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NCT07085585

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

Active, enrolled Last updated 25 July 2025
What this trial tests

trial in Infertility (IVF Patients) in 322 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
24 January 2021
Primary endpoint
31 October 2025
30 November 2025

Quick facts

Lead sponsorIRCCS San Raffaele
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment322
Start date24 January 2021
Primary completion31 October 2025
Estimated completion30 November 2025
Sites1 location across Italy

Conditions studied

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

Adults 18 to 40, female only, with Infertility (IVF Patients). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Infertility (IVF Patients)

Currently open trials in the same condition.

Other IRCCS San Raffaele trials

Trials by the same sponsor.

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Data sources for this page

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