Hypogonadotropic Hypogonadism Clinical Trial
Official title:
Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Clinical hypogonadotropic hypogonadism - Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL - Infantile testis - Delayed bone age - Normal testing of the anterior pituitary gland Exclusion Criteria: - Prior therapy with HMG or FSH - Severe dysfunction of live and kidney - Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation) - Another pituitary hormonal deficiency - Hypergonadotropic hypogonadism - With abnormal karyotype |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sperm density =1,000,000/ml | The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject. | One and a half year | Yes |
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