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RECRUITING
NCT06920797

New Strategies to Evaluate the Reproductive Tract Microbiome

Sponsor: Igenomix

View on ClinicalTrials.gov

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.

Official title: Evaluation of New Strategies in the Analysis of the Reproductive Tract Microbiome: A Descriptive Pilot Study

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-06-09

Completion Date

2026-04

Last Updated

2025-06-18

Healthy Volunteers

Yes

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).

Locations (1)

Vida Recoletas Sevilla

Seville, Seville, Spain