Clinical trial NCT05824507: Endometriosis and Chronic Endometritis
Official title: The Incidence of Preoperative and Persistent Chronic Endometritis in Women Surgically Treated for Pelvic Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Infertility
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort tertiary single-center study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The incidence and activity of CE in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
timeFrame: up to 3 months
Secondary outcomes:
measure: The correlation of CE activity with endometriosis stage in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
timeFrame: up to 3 months
measure: Comparison of the frequency of persistent CE in the group subjected to postoperative empirical antibiotic therapy and in the untreated group
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
Study officials:
affiliation: Jagiellonian University
name: Robert Jach, Prof., Ph.D.
role: STUDY_CHAIR
References: