Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism

Study Overview
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Brief Summary
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Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.

Detailed Description
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Observe safety and efficacy of human menopausal gonadotropin and human chorionic gonadotropin treating congenital hypogonadotropic hypogonadism in teenagers; which as clinic recommendation, may provide clinical basis for establishing standard treatment guideline in the future. Establish technological process and follow-up precept for human menopausal gonadotropin and human chorionic gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers. And find safety and effective dose for teenagers.

Official Title
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Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism

Conditions
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Kallmann Syndrome, Hypogonadotropic Hypogonadism

Intervention / Treatment
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* Drug: Human Menopausal Gonadotropin
* Drug: Human Chorionic Gonadotropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Criteria A Boy >14yr without any sign of puberty, testis <4ml BA ≥12yr Sex hormone (LH,FSH, T) are pre-pubertal level No other hormones problems (other pituitary glands axis are normal except gonad axis) No space occupying lesion, No tumor on MRI of pituitary and hypothalamus area Kallmann's syndrome(KS) patients may companies with dysosmia or dysplasia of olfactory bulb or olfactory tract on MRI Karyotype is 46，XY Exclude chronic diseases, malnutrition Criteria B For the boy <14yr. who companies with micropenis or cryptorchid or hypospadias and they have anosmia or dysplasia of olfactory bulb/olfactory sulcus/olfactory structs on MRI include in. Criteria C As the phenotype of hypogonadotropic hypogonadism are variant, some of them may have partial puberty. So, we enrolled them when they have testis volume >4ml or the testosterone level >200ng/L，companies anosmia or dysplasia of olfactory bulb /olfactory sulcus/ olfactory structs on MRI, and the puberty arrested in half a year. These patients can be diagnosed as Kallmann Syndrome. Exclusion Criteria: Any ascertain reason contributes to the non puberty development (Chromosome abnormal, trauma, surgeries) or any ascertain disease such as Prader-Willi syndrome or hypergonadotropic hypogonadism Systemic diseases (such as chronic kidney failure, Mediterranean anemia, poor controlled diabetes) Protein-energy malnutrition Eating disorder (such as anorexia nervosa, binge eating) Any brain diseases history: tumors in brain or pituitary or after their surgeries

Ages Eligible for Study
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Minimum Age: 138 Months
Maximum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Menopausal Gonadotropin<br>Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH) | Drug: Human Menopausal Gonadotropin<br>* Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers<br>* Other names: Human Menopausal Gonadotropin(hMG);Drug: Human Chorionic Gonadotropin<br>* Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers<br>* Other names: Human Chorionic Gonadotropin(hCG);|
| Experimental: Human Chorionic Gonadotropin<br>Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation | Drug: Human Chorionic Gonadotropin<br>* Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers<br>* Other names: Human Chorionic Gonadotropin(hCG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| testicular volume |  | Change from Baseline testicular volume at 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys) |  | Testosterone changes from 3 months onwards after treatment compared to pretreatment |