Observe the therapeutic efficacy of human menopausal gonadotropin combining with human
chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.
Drug: Human Menopausal Gonadotropin
Drug: Human Chorionic Gonadotropin
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Full eligibility criteria for NCT02880280
Ages eligible for Study
138 Months to 18 Years
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria Criteria A
Boy >14yr without any sign of puberty, testis <4ml
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.
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
Eating disorder (such as anorexia nervosa, binge eating)
Any brain diseases history: tumors in brain or pituitary or after their surgeries
All locations for NCT02880280
Beijing Children's Hospital
Beijing, Beijing, China, 100045
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Tris trial is registered with FDA with number: NCT02880280. The sponsor of the trial is Beijing Children's Hospital and it is looking for 40 volunteers for the current phase.
Official trial title: Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism
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