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New Strategies to Evaluate the Reproductive Tract Microbiome
Sponsor: Igenomix
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
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