Actively Recruiting
The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
Led by Universitair Ziekenhuis Brussel · Updated on 2026-05-15
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand chronic endometritis, an inflammation of the lining of the uterus that can affect fertility and pregnancy. It is commonly seen in about 10% of women with fertility issues. The diagnosis is challenging due to a lack of well-established classification systems, although a special scoring method using plasma cell presence is used at UZ Brussel. The study also explores the role of microorganisms in the female reproductive tract and their impact on this condition and fertility. The project involves analyzing samples from women undergoing IVF/ICSI treatment, including vaginal swabs and endometrial biopsies taken during and after hysteroscopy. These samples will be examined using advanced methods called metagenomics and culturomics to identify the microorganisms present. Researchers will compare the microbiome before and after treatment with broad-spectrum antibiotics, mainly doxycycline, to understand how these treatments affect the balance of bacteria and signs of inflammation. Participants will undergo routine diagnostic procedures such as transvaginal ultrasound, biopsies, and vaginal swabs. The study will measure the microbiome through sequencing and culture over two years, alongside the evaluation of plasma cell presence to validate the diagnostic scoring system. This process aims to improve diagnosis and guide treatment choices for chronic endometritis, supporting better fertility outcomes. Participation involves continuous monitoring of microbial changes and treatment effects throughout the study period.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women planned for IVF/ICSI treatment at Brussels IVF (UZ Brussel)
- Women who undergo a diagnostic hysteroscopy in preparation of their treatment
You will not qualify if you...
- If an interventional instead of a diagnostic hysteroscopy is planned
- History of chronic endometritis and use of antibiotics in the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - At baseline before IVF/ICSI treatment
Participants undergo diagnostic hysteroscopy with endometrial biopsies and vaginal swabs to analyze the microbiome and evaluate chronic endometritis.
1 diagnostic visit (in-person)
Duration - Up to 2 years
Participants are observed over time to study the microbiome changes and the presence of chronic endometritis during their IVF/ICSI treatment course.
Periodic assessments during IVF/ICSI treatment as per routine care
Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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