Sequential Therapy for Hypogonadotropic Hypogonadism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypogonadotropic Hypogonadism Kallmann Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional

Group Type ACTIVE_COMPARATOR

Traditional intervention for HH using HCG and FSH

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Sequential intervention for HH using HCG and FSH

Intervention Type DRUG

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 Plus

Group Type EXPERIMENTAL

Sequential intervention for HH using HCG and FSH plus zinc

Intervention Type DRUG

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

Interventions

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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;

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Tranditional Sequential Sequential plus

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No