Sequential Therapy for Hypogonadotropic Hypogonadism
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2012-12
- Completion
- 2012-12
Outcome
Met primary endpoint
paper The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group (noninferiority, P = .008) by intention-to-treat analysis. PMID 25825944 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Follicle Stimulating Hormone | Protein / enzyme biologic | 75 iu | Intramuscular |
| Subject | Zinc gluconate | Small molecule | 20 mg | Oral |
| Comparator | human chorionic gonadotropin | Protein / enzyme biologic | 2000 iu | Intramuscular |