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Sequential Therapy for Hypogonadotropic Hypogonadism

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01403532
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
39
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Traditional intervention for HH using HCG and FSH
  • Drug: Sequential intervention for HH using HCG and FSH
  • Drug: Sequential intervention for HH using HCG and FSH plus zinc
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Traditional

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;
Other Names:
  • Tranditional

    		•
    Experimental: Sequential

    Drug: 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
    Other Names:
  • Sequential

    		•
    Experimental: Sequential Plus

    Drug: 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
    Other Names:
  • Sequential plus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sperm density ≥1,000,000/ml [One and a half year]

      The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • Principal Investigator: Xiao-Ying Li, MD,PhD, Shanghai Jiao Tong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao-Ying Li, Professor, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01403532
    Other Study ID Numbers:
    • CCEMD005
    First Posted:
    Jul 27, 2011
    Last Update Posted:
    Feb 11, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Xiao-Ying Li, Professor, Shanghai Jiao Tong University School of Medicine
    Hypogonadotropic Hypogonadism
    Kallmann Syndrome
    LH
    FSH
    Additional relevant MeSH terms:
    Kallmann Syndrome
    Hypogonadism

    Study Results

    No Results Posted as of Feb 11, 2014