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

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02310074
• Collaborator: (none)
• Enrollment: 76
• Arms: 2

Study Details

Study Description

Brief 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.

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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)

Outcome Measures

Primary Outcome Measures

1. pregnancy in the female partner [18 months]

Secondary Outcome Measures

1. first appearance of sperm (month after treatment) [18 months]

2. first time with sperm density>1*10^6/ml（month after treatment） [18 months]

3. first time with sperm density>15*10^6/ml（month after treatment） [18 months]

Other Outcome Measures

1. testicular volume [18 months]

2. prostatic volume [18 months]

3. Tanner stage for pubic hair [18 months]

4. Tanner stage for genital [18 months]

5. serum hormone levels [18 months]

   especially serum testosterone, LH, and FSH levels

6. sperm concentration per ejaculate [18 months]

7. adverse events [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

• Principal Investigator: Guang Ning, MD, PHD, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guang Ning, the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT02310074
• Other Study ID Numbers: ruijin-GnRH pump-002
• First Posted: Dec 5, 2014
• Last Update Posted: Feb 3, 2015
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Hypogonadism; Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone

Study Results

No Results Posted as of Feb 3, 2015