Clinical trial NCT02880280: Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kallmann Syndrome
Hypogonadotropic Hypogonadism
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 40
Sex: MALE
Minimum age (years): 138
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: testicular volume
timeFrame: Change from Baseline testicular volume at 3 months after treatment
Secondary outcomes:
measure: The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys)
timeFrame: Testosterone changes from 3 months onwards after treatment compared to pretreatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Chunxiu Gong, doctor
role: STUDY_DIRECTOR
References:
citation: Liu Y, Ren XY, Peng YG, Chen SK, Cheng XR, Qin M, Wang XL, Song YN, Fan LJ, Gong CX. Efficacy and safety of human chorionic gonadotropin combined with human menopausal gonadotropin and a gonadotropin-releasing hormone pump for male adolescents with congenital hypogonadotropic hypogonadism. Chin Med J (Engl). 2021 Mar 31;134(10):1152-1159. doi: 10.1097/CM9.0000000000001419.