gonadotropin Releasing Hormone
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.
Drug: Pulsatile Gonadotropin Releasing Hormone
Other Name: Pulsatile GnRH pump
Active Comparator: combination gonadotropin therapy
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
Drug: Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
Drug: Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)
- pregnancy in the female partner [ Time Frame: 18 months ]
- 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 ]
- testicular volume [ Time Frame: 18 months ]
- prostatic volume [ Time Frame: 18 months ]
- Tanner stage for pubic hair [ Time Frame: 18 months ]
- Tanner stage for genital [ Time Frame: 18 months ]
- serum hormone levels [ Time Frame: 18 months ]especially serum testosterone, LH, and FSH levels
- sperm concentration per ejaculate [ Time Frame: 18 months ]
- adverse events [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310074
|Principal Investigator:||Guang Ning, MD, PHD||Shanghai Jiao Tong University School of Medicine|