New Strategies to Evaluate the Reproductive Tract Microbiome

Launched by IGENOMIX · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at new, less invasive ways to study the microbiome in the uterus, which can affect fertility and reproductive health. Researchers want to see if techniques like taking samples with a vaginal swab or from endometrial fluid are as effective and safe as the standard method, which involves a small tissue sample from the uterus called an endometrial biopsy. The study will involve women aged 18 to 50 who are either part of an egg donation program or are visiting the clinic for regular gynecological check-ups. Participants will have samples taken during a specific time in their menstrual cycle and will return for a second round of sampling after one, two, or three months.

To be eligible for this study, women must be between 18 and 50 years old and agree to participate by signing an informed consent form after learning about the study. Some women may be excluded if they are currently pregnant or if they have taken certain medications like antibiotics or probiotics shortly before the sample collection. By participating, women will help researchers understand if these new sampling techniques can provide reliable information about the uterine microbiome while reducing discomfort compared to traditional methods.

Gender

FEMALE

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.