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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.
The objectives are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic therapy | Experimental | Women diagnosed with CE undergoing empirical antibiotic therapy |
|
| Control | No Intervention | Women diagnosed with CE not subjected to empirical antibiotic therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofloxacin + Metronidazole | Drug | Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the cut-off point of the number of plasma cells/1 HPF corresponding to histological CE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the reliability of polyp visualization in diagnosing CE | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the frequency of isolation of a specific pathogen in the course of CE | The co-occurrence of a specific pathogen in CE and its type will be assessed using conventional microbiological methods | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jach, Prof., PhD | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Medical College, Department of Gynecology and Obstetrics | Krakow | Malopolska | 31-501 | Poland |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Prospective cohort study
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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 | 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 | 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 | 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 | 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 | 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 | 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 | Pregnancy rates will be assessed and compared among women who received antibiotics for CE and untreated women | 24 months |
| Evaluation of the effectiveness of antibiotic therapy in the treatment of CE - dependent abnormal uterine bleeding | The rates of persistence of abnormal uterine bleeding will be assessed and compared in women who received antibiotics for CE and in untreated women. | 24 months |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |