New Strategies to Evaluate the Reproductive Tract Microbiome (NCT06920797) | Clinical Trial Compass
CompletedNot Applicable
New Strategies to Evaluate the Reproductive Tract Microbiome
Spain57 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of minimally invasive techniques for the analysis of the endometrial microbiome
Timeframe: From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group))