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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-24

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility (IVF Patients)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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fertile women

Reference group

No interventions assigned to this group

infertile women undergoing ART cycles

Cases group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Indication to ART
* Age 18-39 years
* First ART cycle
* Normal uterine morphology and no hydrosalpinx at ultrasound

* Subjects will be cycling women with proven fertility undergoing laparoscopy for tubal ligation
* BMI \< 30
* Aged 20 to 40 years