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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism

Treatments: Drug: Human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT02880280

BeijingChildrens-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 138 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Human Menopausal Gonadotropin

Experimental group

Description:

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

Treatment:

Drug: Human Chorionic Gonadotropin

Drug: Human Menopausal Gonadotropin

Human Chorionic Gonadotropin

Experimental group

Description:

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

Treatment:

Drug: Human Chorionic Gonadotropin