Overview

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

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
Male
Summary
Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Children's Hospital
Treatments:
Chorionic Gonadotropin
Menotropins
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