The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in sperm motility at 12 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:
- Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?
- What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.
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
- Single (Participant)
盲法说明
Placebo
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Infertile men
- •Idiopathic oligoasthenozoospermia (serum FSH and serum LH range was 2-7 IU/mL and serum testosterone level was >300 ng/dl)
排除标准
- •Azoospermia
- •Body mass index <18 kg/m2 and >30 kg/m2
- •Any abnormality on genital examination and scrotal sonogram
- •History of genital diseases & genital surgery
- •Medical and endocrine disorders like uncontrolled diabetes mellitus, severe kidney disease and liver insufficiency
- •Psycho-sexual abnormalities
- •Antioxidant supplements in previous 3 months
- •Smoking, drug, alcohol or substance abuse
- •History of chemotherapy or radiotherapy
- •Presence of any gross female factor abnormality
研究组 & 干预措施
Clomiphene
Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks
干预措施: Clomiphene Citrate (Drug)
Placebo
Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in sperm motility at 12 weeks
时间窗: Baseline and 12 weeks
Sperm motility was percentage of progressive \& non-progressive motility
Change from baseline in sperm count at 12 weeks
时间窗: Baseline and 12 weeks
Sperm count was in million per milliliter of semen
次要结局
未报告次要终点
研究者
Shakeela Ishrat
Professor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh