Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Implantation rate
研究概览
简要总结
This study is the first to evaluate the effect of oral supplementation with antioxidants combined with lifestyle modification for severe male factor partner of couples undergoing ICSI.
详细描述
Patients underwent a therapy of a three-month period of treatment with either oral L-carnitine only (2g daily) or oral carnitine (2g daily) combined with modifiable lifestyle factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Long protocol for ovulation
- •Oligoasthenoteratozoospermic male partner ( (count < 0.5 million/ml, Motility=< 40% Progressive motility =<10 %, Abnormal forms >99%).
- •Fresh semen samples.
排除标准
- •Day 3 embryo transfer
- •Incomplete ICSI cycles
- •Endometrial thickness> 7mm
研究组 & 干预措施
Antioxidant group
In the control group, all patients will go a double-blind therapy of a three-months period of treatment with oral carnitine (2g daily). After this period, all patients will undergo conventional intacytoplasmic sperm injection (ICSI).
Antioxidant+modifiable lifestyle factors
In the study group, all patients underwent a double-blind therapy of a six-month period of treatment with oral carnitine (2g daily) combined with modifiable lifestyle factors. Patients were requested to follow a healthy standard diet, avoid excessive heat exposure, avoid or minimize exposure to pollutants, and stop smoking, coffee, alcohol, and drugs uptake.After this period, all patients will undergo conventional ICSI.
干预措施: Antioxidant (l-cratinine) + modifiable lifestyle factors (Other)
结局指标
主要结局
Implantation rate
时间窗: one month
Clinical pregnancy rate
时间窗: two weeks
次要结局
未报告次要终点
研究者
Salah Elbashir
Assisting lecturer of Urology
Benha University