Diagnostics of Chronic Endometritis in Infertility

NCT05946655 | Completed DMC

• 1 other identifier: 1072.6120.322.2020
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility Unexplained; Abnormal Uterine Bleeding; Intrauterine Disorder

Keywords

Infertility Unexplained; Chronic endometritis; Office hysteroscopy; Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Assessment of the reliability of polyp visualization in diagnosing CE

  3 months

• Assessment of the reliability of the visualization of focal endometrial hyperemia in the diagnosis of CE

  3 months

• Assesment of the reliability of the visualization of diffuse endometrial hyperemia in the diagnosis of CE

  3 months

• Assessment of the reliability of the visualization of endometrial micropolyps in the diagnosis of CE

  3 months

• Assessment of the reliability of the visualization of endometrial edema in the diagnosis of CE

  3 months

Other Outcomes (1)

• Evaluation of the frequency of isolation of a specific pathogen in the course of CE

  3 months

Study Arms (2)

Antibiotic therapy

EXPERIMENTAL

Women diagnosed with CE undergoing empirical antibiotic therapy

Drug: Ofloxacin + Metronidazole

Control

NO INTERVENTION

Women diagnosed with CE not subjected to empirical antibiotic therapy

Interventions

Ofloxacin + Metronidazole DRUG

Ofloxacin 2x200mg orally for 10 days + Metronidazole 1x500 mg vaginally for 10 days

Antibiotic therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• pelvic surgery performed within 6 months preceding the hysteroscopy
• confirmed pelvic endometriosis
• antibiotic or probiotic treatment within 3 months preceding the hysteroscopy

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, Malopolska, 31-501, Poland

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Ofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert Jach, Prof., PhD

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Principal Investigator

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 14, 2023
• Study Start: April 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)