Modulating the Vaginal Microbiome After Implantation Failure A Randomized Placebo Controlled Study of Vaginal Lactobacilli Supplements
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in vaginal microbiome after intervention
研究概览
简要总结
Vaginal microbiome has in studies shown a link with the outcome of fertility treatment. The investigators wish to determine if it is possible to change an unfavorable vaginal microbiome using lactobacilli loaded vaginal supplements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigator, care providers and outcome assessors are all blinded until the end of inclusion af the last subject.
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •unfavorable vaginal microbiome using ARTPreds test
- •non-smoker
排除标准
- •use of oral antibiotics oral probiotics between diagnosis and inclusion in the study
- •pregnancy at inclusion
- •allergy towards study drugs
研究组 & 干预措施
Vivag Plus
Vivag Plus vaginal supplements one capsule every night for ten days start cycle day 6-7.
干预措施: Vivag Plus (Drug)
Placebo
Placebo vaginal supplements one capsule every night for ten days start cycle day 6-7.
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Change in vaginal microbiome after intervention
时间窗: 2 months
The investigators wish to determine if the vaginal microbiome will stay changed one month after intervention. The change in vaginal microbiome will be measured with ARTPreds diagnostic test, after intervention and again one month later. The test divides the vaginal microbiome into three categories, low, medium and high. A change in vaginal microbiome is defined by a shift from low to medium or high, or a shift from medium to high.
次要结局
未报告次要终点
研究者
Nicholas Macklon
Professor
Zealand University Hospital