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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

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.

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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.

Conditions

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Kallmann Syndrome Hypogonadotropic Hypogonadism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human Menopausal Gonadotropin

Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)

Group Type EXPERIMENTAL

Human Menopausal Gonadotropin

Intervention Type DRUG

Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Human Chorionic Gonadotropin

Intervention Type DRUG

Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Human Chorionic Gonadotropin

Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation

Group Type EXPERIMENTAL

Human Chorionic Gonadotropin

Intervention Type DRUG

Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Interventions

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Human Menopausal Gonadotropin

Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Intervention Type DRUG

Human Chorionic Gonadotropin

Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Intervention Type DRUG

Other Intervention Names

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Human Menopausal Gonadotropin(hMG) Human Chorionic Gonadotropin(hCG)

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

Minimum Eligible Age

138 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No