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

NCT02880280 | Unknown Phase 4

• 1 other identifier: BeijingChildrens-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kallmann Syndrome; Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• testicular volume

  Change from Baseline testicular volume at 3 months after treatment

Secondary Outcomes (1)

• The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys)

  Testosterone changes from 3 months onwards after treatment compared to pretreatment

Study Arms (2)

Human Menopausal Gonadotropin

EXPERIMENTAL

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

Drug: Human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin

Human Chorionic Gonadotropin

EXPERIMENTAL

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

Drug: Human Chorionic Gonadotropin

Interventions

Human Menopausal Gonadotropin DRUG

Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Also known as: Human Menopausal Gonadotropin(hMG)

Human Menopausal Gonadotropin

Human Chorionic Gonadotropin DRUG

Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Also known as: Human Chorionic Gonadotropin(hCG)

Human Chorionic Gonadotropin; Human Menopausal Gonadotropin

Eligibility Criteria

• Age: 138 Months - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33813517 DERIVED

MeSH Terms

Conditions

Kallmann Syndrome; Hypogonadism

Interventions

Menotropins; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures; Placental Hormones; Pregnancy Proteins; Proteins

Study Officials

• Chunxiu Gong, doctor

  Beijing Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Ying Liu, master

CONTACT

+8615001091953; judyjudy5479@aliyun.com

Chunxiu Gong, doctor

CONTACT

+8613370115001; chunxiugong@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 26, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)