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Sequential Therapy for Hypogonadotropic Hypogonadism

Primary Purpose

Hypogonadotropic Hypogonadism, Kallmann Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Traditional intervention for HH using HCG and FSH
Sequential intervention for HH using HCG and FSH
Sequential intervention for HH using HCG and FSH plus zinc
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH

Eligibility Criteria

16 Years - 45 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Traditional

Sequential

Sequential Plus

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2011
Last Updated
February 10, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01403532
Brief Title
Sequential Therapy for Hypogonadotropic Hypogonadism
Official Title
Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism, Kallmann Syndrome
Keywords
Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional
Arm Type
Active Comparator
Arm Title
Sequential
Arm Type
Experimental
Arm Title
Sequential Plus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Traditional intervention for HH using HCG and FSH
Other Intervention Name(s)
Tranditional
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Sequential intervention for HH using HCG and FSH
Other Intervention Name(s)
Sequential
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sequential intervention for HH using HCG and FSH plus zinc
Other Intervention Name(s)
Sequential plus
Intervention Description
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
Primary Outcome Measure Information:
Title
Sperm density ≥1,000,000/ml
Description
The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.
Time Frame
One and a half year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Ying Li, MD,PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25825944
Citation
Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.
Results Reference
derived

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Sequential Therapy for Hypogonadotropic Hypogonadism

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