Sequential Therapy for Hypogonadotropic Hypogonadism

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones

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