Idiopathic Hypogonadotropic Hypogonadism Clinical Trial
Official title:
Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
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.
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.) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Shanghai Jiao Tong University School of Medicine |
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 |
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