Study to Investigate the Treatment Benefit of Probiotic Lactobacillus Crispatus M247 in Women Undergoing Homologous Level 2 Assisted Reproductive Technology (ART) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pregnancy
研究概览
简要总结
The present study is aimed to explore the treatment effect from the intake of probiotic Lactobacillus crispatus M247 in the improvement of clinical and psychological aspects in women undergoing homologous level 2 ART procedures.
详细描述
The use of assisted reproductive technology (ART) has increased dramatically worldwide due to the continuous rise in infertility rates; for these reasons an increasing number of couples undertake the path of ART, even though this is difficult journey, with uncertain outcomes and possible medical risks, both physical and psychological.
In this study the investigators aim to explore the hypothesis that recreating a favorable vaginotype through the intake of the probiotic Lactobacillus crispatus M247 can have a positive effect in achieving pregnancy in cryopreserved cycles as well as a positive relationship between vaginal, endometrial (still unknown), gut and oral microbiota.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing homologous level 2 assisted reproductive technology (ART) procedures
- •Cryopreserved oocytes
- •D3 embryos
- •D5 blastulae
- •Age 18-45
排除标准
- •Presence of submucous uterine myomas.
- •Uterine malformations.
结局指标
主要结局
Pregnancy
时间窗: up to 12 months
Rate of pregnancy
次要结局
- Effect on sex hormonal profile(up to 12 months)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences