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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2020-06-25 |
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Full Details on ClinicalTrials.gov ↗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.
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