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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01403532
Other study ID # CCEMD005
Secondary ID
Status Completed
Phase Phase 4
First received February 1, 2011
Last updated February 10, 2014
Start date September 2009
Est. completion date December 2012

Study information

Verified date February 2014
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Male
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria:

- Clinical hypogonadotropic hypogonadism

- Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL

- Infantile testis

- Delayed bone age

- Normal testing of the anterior pituitary gland

Exclusion Criteria:

- Prior therapy with HMG or FSH

- Severe dysfunction of live and kidney

- Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation)

- Another pituitary hormonal deficiency

- Hypergonadotropic hypogonadism

- With abnormal karyotype

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Traditional intervention for HH using HCG and FSH
Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;
Sequential intervention for HH using HCG and FSH
Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months
Sequential intervention for HH using HCG and FSH plus zinc
Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily

Locations

Country Name City State
China Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm density =1,000,000/ml The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject. One and a half year Yes
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