The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
NCT ID: NCT05337072
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1000 participants
OBSERVATIONAL
2023-05-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Despite limited research so far, it recently became clear that the endometrium is colonized by micro-organisms (the microbiome). However, it is still unclear what role these microorganisms play in chronic endometritis and fertility problems. Chronic endometritis is often diagnosed in the context of fertility problems, and the patient is treated 'blindly' with broad-spectrum antibiotics such as doxycycline. Broad-spectrum antibiotics unnecessarily eradicate many microorganisms in our body, including the ones that positively influence implantation. The exact cause of chronic endometritis is unknown, so treatment remains empirical. The research and knowledge in the endometrial microbiome is constantly expanding, mainly due to the rise of research into the links between pathologies and human microbiota. It is becoming increasingly clear that the composition of the microbiome can play a vital role in health and disease. Regarding the influence of the endometrial microbiome on different pathologies, such as chronic endometritis and implantation failure or miscarriage, there is still no consensus. Despite multiple studies on the endometrial microbiome, we are not yet able to define a normal or healthy endometrial microbiome.
In this project, we want to gain insight into the microorganisms that are present in the female reproductive tract based on various techniques. The analyses will performed on an endometrial biopsy and a vaginal swab. The biopsy is routinely taken at Brussels IVF for the detection of plasma cells in the anatomopathology lab for the diagnosis of chronic endometritis. In the microbiology lab we will investigate which microorganisms are present in the female reproductive tract with and without the histological diagnosis of chronic endometritis. This will be done based on the state-of-the-art analytical techniques metagenomics (sequencing) and culturomics (culture).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis
NCT04103242
The Role of Novel Organisms in Acute Endometritis
NCT01236131
Development of a Microbiome Non-invasive Diagnosis Tool
NCT03330444
Diagnostics of Chronic Endometritis in Infertility
NCT05946655
Endometrial Flora in Women Undergoing IVF Treatments
NCT03208595
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Despite limited research so far, it recently became clear that the endometrium is colonized by micro-organisms (the microbiome). However, it is still unclear what role these microorganisms play in chronic endometritis and fertility problems. Chronic endometritis is often diagnosed in the context of fertility problems, and the patient is treated 'blindly' with broad-spectrum antibiotics such as doxycyclin. Broad-spectrum antibiotics unnecessarily eradicate many microorganisms in our body, including the ones that positively influence implantation. The exact cause of chronic endometritis is unknown, so treatment remains empirical. The research and knowledge in the endometrial microbiome is constantly expanding, mainly due to the rise of research into the links between pathologies and human microbiota. It is becoming increasingly clear that the composition of the microbiome can play a vital role in health and disease. Regarding the influence of the endometrial microbiome on different pathologies, such as chronic endometritis and implantation failure or miscarriage, there is still no consensus. Despite multiple studies on the endometrial microbiome, we are not yet able to define a normal or healthy endometrial microbiome.
In this project, we want to gain insight into the microorganisms that are present in the female reproductive tract based on various techniques. The analyses will performed on an endometrial biopsy and a vaginal swab. The biopsy is routinely taken at Brussels IVF for the detection of plasma cells in the anatomopathology lab for the diagnosis of chronic endometritis. In the microbiology lab we will investigate which microorganisms are present in the female reproductive tract with and without the histological diagnosis of chronic endometritis. This will be done based on the state-of-the-art analytical techniques metagenomics (sequencing) and culturomics (culture)\*. With metagenomics we detect genetic material of the micro-organisms directly in the samples, with culturomics we grow as many species as possible from the samples using a complex culture schedule, after which we identify these microorganisms using mass spectrometry. Culturomics is a new technique that has already been applied with great success abroad on various sample types resulting in the discovery of many new bacterial species. This technique has never been applied to vaginal swabs/endometrial biopsies, making it a very innovative project. The techniques culturomics and metagenomics are complementary to each other in obtaining a very complete picture of the microbiome.
It will be evaluated whether the microbiome of endometrial biopsies and vaginal swabs can offer help in the choice of an appropriate antibiotic when chronic endometritis is diagnosed in a patient. We will evaluate the microbiome at baseline and before and after treatment with (broad-spectrum) antibiotics, currently the first-choice being doxycyclin. We will examine what effect the antibiotic treatment has on the composition of the microbiome, to what extent the balance between "good and bad" bacteria has been restored and whether the histological signs (plasma cells) of chronic endometritis disappear.
The microbiological results will be compared to the classification score based on the presence of plasma cells. In this way, this unique classification score, which was developed in the anatomopathology laboratory of UZ Brussel, can be validated. Based on this classification score, a robust diagnosis is possible for a disease for which no substantiated diagnosis is available to date.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Microbiome study
Investigation of the vaginal and endometrial microbiome
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women who undergo a diagnostic hysteroscopy in preparation of their treatment
Exclusion Criteria
* In the occurence If a previous history of chronic endometritis and the use of antibiotics in the last 3 months.
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Demuyser
Microbiologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FLORA-project
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.