Chronic EndometritisNCT06890754
Hysteroscopy for Chronic Endometritis: Diagnostic Performance and Observer Variability
An observational study of Chronic Endometritis, run by Tunis University at 1 site in Tunisia.
Trial summary
This study investigates the role of hysteroscopy in diagnosing chronic endometritis (CE), a condition linked to female infertility but difficult to diagnose due to nonspecific symptoms. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Chronic Endometritis
- What is being tested?
- Diagnostic hysteroscopy
- How many people
- 70 participants
- Where
- 1 siteTunisia
- Study dates
- 6 Jun 2021to 8 Aug 2022
- How long will I take part?
- 14 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consisted of infertile women aged 18 to 42 years with no uterine abnormalities on pelvic ultrasound. Exclusion criteria included biological inflammatory syndrome, recent acute genital infections (within three months), antibiotic therapy, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, and endometrial cancer. The sample size was determined based on the reported prevalence of chronic endometritis (CE) in infertile women, ranging from 2.8% to 30%, with a calculated target of 68 participants to ensure statistical significance at a 95% confidence level.
Who may be able to join
- included women aged 18 to 42 years, consulting for infertility, with a pelvic ultrasound showing no uterine abnormalities
Who cannot join
- Excluded from the study were patients with biological inflammatory syndrome, those on antibiotic therapy or with a recent acute genital infection (less than three months), autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Hysteroscopy in Diagnosing Chronic Endometritis and the Role of Intra- and Inter-Observer Variability: A Prospective Study of 70 Cases.
This study investigates the role of hysteroscopy in diagnosing chronic endometritis (CE), a condition linked to female infertility but difficult to diagnose due to nonspecific symptoms. While histological examination with CD138 ( Cluster of Differentiation 138 )immunohistochemistry is the gold standard, hysteroscopy remains widely used. This prospective, multicenter study included infertile women with no uterine abnormalities on ultrasound. Hysteroscopy was performed using standardized criteria, and its diagnostic performance was compared to histopathology. Intra- and inter-observer variability were also assessed through blinded video evaluations by two specialists. The study aimed to determine the reliability of hysteroscopy in diagnosing CE and its agreement among different observers.
Read the detailed description
This study evaluates the diagnostic performance of hysteroscopy in detecting chronic endometritis (CE), a condition associated with female infertility. CE is characterized by persistent endometrial inflammation and is challenging to diagnose due to its nonspecific clinical presentation. Histopathological examination with CD138 immunohistochemistry (IHC) is currently the gold standard for CE diagnosis, yet hysteroscopy remains a commonly used tool in clinical practice.
This prospective, multicenter study was conducted between June 6, 2021, and August 8, 2022, and included infertile women aged 18 to 42 years. Participants were selected based on normal pelvic ultrasound findings, while patients with biological inflammatory syndrome, recent acute genital infections, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer were excluded. The final cohort comprised 70 patients.
Hysteroscopy was performed during the late follicular phase (days 8-12) using a 2.9 mm 30° rigid hysteroscope with saline distension. The procedure was conducted using a "no-touch" technique to minimize endometrial trauma and ensure accurate video interpretation. Endometrial biopsies were obtained using a Novak curette for subsequent CD138 IHC analysis.
The hysteroscopic diagnosis of CE was based on standardized criteria proposed by Cicinelli et al., including micro polyps, focal and diffuse hyperaemia, stromal oedema, strawberry aspect, and haemorrhagic spots. Recorded hysteroscopic videos were independently reviewed by two reproductive medicine specialists. To assess intra- and inter-observer variability, a second blinded evaluation was conducted four weeks later by the same observers.
The study aimed to assess the sensitivity, specificity, and predictive values of hysteroscopy in diagnosing CE while evaluating the consistency of observer interpretations. By comparing hysteroscopic findings to histopathological results, the study provides insights into the reliability of hysteroscopy as a diagnostic tool for CE and highlights its limitations due to observer variability.
- Conditions
- Chronic Endometritis
- Being tested
- Diagnostic hysteroscopy
- Keywords
- Chronic endometritis, intra-observer variability, inter-observer variability, hysteroscopy, CD138
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopyDiagnostic test
Diagnostic hysteroscopy. An IHC study of the expression of the plasma cell marker CD138 was systematically performed for all samples studied
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Undergoing Diagnostic Hysteroscopy
Examination of the uterine cavity and the cervico-isthmic canal.
Measured: peroperatively
Expression of CD138 Marker in Endometrial Biopsy
An immunohistochemical study of plasma cell marker CD138 expression was systematically performed on all analyzed samples. The anti-CD138 monoclonal antibody (Clone Ml15, Leica Biosystems, Reference: PA0088), ready to use on the BOND immunohistochemistry automated system, was used.
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start6 Jun 2021
- Primary completion1 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EndometritisStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
- Target duration
- 14 Months
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haithem Aloui, Tunis University
- Investigators
- Haithem Aloui, Principal investigator, Tunis University Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890754
- Sponsor's protocol ID
- Endometrite hysteroscopy
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study's individual participant data (IPD) will be made available to researchers upon reasonable request. The shared data will include de-identified participant-level datasets containing: Demographic characteristics (age, Body Mass Index, smoking status, infertility duration, primary versus secondary infertility) Hysteroscopic findings (micro polyps, focal hyperaemia, diffuse hyperaemia, stromal oedema, strawberry aspect, haemorrhagic spots) Histopathological results (CD138, immunohistochemistry findings, plasma cell count per high-power field) Observer assessments (initial and repeat evaluations for intra- and inter-observer variability) All data will be de-identified to ensure confidentiality. Access will be granted to qualified researchers for meta-analyses, systematic reviews, or investigations related to chronic endometritis and infertility, following approval of a research proposal and data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Hysteroscopy in Diagnosing Chronic Endometritis and the Role of Intra- and Inter-Observer Variability: A Prospective Study of 70 Cases.
