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.
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
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Thomas Demuyser, PhD, 003224749648, thomas.demuyser@uzbrussel.be
Shari Mackens, PhD, 003224749361, shari.mackens@uzbrussel.be
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.
- Conditions
- Endometritis; Chronic, Subfertility
- 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.
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.
- First posted20 Apr 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometritis; ChronicStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05337072
- Acronym / sponsor ID
- FLORA / FLORA-project
- Conditions
- Endometritis; Chronic, Subfertility
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Women planned for IVF/ICSI treatment at Brussels IVF (UZ Brussel)
- Women who undergo a diagnostic hysteroscopy in preparation of their treatment
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome studyInvestigation of the vaginal and endometrial microbiome | Diagnostic test | – |
Primary outcome
Microbiome analysis through sequencing and culture
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.