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临床试验/NCT07085585
NCT07085585进行中(未招募)不适用

The Embryo-endometrium Multifaceted Interface: Endometrial Cavity Molecular Microbiobial and Transcriptomic Signatures in Predictinf Pregnancy Outcome in Infertile Patients Undergoing Assisted Reproduction Technology Procedures

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2021年1月24日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
322
试验地点
1
主要终点
Identification of endometrial microbiome diversity

研究概览

简要总结

In reproductive medicine, a fundamental challenge is to evaluate the endometrial health status during the embryo implantation window as a limiting step in predicting the success of treatments of assisted reproduction technology (ART). Some highthroughput tools, recently developed by private genomics companies, are available in the market even if they have not been independently validated and have different limitations. We propose a prospective cohort study with the aim of validating the reliability and increasing efficacy of these tools. Endometrial fluid samples will be collected non-invasively from women undergoing ART cycles and isolated genetic materials will be subjected to 16S rRNA gene sequencing for microbiota profiling and to RNAseq analysis of RNA content of extracellular vesicles previously recognized as a tissue proxy in predicting endometrial receptivity. Clinical pregnancy rate/first cycle will be the target outcome used to assess the resulting predictive models. Ultrasonographic features of the endometrium will also be collected and accounted for in the predictive model.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Identification of endometrial microbiome diversity

时间窗: through study completion, an average of 1 year

Evaluation of the endometrial microbiome composition and diversity using 16S rRNA sequencing to assess the functional impact of the endometrial microbial community in predicting the clinical pregnancy rate in women undergoing ART cycles.

Extracellular Vesicle (EV) RNA Profiles

时间窗: through study completion, an average of 1 year

Quantification of extracellular vesicle (EV) RNA expression profiles from uterine fluid samples using RNA sequencing (expressed in CPM). Confirmation of the good correlation between expression of genes in tissue samples and in endometrial-derived EVs.

Integrated Predictive Model for Clinical Pregnancy

时间窗: through study completion, an average of 1 year

Development of a multivariable predictive model combining endometrial microbiome diversity, EV RNA profiles, and ultrasound-AI analysis to predict clinical pregnancy rates in ART cycles.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rovere Querini Patrizia

MD, PhD

IRCCS San Raffaele

研究点 (1)

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