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Recruiting NCT06920797

New Strategies to Evaluate the Reproductive Tract Microbiome

Trial Parameters

Condition Fertility
Sponsor Igenomix
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2025-06-09
Completion 2026-04
Interventions
Reproductive tract microbiome analysis

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Women, between 18 and 50 years, coming form the donor program and/or patients from the General Gynaecology Unit who attend to routine gynaecological controls to the clinic and who voluntarily accept to participate and sign the corresponding informed consent approved by the Ethics Committee, once they have been dully informed of the study's nature and knoe the potential risks, benefits and discomforts. Exclusion Criteria: * Ongoing pregnancy. * Samples not obtained during the secretory phase of a natural cycle. * Intake of any antibiotic, probiotic and/or antifungal in the 7 days prior to the sample collection of the first cycle.

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