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AzTrials

Endometritis; ChronicFLORANCT05337072

The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI

An observational study of Endometritis; Chronic and Subfertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Endometritis; Chronic, Subfertility
What is being tested?
Microbiome study
How many people
1,000 participants
Where
1 siteBelgium
Study dates
1 Jul 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: We will include women planned for IVF/ICSI treatment at Brussels IVF (UZ Brussel) who undergo a diagnostic hysteroscopy in preparation of their treatment.

Who may be able to join

  • Women planned for IVF/ICSI treatment at Brussels IVF (UZ Brussel)
  • Women who undergo a diagnostic hysteroscopy in preparation of their treatment

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site, 1 recruiting
  • Universitair Ziekenhuis Brussel

    Brussels, 1090

    Thomas Demuyser, PhD, 003224749648, thomas.demuyser@uzbrussel.be

    Shari Mackens, PhD, 003224749361, shari.mackens@uzbrussel.be

    Recruiting

Other trials in Belgium

About this study

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Today, diagnosis of chronic endometritis is not evident, since no well-validated classification scales are available. In the UZ Brussel the pathology department applies its own in-house scoring system, based on the presence and position of plasma cells within the histological images.

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 a transvaginal ultrasound, endometrial biopsies which will be harvested during (guided biopsy) and after (blind pipelle biopsy) the hysteroscopy 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).

Read the detailed description

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Today, diagnosis of chronic endometritis is not evident, since no well-validated classification scales are available. In the UZ Brussel the pathology department applies its own in-house scoring system, based on the presence and position of plasma cells within the histological images.

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 a transvaginal ultrasound, endometrial biopsies which will be harvested during (guided biopsy) and after (blind pipelle biopsy) the hysteroscopy 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.

Being tested
Microbiome study
Keywords
Microbiome
Medical subject headings
Endometritis, Bronchiolitis Obliterans Syndrome, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microbiome studyDiagnostic test

    Investigation of the vaginal and endometrial microbiome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiome analysis through sequencing and culture

    The vaginal and endometrial microbiome will be evaluated through metagenomics sequencing and high-troughput culturomics.

    Metagenomics:

    An amplicon sequencing technique will be applied. Deep-sequencing metagenomic analysis will be performed. Microbiome bioinformatics and statistical data analyses will be performed through Quantitative Insights Into Microbial Ecology - QIIME2®. Community composition, biodiversity, and statistically different abundant taxa will be identified using appropriate statistical models, and visualisation methods.

    Culturomics:

    Two different pre-incubation conditions will be applied. We enrich both an aerobic and an anaerobic bloodculture bottle with sterile rumen fluid, sterile defibrinated sheep blood and a homemade supplement mix. Eight different agar plates will be used. After five days of incubation, all different bacterial and fungal colonies will be isolated for MALDI-TOF MS or 16S rRNA sequencing.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start1 Jul 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337072
Sponsor's protocol ID
FLORA-project
Acronym
FLORA
Status last verified
May 2026
First submitted
6 Apr 2022
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endometritis; Chronic and Subfertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiome analysis through sequencing and culture (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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