Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, Malopolska, 31-501, Poland
NCT Number: NCT05946655
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Krakow, Malopolska, 31-501, Poland
The objectives are as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days
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
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
Time frame: 3 months
The percentage of women with CE and hysteroscopy-visible focal hyperemia and without hyperaemia will be calculated and compared
Time frame: 3 months
The percentage of women with CE and hysteroscopy-visible diffuse hyperaemia and without hyperaemia will be calculated and compared
Time frame: 3 months
The percentage of women with CE and hysteroscopy-visible micropolyps and without micropolyps will be calculated and compared
Time frame: 3 months
The proportion of women with CE and hysteroscopy-visible endometrial edema and without endometrial edema will be calculated and compared
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
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
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
Time frame: 24 months
Pregnancy rates will be assessed and compared among women who received antibiotics for CE and untreated women
Time frame: 24 months
The rates of persistence of abnormal uterine bleeding will be assessed and compared in women who received antibiotics for CE and in untreated women.
Time frame: 3 months
The co-occurrence of a specific pathogen in CE and its type will be assessed using conventional microbiological methods
Jagiellonian University
Other
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
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