Endometriosis and Chronic Endometritis

The Incidence of Preoperative and Persistent Chronic Endometritis in Women Surgically Treated for Pelvic Endometriosis

Pelvic endometriosis is a complex estrogen-dependent inflammatory syndrome of unknown etiology, altering the microenvironment of the peritoneal cavity and probably endometrial receptivity, and adversely affecting the physiological processes associated with fertilization. Literature data suggest that the distribution of immune system cells in the eutopic endometrium in the presence of endometriosis differs from the physiological state. The functioning of the immune system seems to be significantly modified not only in the foci of endometriosis, but also in the eutopic endometrium, affecting its physiological functions. Chronic endometritis (CE) is a potential factor impairing endometrial receptivity in the course of endometriosis. However, it is not known whether CE is one of the complications of endometriosis or perhaps an element of its pathogenesis. At the moment, endometrial diagnostics is not obligatory in the treatment of endometriosis in women of reproductive age, but it could potentially bring additional benefits and contribute to the improvement of obstetric results and increase the effectiveness of infertility treatment in women with endometriosis.

Study Overview

• Status: Completed
• Conditions: Infertility; Endometriosis; Pelvic Pain
• Intervention / Treatment: Diagnostic test: Endometrial aspiration biopsies for CE diagnosis

Detailed Description

The aim of the study is:

i) Evaluation of the incidence and activity of CE (expressed as the number of plasma cells / 1 High Power Field, HPF) in women undergoing surgical treatment for pelvic endometriosis due to pain or infertility; ii) Evaluation of the correlation of CE activity (expressed as the number of plasma cells/ 1 HPF) with endometriosis staging according to the American Society for Reproductive Medicine Classification System iii) Evaluation of the impact of surgical removal of pelvic endometriosis foci on CE activity iv) Comparison of the percentage of women with persistent CE after surgery in the subgroup receiving empiric antibiotics (Amoxicillin + Clavulanic Acid 875 mg + 125 mg, twice daily orally for 7 days) and the subgroup without antibiotics. The study will include women aged 18-45 undergoing laparoscopic surgery for pelvic endometriosis. Additionally, an endometrial aspiration biopsy will be performed. Endometriosis will be confirmed by histopathology. The stage of endometriosis will be determined according to revised American Society for Reproductive Medicine Classification. CE will be confirmed by histopathology and immunohistochemical staining with monoclonal murine antibodies against human plasma cells CD138, and will be defined as the presence of plasma cells in the endometrial stroma, the value will be given as the number of plasma cells/1 High Power Field (HPF) and the cut-off will be calculated using the receiver operating characteristic (ROC) curve. A control endometrial biopsy to confirm the effectiveness of empiric antibiotic therapy will be performed up to 3 cycles after the primary procedure.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18-45 years,
• no history of surgical treatment due to reproductive organ pathology,
• no active infection of the genital tract

Exclusion Criteria:

• abdominal surgeries performed within 6 months preceding hospitalization,
• developmental defects of the reproductive organ
• antibiotic or probiotic treatment in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endometriosis + empiric antibiotic therapy; Women undergoing laparoscopic removal of endometriotic foci due to pain/infertility and endometrial aspiration biopsy for diagnosis of CE followed by empirical antibiotic therapy of CE, if confirmed	Diagnostic test: Endometrial aspiration biopsies for CE diagnosis; 1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery
Active Comparator: Endometriosis + no empiric antibiotic therapy; Women undergoing laparoscopic removal of endometriotic foci due to pain/infertility and endometrial aspiration biopsy for diagnosis of CE without empirical antibiotic therapy of CE, if confirmed	Diagnostic test: Endometrial aspiration biopsies for CE diagnosis; 1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and activity of CE in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility	The number of plasma cells/1 High Power Field (HPF) in endometrial stroma collected by aspiration biopsy determined by immunohistochemistry	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of CE activity with endometriosis stage in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility	The correlation between the number of plasma cells/ 1HPF in endometrial stroma and the stage of endometriosis (I-IV) according to the American Society for Reproductive Medicine classification	up to 3 months
Comparison of the frequency of persistent CE in the group subjected to postoperative empirical antibiotic therapy and in the untreated group	The number of plasma cells/1 High Power Field (HPF) detected by immunohistochemistryin in endometrial stroma collected by aspiration biopsy 3 months after surgery in the group receiving postoperative empiric antibiotic therapy and in the untreated group	up to 6 months

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Robert Jach, Prof., Ph.D., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Adnexal Diseases; Pelvic Inflammatory Disease; Infertility; Endometriosis; Pelvic Pain; Endometritis
• Other Study ID Numbers: 1072.6120.76.2021

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