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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02310074
Other study ID # ruijin-GnRH pump-002
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received December 3, 2014
Last updated January 31, 2015
Start date January 2010

Study information

Verified date December 2014
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 76
Est. completion date
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Male
Age group 16 Years to 35 Years
Eligibility 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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Pulsatile Gonadotropin Releasing Hormone

Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Other testicular volume 18 months No
Other prostatic volume 18 months No
Other Tanner stage for pubic hair 18 months No
Other Tanner stage for genital 18 months No
Other serum hormone levels especially serum testosterone, LH, and FSH levels 18 months No
Other sperm concentration per ejaculate 18 months No
Other adverse events 18 months Yes
Primary pregnancy in the female partner 18 months No
Secondary first appearance of sperm (month after treatment) 18 months No
Secondary first time with sperm density>1*10^6/ml(month after treatment) 18 months No
Secondary first time with sperm density>15*10^6/ml(month after treatment) 18 months No
See also
  Status Clinical Trial Phase
Completed NCT02728440 - Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism N/A
Terminated NCT01165619 - Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders N/A
Completed NCT01914172 - Health Needs of Patients With Kallmann Syndrome N/A
Completed NCT02042638 - The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism N/A
Completed NCT01601327 - Effects of Medications in Patients With Hypogonadism Phase 4
Completed NCT01758094 - Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism N/A
Completed NCT00493961 - Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism Phase 1
Recruiting NCT05569577 - An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients N/A