- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946655
Diagnostics of Chronic Endometritis in Infertility
November 16, 2023 updated by: Iwona Magdalena Gawron, Jagiellonian University
Evaluation of the Congruity of Methods Used in the Diagnostics of Chronic Endometritis in the Course of Infertility and the Effectiveness of Antibiotic Therapy in the Context of Remission of Symptoms and Obstetric Results
Chronic endometritis (CE) is characterized by the presence of atypical plasma cell infiltrates (CD138 positive) in the endometrial stroma.
Recent analyzes suggest that CE adversely affects fertility by reducing endometrial receptivity, impairing decidualization and uterine contractility, thus increasing the risk of recurrent pregnancy loss and implantation failure.
It is likely that a significant proportion of idiopathic infertility cases are due to CE.
The diagnosis of CE is a challenge because the clinical examination and transvaginal ultrasonography are considered non-specific.
The recent scientific research has been aimed at identifying hysteroscopic CE diagnostic criteria and establishing the compatibility of ultrasonographic, hysteroscopic, histopathological (including the use of immunohistochemical testing with antibodies against human CD138) and microbiological diagnoses.
Preliminary literature results suggested that successful treatment of CE with antibiotics could improve live birth rates.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The main objective of the study is to estimate the incidence of chronic endometritis (CE) in the population of women of childbearing age who underwent hysteroscopy for infertility. The specific objectives are as follows:
- Estimation of the diagnostic congruity of hysteroscopic, histopathological and microbiological diagnoses of CE
- Estimation of the effectiveness of empirical antibiotic therapy in the treatment of CE, confirmed by normalization of the hysteroscopic appearance of the uterine cavity, normalization of histopathological results of endometrial biopsies and decrease in plasma cell count/1 mm2
- Estimation of the percentage of clinical pregnancies achieved in women subjected to empiric antibiotic therapy for CE vs. in women without treatment. The study group will consist of women of childbearing age subjected hysteroscopy due to idiopathic infertility. The prerequisite for hysteroscopy is a normal cervical cytology result, a negative blood pregnancy test, a normal vaginal biocenosis and the first phase of the cycle. During hysteroscopy, the following will be performed: visual inspection of the uterine cavity in search of focal lesions and features of the endometrium suggestive of CE, such as: focal or diffuse hyperemia, micropolyps, stromal edema, then collection of washings from the uterine cavity for microbiological examination (aerobic and anaerobic culture, PCR for Chlamydia, culture for Mycoplasma, Ureaplsma) and excision of the focal lesion or endometrial biopsy. The extracted tissue material will be subjected to standard histopathological examination with hematoxylin and eosin staining. Additional immunohistochemical staining with Monoclonal Mouse Anti-Human CD138 antibodies will be used to detect plasmocytes. The cut-off point for the number of CE-defining plasmocytes will be determined by the Receiver Operating Characteristic (ROC) curve. Women with infertility diagnosed with CE will be randomized to 2 arms: 1) ofloxacin 2x200 mg orally for 10 days + metronidazole 1x500 mg vaginally for 10 days, 2) control arm (no treatment). After 3 cycles from surgery or completion of treatment, women will undergo a repeat hysteroscopy for a visual assessment of the uterine cavity and a follow-up endometrial biopsy. The percentage of women with improvement in the clinical appearance of the uterine cavity, normalization of histopathology and persistent CE in both arms will be determined. Data will be obtained on the results of infertility treatment (obtaining a clinical pregnancy) within 12 months of the procedure or completion of antibiotic therapy.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Malopolska
-
Krakow, Malopolska, Poland, 31-501
- Jagiellonian University Medical College, Department of Gynecology and Obstetrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 18-45 years
- lack of previous diagnosis and treatment due to suspected pathology of the uterine cavity
- lack of active infection of the reproductive tract
Exclusion Criteria:
- pelvic surgery performed within 6 months preceding the hysteroscopy
- confirmed pelvic endometriosis
- antibiotic or probiotic treatment within 3 months preceding the hysteroscopy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antibiotic therapy