- ClinicalTrials.gov ID
- NCT06890754
- Acronym / sponsor ID
- Endometrite hysteroscopy
- Conditions
- Chronic Endometritis
- Keywords
- Chronic endometritis, intra-observer variability, inter-observer variability, hysteroscopy, CD138
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 24 Mar 2025 (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.
This study investigates the role of hysteroscopy in diagnosing chronic endometritis (CE), a condition linked to female infertility but difficult to diagnose due to nonspecific symptoms. While histological examination with CD138 ( Cluster of Differentiation 138 )immunohistochemistry is the gold standard, hysteroscopy remains widely used. This prospective, multicenter study included infertile women with no uterine abnormalities on ultrasound. Hysteroscopy was performed using standardized criteria, and its diagnostic performance was compared to histopathology. Intra- and inter-observer variability were also assessed through blinded video evaluations by two specialists. The study aimed to determine the reliability of hysteroscopy in diagnosing CE and its agreement among different observers.
Detailed description
This study evaluates the diagnostic performance of hysteroscopy in detecting chronic endometritis (CE), a condition associated with female infertility. CE is characterized by persistent endometrial inflammation and is challenging to diagnose due to its nonspecific clinical presentation. Histopathological examination with CD138 immunohistochemistry (IHC) is currently the gold standard for CE diagnosis, yet hysteroscopy remains a commonly used tool in clinical practice.
This prospective, multicenter study was conducted between June 6, 2021, and August 8, 2022, and included infertile women aged 18 to 42 years. Participants were selected based on normal pelvic ultrasound findings, while patients with biological inflammatory syndrome, recent acute genital infections, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer were excluded. The final cohort comprised 70 patients.
Hysteroscopy was performed during the late follicular phase (days 8-12) using a 2.9 mm 30° rigid hysteroscope with saline distension. The procedure was conducted using a "no-touch" technique to minimize endometrial trauma and ensure accurate video interpretation. Endometrial biopsies were obtained using a Novak curette for subsequent CD138 IHC analysis.
The hysteroscopic diagnosis of CE was based on standardized criteria proposed by Cicinelli et al., including micro polyps, focal and diffuse hyperaemia, stromal oedema, strawberry aspect, and haemorrhagic spots. Recorded hysteroscopic videos were independently reviewed by two reproductive medicine specialists. To assess intra- and inter-observer variability, a second blinded evaluation was conducted four weeks later by the same observers.
The study aimed to assess the sensitivity, specificity, and predictive values of hysteroscopy in diagnosing CE while evaluating the consistency of observer interpretations. By comparing hysteroscopic findings to histopathological results, the study provides insights into the reliability of hysteroscopy as a diagnostic tool for CE and highlights its limitations due to observer variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Months
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of infertile women aged 18 to 42 years with no uterine abnormalities on pelvic ultrasound. Exclusion criteria included biological inflammatory syndrome, recent acute genital infections (within three months), antibiotic therapy, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, and endometrial cancer. The sample size was determined based on the reported prevalence of chronic endometritis (CE) in infertile women, ranging from 2.8% to 30%, with a calculated target of 68 participants to ensure statistical significance at a 95% confidence level.
Key inclusion criteria (1 listed)
- included women aged 18 to 42 years, consulting for infertility, with a pelvic ultrasound showing no uterine abnormalities
Key exclusion criteria (1 listed)
- Excluded from the study were patients with biological inflammatory syndrome, those on antibiotic therapy or with a recent acute genital infection (less than three months), autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer.
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 |
|---|---|---|
| Diagnostic hysteroscopyDiagnostic hysteroscopy. An IHC study of the expression of the plasma cell marker CD138 was systematically performed for all samples studied | Diagnostic test | – |
Primary outcome
Proportion of Participants Undergoing Diagnostic Hysteroscopy
Time frame: peroperatively
Examination of the uterine cavity and the cervico-isthmic canal.
Expression of CD138 Marker in Endometrial Biopsy
Time frame: First 24 hours
An immunohistochemical study of plasma cell marker CD138 expression was systematically performed on all analyzed samples. The anti-CD138 monoclonal antibody (Clone Ml15, Leica Biosystems, Reference: PA0088), ready to use on the BOND immunohistochemistry automated system, was used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No. This study's individual participant data (IPD) will be made available to researchers upon reasonable request. The shared data will include de-identified participant-level datasets containing: Demographic characteristics (age, Body Mass Index, smoking status, infertility duration, primary versus secondary infertility) Hysteroscopic findings (micro polyps, focal hyperaemia, diffuse hyperaemia, stromal oedema, strawberry aspect, haemorrhagic spots) Histopathological results (CD138, immunohistochemistry findings, plasma cell count per high-power field) Observer assessments (initial and repeat evaluations for intra- and inter-observer variability) All data will be de-identified to ensure confidentiality. Access will be granted to qualified researchers for meta-analyses, systematic reviews, or investigations related to chronic endometritis and infertility, following approval of a research proposal and data-sharing agreement.
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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. This study is not recruiting at the moment.
Haithem Aloui principal investigator
Tunis University Manar
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 Chronic Endometritis, run by Tunis University at 1 site in Tunisia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 2025. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Undergoing Diagnostic Hysteroscopy (time frame: peroperatively). The study lists 2 primary outcomes in all. 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 26 Mar 2025.