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NCT03330444 · ClinicalTrials.gov registry record

Development of a Microbiome Non-invasive Diagnosis Tool

A clinical trial, sponsored by Igenomix.

Completed
Registry status
452
Enrollment target

NCT03330444 is a clinical trial that has completed, run by Igenomix. The registered enrollment target is 452 participants.

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The verdict

NCT03330444 has completed, sponsored by Igenomix.

COMPLETED
Registry status
452 participants
Enrollment target

Study Summary

Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously published studies, in normal conditions the endometrium is mainly composed of different species of the genus Lactobacillus. It was further noted that the presence of other pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial microbiome and can disrupt the uterine environment, affecting implantation rates and pregnancy success. This project aims to validate the microbiome found in the endometrium of women of reproductive age and try to corroborate the relationship between the endometrial microbiome and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART). The use of Endometrial Receptivity Analysis (ERA) tool, together with the analysis of the endometrial flora before the embryo transfer will allow to evaluate the impact of the presence of endometrial pathogens on implantation in receptive patients. Therefore, the focus of this project is the development and clinical validation of a non-invasive diagnosis tool to analyse the microbiota, adding the microbiome study to the ERA analysis.

Interventions

  • PROCEDURE Endometrial biopsy and endometrial fluid collection

Trial Details

FieldValue
Enrollment Target 452 participants
Start Date 2017-08-04
Est. Completion 2020-06-25

Sponsor

Igenomix

4 total trials

What the Registry Record Tells You About NCT03330444

The ClinicalTrials.gov registry entry for NCT03330444 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 452 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Igenomix, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Endometrial biopsy and endometrial fluid collection is the first listed.

NCT03330444 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03330444 about?

NCT03330444 is a clinical study titled "Development of a Microbiome Non-invasive Diagnosis Tool". Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (...

What is the current status of trial NCT03330444?

This trial is currently completed. The enrollment target is 452 participants. The study started on 2017-08-04. Estimated completion is 2020-06-25.

What interventions are being tested in trial NCT03330444?

The interventions under investigation include: Endometrial biopsy and endometrial fluid collection (PROCEDURE).

Who is sponsoring clinical trial NCT03330444?

This trial is sponsored by Igenomix, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.