EndometriosisNCT05824507
Endometriosis and Chronic Endometritis
A study testing Endometrial aspiration biopsies for CE diagnosis in people with Endometriosis and Pelvic Pain, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain, Infertility
- What is being tested?
- Endometrial aspiration biopsies for CE diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-45 years,
- no history of surgical treatment due to reproductive organ pathology,
- no active infection of the genital tract
Who cannot join
- abdominal surgeries performed within 6 months preceding hospitalization,
- developmental defects of the reproductive organ
- antibiotic or probiotic treatment in the last 6 months
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
Krakow, 31-501
About this study
Official title: 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.
Read the detailed description
The aim of the study is:
- 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
- Being tested
- Endometrial aspiration biopsies for CE diagnosis
- Medical subject headings
- Endometriosis, Pelvic Pain, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial aspiration biopsies for CE diagnosisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis + empiric antibiotic therapy | Active comparator | 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 Receives: Diagnostic Test: Endometrial aspiration biopsies for CE diagnosis |
| Endometriosis + no empiric antibiotic therapy | Active comparator | 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 Receives: Diagnostic Test: Endometrial aspiration biopsies for CE diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 months
Secondary outcomes (2)
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
Measured: 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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort tertiary single-center study
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof., Ph.D., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824507
- Sponsor's protocol ID
- 1072.6120.76.2021
- Status last verified
- Nov 2024
- First submitted
- 26 Mar 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40033263
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Preoperative and Persistent Chronic Endometritis in Women Surgically Treated for Pelvic Endometriosis
- ClinicalTrials.gov ID
- NCT05824507
- Acronym / sponsor ID
- 1072.6120.76.2021
- Conditions
- Endometriosis, Pelvic Pain, Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort tertiary single-center study
| Arm | Type | Receives |
|---|---|---|
| Endometriosis + empiric antibiotic therapy | Active comparator | Diagnostic Test: Endometrial aspiration biopsies for CE diagnosisWomen 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 |
| Endometriosis + no empiric antibiotic therapy | Active comparator | Diagnostic Test: Endometrial aspiration biopsies for CE diagnosisWomen 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-45 years,
- no history of surgical treatment due to reproductive organ pathology,
- no active infection of the genital tract
Key exclusion criteria (3 listed)
- abdominal surgeries performed within 6 months preceding hospitalization,
- developmental defects of the reproductive organ
- antibiotic or probiotic treatment in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial aspiration biopsies for CE diagnosis1 ml of aspirate will be taken from the uterine cavity for histopathological examination and immunohistochemistry for CE during general anesthesia for scheduled surgery | Diagnostic test | Endometriosis + empiric antibiotic therapy, Endometriosis + no empiric antibiotic therapy |
Primary outcome
The incidence and activity of CE in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
Time frame: up to 3 months
The number of plasma cells/1 High Power Field (HPF) in endometrial stroma collected by aspiration biopsy determined by immunohistochemistry
2 secondary outcomes
The correlation of CE activity with endometriosis stage in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility
Time frame: 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
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 40033263Gawron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jach, Prof., Ph.D. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial aspiration biopsies for CE diagnosis in people with Endometriosis and Pelvic Pain, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and activity of CE in study population of women undergoing surgical treatment for pelvic endometriosis due to pain or infertility (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.