The FLORA project: looking for endometrium microbes linked to chronic endometritis and pregnancy success
Official title: The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
Run by Universitair Ziekenhuis Brussel · NCT05337072 · Data updated 2026-11-12
This study tests the relationship between the endometrial microbiome and chronic endometritis in women undergoing IVF/ICSI.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | July 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT05337072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women planning IVF/ICSI at Brussels IVF (UZ Brussel) who will have a diagnostic hysteroscopy as part of their treatment plan.
✕Probably not a fit
Patients who do not have endometrial inflammation or whose microbial patterns do not relate to implantation outcomes may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study explores whether the endometrial microbiome is associated with chronic endometritis and fertility outcomes in women planning IVF/ICSI. Researchers will analyze diagnostic hysteroscopy samples to characterize microbial composition and inflammation markers using the center’s scoring system for plasma cells. The goal is to see if specific microbial patterns correlate with endometritis and implantation success. Participation is limited to women scheduled for IVF/ICSI at Universitair Ziekenhuis Brussel who have a diagnostic hysteroscopy as part of their treatment workup.
Why it matters
Potential benefit: If successful, the findings could guide more targeted, microbiome-informed approaches to improving implantation and pregnancy rates.
How similar studies have gone: Previous research suggests the endometrial microbiome may be linked to implantation, but clear, widely applicable results are still developing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women planned for IVF/ICSI treatment at Brussels IVF (UZ Brussel) * Women who undergo a diagnostic hysteroscopy in preparation of their treatment Exclusion criteria: * If an interventional instead of a diagnostic hysteroscopy in planned * In the occurence If a previous history of chronic endometritis and the use of antibiotics in the last 3 months.
Where it's running
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Universitair Ziekenhuis Brussel
Brussels, Belgium Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.