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Endometriosis and Chronic Endometritis

Primary Purpose

Endometriosis, Pelvic Pain, Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Endometrial aspiration biopsies for CE diagnosis
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endometriosis + empiric antibiotic therapy

Endometriosis + no empiric antibiotic therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
March 26, 2023
Last Updated
April 20, 2023
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT05824507
Brief Title
Endometriosis and Chronic Endometritis
Official Title
The Incidence of Preoperative and Persistent Chronic Endometritis in Women Surgically Treated for Pelvic Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pelvic Pain, Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort tertiary single-center study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endometriosis + empiric antibiotic therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Endometriosis + no empiric antibiotic therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Endometrial aspiration biopsies for CE diagnosis
Intervention Description
1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery
Primary Outcome Measure Information:
Title
The incidence and activity of CE in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
Description
The number of plasma cells/1 High Power Field (HPF) in endometrial stroma collected by aspiration biopsy determined by immunohistochemistry
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
The correlation of CE activity with endometriosis stage in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
Description
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
Time Frame
up to 3 months
Title
Comparison of the frequency of persistent CE in the group subjected to postoperative empirical antibiotic therapy and in the untreated group
Description
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
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iwona M. Gawron, Ph.D.
Phone
+48 124248570
Email
iwona.gawron@uj.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Jach, Prof., Ph.D.
Phone
+48 124248571
Email
robert.jach@uj.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jach, Prof., Ph.D.
Organizational Affiliation
Jagiellonian University
Official's Role
Study Chair
Facility Information:
Facility Name
Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iwona M. Gawron, Ph.D.
Phone
+48 124248570
Email
iwona.gawron@gmail.com
First Name & Middle Initial & Last Name & Degree
Robert Jach, Prof., Ph.D.
Phone
+48 124248571
Email
robert.jach@uj.edu.pl
First Name & Middle Initial & Last Name & Degree
Iwona M. Gawron, Ph.D.
First Name & Middle Initial & Last Name & Degree
Andrzej Zmaczyński, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Endometriosis and Chronic Endometritis

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