Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogo… (NCT02880280) | Clinical Trial Compass
UnknownPhase 4
Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism
China40 participantsStarted 2016-08
Plain-language summary
Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.
Who can participate
Age range138 Months – 18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 eat…
What they're measuring
1
testicular volume
Timeframe: Change from Baseline testicular volume at 3 months after treatment