Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- sperm count
研究概览
简要总结
Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.
详细描述
Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •oligospermia ( < 10 million per mil-litter )
- •normal FSH
- •high insulin
排除标准
- •abnormal karyotype
- •obstructive azoospermia
研究组 & 干预措施
Metformin / clomid / hCG
Metformin 1000 mg orally to be given daily for one week then twice daily for 2 weeks then 3 times daily for 6 months.
After 3 months from starting metformin the participant will receive 2 more medications in addition to metformin:
Clomid 50 mg orally per day and 5000 IU human chorionic gonadotrophin (hCG ) IM once per week for three months.
干预措施: Metformin / clomid / hCG (Drug)
Clomid / hCG
Clomid 50 mg per day will be administered orally and human chorionic gonadotrophin ( choriomon ) 5000 IU will be administered IM once per week. Both medications will be given for 6 month.
干预措施: Clomiphene citrate / hCG (Drug)
结局指标
主要结局
sperm count
时间窗: 6 months
semen analysis before the start of metformin and then every month for 6 months
次要结局
- abnormal forms of spermatozoa(6 months)
研究者
Ragaa Mansour
Director
The Egyptian IVF-ET Center