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临床试验/NCT06643065
NCT06643065招募中不适用

The Influence of the Vaginal Microbiome on Clinical Pregnancy in Patients Undergoing a Euploid Embryo Transfer: A Prospective Blinded Multicentre Cohort Study

Fundación IVI20 个研究点 分布在 1 个国家目标入组 1,573 人开始时间: 2024年7月17日最近更新:
适应症

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

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

研究者

发起方
Fundación IVI
申办方类型
Other
责任方
Sponsor

研究点 (20)

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