The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: A Prospective Blinded Multicentre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,573
- 试验地点
- 20
- 主要终点
- microbial DNA extraction using molecular techniques such as qPCR
研究概览
简要总结
Microorganisms such as bacteria live naturally on and in the bodies and are of great importance for our health. In the female body, almost 10% of all microorganisms live in the reproductive organs and especially in the vagina. Healthy bacteria in the vagina can defend against harmful bacteria and infections. However, it occasionally happens that the balance between healthy and harmful bacteria is disturbed, and it is believed that this could potentially harm pregnancy. However, there is not much evidence to prove a connection between an imbalance in bacteria and having an unsuccessful pregnancy.
For this reason, the goal of our study is to determine if women with certain vaginal bacteria are more likely to experience pregnancy failures. If the investigators find this to be true, patients undergoing fertility treatment might be recommended regular tests in the future. If an imbalance in bacteria is found, doctors could provide treatment to restore a healthy vaginal environment, potentially improving the chances of a successful pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ART patients undergoing the transfer of a euploid embryo
排除标准
- •Patients with a body mass index (BMI) ≥35
- •Patients with uncorrected uterine malformations
- •Patients with a unicornuate uterus
- •Patients with a bicornuate uterus
- •Patients with any type of submucosal myoma
- •Patients with an intramural myoma if ≥4 cm
- •Patients with severe adenomyosis (>50% of the uterine corpus affected as defined by the MUSA criteria [19])
- •Patients undergoing transfer of an embryo with a morphology score <4BC (according to the Gardner & Schoolcraft scoring system [18])
- •Patients undergoing transfer of a day-7 embryo
- •Patients who took antibiotics in the month prior to the embryo transfer (excluding antibiotics given following oocyte retrieval)
研究组 & 干预措施
Group-1
normal microbiome
Group-2
dysbiotic microbiome
结局指标
主要结局
microbial DNA extraction using molecular techniques such as qPCR
时间窗: day of embryo transfer (between days 18 and 21 of the menstrual cycle)
microbial composition. Detection (i.e., presence or absence) of the targeted bacteria and their quantification (i.e., the relative amount of each bacterial species present in the sample).
次要结局
未报告次要终点
