Clinical trial

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

Name
1072.6120.322.2020
Description
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.
Trial arms
Trial start
2021-04-01
Estimated PCD
2022-10-30
Trial end
2023-10-30
Status
Completed
Treatment
Ofloxacin + Metronidazole
Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days
Arms:
Antibiotic therapy
Size
100
Primary endpoint
The incidence of CE in women with idiopathic infertility
3 months
Determination of the cut-off point of the number of plasma cells/1 mm2 defining CE
3 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized open-label comparative parallel-group study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

1 product

1 indication