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
About this trial
This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring Hypogonadotropic Hypogonadism, Kallmann Syndrome, LH, FSH
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
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
NCT ID
NCT01403532
First Posted
February 1, 2011
Last Updated
February 10, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
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
Learn more about this trial
Sequential Therapy for Hypogonadotropic Hypogonadism
We'll reach out to this number within 24 hrs