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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Spain
Vida Recoletas Sevilla
RECRUITING
Seville
Contact Information
Primary
Carlos Gómez De La Cruz, BSc MSc
carlos.gomez@igenomix.com
+34 963905310
Backup
Diana Valbuena, MD PhD
diana.valbuena@igenomix.com
+34 963905310
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2026-04
Participants
Target number of participants: 50
Treatments
Endometrial and vaginal microbiome description
Participants in this group will undergo two rounds of samples collection, 1, 2 or 3 months apart, as assigned by the investigator.
Related Therapeutic Areas
Sponsors
Leads: Igenomix

This content was sourced from clinicaltrials.gov