Sequential Therapy for Hypogonadotropic Hypogonadism

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism

Conditions
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Hypogonadotropic Hypogonadism, Kallmann Syndrome

Intervention / Treatment
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* Drug: Traditional intervention for HH using HCG and FSH
* Drug: Sequential intervention for HH using HCG and FSH
* Drug: Sequential intervention for HH using HCG and FSH plus zinc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional<br> | Drug: Traditional intervention for HH using HCG and FSH<br>* Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;<br>* Other names: Tranditional;|
| Experimental: Sequential<br> | Drug: Sequential intervention for HH using HCG and FSH<br>* Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months<br>* Other names: Sequential;|
| Experimental: Sequential Plus<br> | Drug: Sequential intervention for HH using HCG and FSH plus zinc<br>* Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily<br>* Other names: Sequential plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LH, Hypogonadotropic Hypogonadism, Kallmann Syndrome, FSH