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New Strategies to Evaluate the Reproductive Tract Microbiome

NCT06920797 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of this observational study is to evaluate alternative less invasive sampling methods for the analysis of the endometrial microbiome. For that, vaginal swab and endometrial fluid samples will be assessed in comparison with the standard sampling method (an endometrial biopsy), in women aged 18-50 years on an oocyte donation program and/or who attend the clinic for routine gynecological controls, and whose samples will be collected during the secretory phase of a natural menstrual cycle. The study aims to:

* Evaluate the pontential of the less invasive techniques to assess the endometrial microbiome, compared to the endometrial biopsy, as well as their safety.
* Evaluate the microbiome's stability in a period of 1 to 3 months.

Participants will undergo a sampling round (of the 3 sampling methods), and then a second round 1, 2 or 3 months later, as assigned by the investigator.

Conditions

Interventions

DIAGNOSTIC_TEST

Reproductive tract microbiome analysis

Assessment of the endometrial and vaginal microbiome in three different samples: endometrial biopsy (EB), endometrial fluid (EF) and vaginal swab (VS).

Sponsors & Collaborators

  • Igenomix

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2026-02-18
Completion
2026-02-18

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920797 on ClinicalTrials.gov