Back to results

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

Primary Purpose

Kallmann Syndrome, Hypogonadotropic Hypogonadism

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Human Menopausal Gonadotropin

Human Chorionic Gonadotropin

About this trial

This is an interventional treatment trial for Kallmann Syndrome

Eligibility Criteria

138 Months - 18 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Beijing Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Human Menopausal Gonadotropin

Human Chorionic Gonadotropin

Arm Description

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

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

Outcomes

Primary Outcome Measures

testicular volume

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02880280

First Posted

August 11, 2016

Last Updated

August 25, 2016

Sponsor

Beijing Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02880280

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kallmann Syndrome, Hypogonadotropic Hypogonadism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Human Menopausal Gonadotropin

Arm Type

Experimental

Arm Description

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

Arm Title

Human Chorionic Gonadotropin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Human Menopausal Gonadotropin

Other Intervention Name(s)

Human Menopausal Gonadotropin(hMG)

Intervention Description

Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Intervention Type

Drug

Intervention Name(s)

Human Chorionic Gonadotropin

Other Intervention Name(s)

Human Chorionic Gonadotropin(hCG)

Intervention Description

Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Primary Outcome Measure Information:

Title

testicular volume

Time Frame

Change from Baseline testicular volume at 3 months after treatment

Secondary Outcome Measure Information:

Title

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

Time Frame

Testosterone changes from 3 months onwards after treatment compared to pretreatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

138 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Liu, master

Phone

+8615001091953

judyjudy5479@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chunxiu Gong, doctor

Phone

+8613370115001

chunxiugong@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunxiu Gong, doctor

Organizational Affiliation

Beijing Children's Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Children's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100045

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ying Liu, master

Phone

+8615001091953

judyjudy5479@aliyun.com

First Name & Middle Initial & Last Name & Degree

Chunxiu Gong, doctor

Phone

+8613370115001

chunxiugong@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33813517

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs