Sequential Therapy for Hypogonadotropic Hypogonadism

Phase 4

Completed

• Conditions: Hypogonadotropic Hypogonadism; Kallmann Syndrome
• Interventions: 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

• Registration Number: NCT01403532
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	Traditional intervention for HH using HCG and FSH	-
Sequential	Sequential intervention for HH using HCG and FSH	-
Sequential Plus	Sequential intervention for HH using HCG and FSH plus zinc	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China