New Strategies to Evaluate the Reproductive Tract Microbiome

NCT06920797 | Completed

• 1 other identifier: IGX1-MIC-DV-24-04
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility; Infertility; Reproductive Health; Microbiome Analysis

Keywords

endometrial microbiome; Microbiome; Reproductive tract; Pathogenic bacteria; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of minimally invasive techniques for the analysis of the endometrial microbiome

  Assessment of the viability and technical reliability of the new sampling techniques (endometrial fluid -EF- and vaginal swab -VS-) to evaluate the endometrial microbiome, compared with the standard sampling technique, the endometrial biopsy - EB-. The endometrial microbiome composition will be determined by DNA extraction and bacterial profiling from the three samples (endometrial biopsy -EB-, endometrial fluid -EF- and vaginal swab -VS-). The EB microbiome will serve as reference and it will be compared with the EF's and VS's microbiome to determine whether they are equivalent.

  From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group))

Secondary Outcomes (2)

• Evaluation of the inter-cycle consistency of the microbial profile in a period of 1 to 3 months

  From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group))

• Safety evaluation of the sampling techniques (EB, EF and VS)

  From enrollment to the end of the study (from 1 to 3 months, depending on the assigned group)

Other Outcomes (1)

• Correlation of the VS's and EF's pH with the microbiome

  From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group))

Study Arms (1)

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.

Diagnostic Test: Reproductive tract microbiome analysis

Interventions

Reproductive tract microbiome analysis DIAGNOSTIC_TEST

Assessment of the endometrial and vaginal microbiome in three different samples: endometrial biopsy (EB), endometrial fluid (EF) and vaginal swab (VS).

Endometrial and vaginal microbiome description

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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 whose samples will be taken during the secretory phase of the natural menstrual cycle.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

Vida Recoletas Sevilla

Seville, Seville, 41092, Spain

Location

MeSH Terms

Conditions

Infertility; Dysbiosis

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 10, 2025
• Study Start: June 9, 2025
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)