RecruitingNCT06920797

New Strategies to Evaluate the Reproductive Tract Microbiome

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


Sponsor

Igenomix

Enrollment

50 participants

Start Date

Jun 9, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria1

  • 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 Criteria3

  • 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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Interventions

DIAGNOSTIC_TESTReproductive 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

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NCT06920797


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