Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sperm density ≥1,000,000/ml
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Traditional
干预措施: Traditional intervention for HH using HCG and FSH (Drug)
Sequential
干预措施: Sequential intervention for HH using HCG and FSH (Drug)
Sequential Plus
干预措施: Sequential intervention for HH using HCG and FSH plus zinc (Drug)
结局指标
主要结局
Sperm density ≥1,000,000/ml
时间窗: One and a half year
The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.
次要结局
未报告次要终点
研究者
Xiao-Ying Li
Professor
Shanghai Jiao Tong University School of Medicine