Impact of Probiotic supplementation on endometrial microbiome in unexplained infertility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of woman with lactobacillus crispatus dominant endometrium versus non-dominant endometrium before and after 3 months of probiotic/placebo supplementation
研究概览
简要总结
Rationale
Unexplained infertility, accounting for nearly 15-30% of infertility cases, lacks an identifiable cause despite normal routine investigations. Emerging evidence highlights the role of the endometrial microbiome, particularly the predominance of Lactobacillus crispatus, in successful implantation and pregnancy. Dysbiosis, characterized by a reduction in Lactobacillus dominance, is associated with poor reproductive outcomes. Probiotic supplementation, especially oral probiotics containing L. crispatus, has shown promise in restoring microbial balance and potentially improving pregnancy outcomes. However, research evaluating its direct impact on the endometrial microbiome in unexplained infertility remains limited. This study aims to bridge that gap by investigating whether probiotic supplementation can favourably modify the endometrial microbial environment and enhance fertility outcomes.
The Mechanism of Action - Orally administered probiotics (Lactobacillus crispatus) migrate from intestine to the anus and finally to the vagina. This mechanism seems to combine mucosa-adhesive features of Lactobacilli and chemotactic factors that guide their migration towards the vaginal mucosa (Reid, 2008; Borges et al, 2014).
Orally consumed probiotics have shown beneficial effects in studies investigating Bacterial Vaginosis (reduced U gent score) and Bacterial Vaginosis associated symptoms in comparison to both placebo and conventional antibiotic treatment and prolonged remission in recurrent BV as adjunct to conventional antibiotic therapy. Vaginal colonization by orally consumed probiotics has been reported both with strain-leve detection and as elevation of the supplemented species. Commensal bacterial in vagina represents one of the first lines of defence against vaginal infection. Lactobacillus crispatus play important roles in this defence, thus regulating the vaginal immune system. In the vaginal tract probiotics are considered to promote antimicrobial activity by reducing vaginal pay via lactic acid production, producing bacteriocins
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Women with normal ovulating cycles, normal uterine cavity, and at least unilateral patent tube Men with normal HSA.
排除标准
- •Couples with HIV hepatitis B, hepatitis and hepatitis C Woman with PID Couples with systemic disease like diabetes, hypertension and tuberculosis.
结局指标
主要结局
The proportion of woman with lactobacillus crispatus dominant endometrium versus non-dominant endometrium before and after 3 months of probiotic/placebo supplementation
时间窗: The proportion of woman with lactobacillus crispatus dominant endometrium versus non-dominant endometrium before and after 3 months of probiotic/placebo supplementation
次要结局
- 1. The number of women with positive UPT after a missed period in each group(2. Number of women with confirmed card activity 6 to 7 weeks of gestation in each group.)
研究者
Aashima Atrey
Guru teg Bahadur hospital Dilshad garden, shahdara Delhi