Women with infertility diagnosed with CE undergoing empirical antibiotic therapy
|
Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days
|
No Intervention: Control
Women with infertility diagnosed with CE not subjected to empirical antibiotic therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of CE in women with idiopathic infertility
Time Frame: 3 months
|
Estimation of the percentage of women diagnosed with CE in the population of women with idiopathic infertility
|
3 months
|
Determination of the cut-off point of the number of plasma cells/1 mm2 defining CE
Time Frame: 3 months
|
Diagnostic compatibility assessment of immunohistochemistry and histopathology will be performed to estimate the cut-off point for the number of plasma cells defining CE using the ROC (Receiver Operating Characteristic) curve
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the reliability of polyp visualization in diagnosing CE
Time Frame: 3 months
|
The percentage of women with CE and a hysteroscopy-visible endometrial polyp and without a polyp will be calculated and compared
|
3 months
|
Assessment of the reliability of the visualization of focal endometrial hyperemia in the diagnosis of CE
Time Frame: 3 months
|
The percentage of women with CE and hysteroscopy-visible focal hyperemia and without hyperaemia will be calculated and compared
|
3 months
|
Assesment of the reliability of the visualization of diffuse endometrial hyperemia in the diagnosis of CE
Time Frame: 3 months
|
The percentage of women with CE and hysteroscopy-visible diffuse hyperaemia and without hyperaemia will be calculated and compared
|
3 months
|
Assessment of the reliability of the visualization of endometrial micropolyps in the diagnosis of CE
Time Frame: 3 months
|
The percentage of women with CE and hysteroscopy-visible micropolyps and without micropolyps will be calculated and compared
|
3 months
|
Assessment of the reliability of the visualization of endometrial edema in the diagnosis of CE
Time Frame: 3 months
|
The proportion of women with CE and hysteroscopy-visible endometrial edema and without endometrial edema will be calculated and compared
|
3 months
|
Evaluation of the effectiveness of antibiotic therapy in the context of reducing the number of plasma cells/1 mm2
Time Frame: 3 months
|
The number of plasma cells/1 mm2 will be calculated and compared among women who received antibiotic therapy in the course of CE and untreated women
|
3 months
|
Evaluation of the effectiveness of antibiotic therapy in the context of visual normalization of the uterine cavity in follow-up hysteroscopy
Time Frame: 3 months
|
The percentage of women with persistent hysteroscopic CE symptoms: visualization of focal hyperemia or diffuse hyperemia or endometrial micropolyps or endometrial edema in follow-up hysteroscopy will be assessed and compared among women who received antibiotic therapy in the course of CE and untreated women
|
3 months
|
Evaluation of the effectiveness of antibiotic therapy in the context of normalization of histopathological results of a control endometrial biopsy
Time Frame: 3 months
|
The percentage of women with persistent histopathological CE symptoms: presence of plasma cells and/or other inflammatory cells (lymphocytes or neutrophilic granulocytes or histiocytes/macrophages or eosinophilic granulocytes) destructing the endometrial tubuli among women who received antibiotic therapy in the course of CE and untreated women will be evaluated and compared in follow-up hysteroscopic endometrial biopsy
|
3 months
|
Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent infertility
Time Frame: 12 months
|
Pregnancy rates will be assessed and compared among women who received antibiotics for CE and untreated women
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the frequency of isolation of a specific pathogen in the course of CE
Time Frame: 3 months
|
The co-occurrence of a specific pathogen in CE and its type will be assessed using conventional microbiological methods
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Robert Jach, Prof., PhD, Jagiellonian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
June 29, 2023
First Submitted That Met QC Criteria
July 7, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Uterine Diseases
- Adnexal Diseases
- Pelvic Inflammatory Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Infertility
- Endometritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Metronidazole
- Ofloxacin
Other Study ID Numbers
- 1072.6120.322.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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