Endometriosis and Chronic Endometritis

NCT ID: NCT05824507

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-09-30

Brief Summary

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.

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.

Conditions

Endometriosis; Pelvic Pain; Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Endometrial aspiration biopsies for CE diagnosis

Intervention Type: DIAGNOSTIC_TEST

1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery

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

Group Type: ACTIVE_COMPARATOR

Endometrial aspiration biopsies for CE diagnosis

Intervention Type: DIAGNOSTIC_TEST

1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Iwona Magdalena Gawron

Ph.D., Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Jach, Prof., Ph.D.

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology

Krakow, , Poland

Countries

Poland

References

Gawron I, Derbisz K, Jach R, Trojnarska D, Milian-Ciesielska K, Pietrus M. Pelvic peritoneal endometriosis is linked to the endometrial inflammatory profile: a prospective cohort study. BMC Womens Health. 2025 Mar 3;25(1):94. doi: 10.1186/s12905-025-03632-3.

Reference Type: DERIVED

PMID: 40033263 (View on PubMed)

Other Identifiers

1072.6120.76.2021

Identifier Type: -

Identifier Source: org_study_id