Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in Women With Chronic Pelvic Pain

October 3, 2024 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in Women With Chronic Pelvic Pain, Diagnosis of Deep Infiltrative Endometriosis and Investigation of it is Place in Follow-up

In our study, by evaluating the serum and vaginal-peritoneal fluid levels of Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in women over 35 years of age with chronic pelvic pain, the investigators aimed to reveal their potential to be an important marker in the diagnosis of Deep Infiltrative Endometriosis, thus enabling early diagnosis with lower cost and results that can be obtained in a short time.The investigators aim to reveal its relationship with follow-up.

In our study, the values of Relaxin, MMP-2 or IL-6 from vaginal fluids were found to be significantly higher than the control group in the prediction and follow-up of deep infiltrative endometriosis. This supports the role of Relaxin and MMP-2 as well as IL-6 in the pathophysiology of deep infiltrative endometriosis.

Histologically based and multicenter randomized controlled studies with more patients are needed to elucidate the etiology and pathophysiology of endometriosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

10 cc of vaginal washing fluid, serum samples on the day of operation and 20 cc of pelvic washing fluid during laparoscopy were taken from all patients before the operation. Patients were included in the FA group according to the ENZIAN Classification. Patients' age, BMI, gravida, parity, obstetric history such as pregnancy, ethnic origin, educational status, preoperative and postoperative evaluation for chronic pelvic pain, laboratory tests (routine tests such as Ca125, CRP, FSH, LH, E2, P), Preoperative and postoperative hormonal values were recorded. Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples of the patients in the control and study groups were compared.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16110
        • Nefise nazlı Yenigül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

People over the age of 35 who have completed their fertility, do not want children and have chronic pelvic patients with pain

Description

Inclusion Criteria:

Endometriosis patients Adenomyosis patients

Exclusion Criteria:

Ovarian endometriosis Chronic pelvic pain with another reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deep infiltrative endometriosis group
People over the age of 35 who have completed their fertility, do not want children and have chronic pelvic endometriosis with pain or patients diagnosed with adenomyosis due to abnormal uterine bleeding
Other: interleukin, enzyme, hormone
Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples
Other Names:
  • relaxin
  • mmp-2
  • ıl-6
control group
Patients operated for tubal ligation without pelvic pain
Other: interleukin, enzyme, hormone
Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples
Other Names:
  • relaxin
  • mmp-2
  • ıl-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of the role of Relaxin, Matrix Metalloproteinase-2 and Interleukin 6 in the diagnosis and follow-up of deep infiltrative endometriosis in women with chronic pelvic pain
Time Frame: 6 months
Quantitative levels of Relaxin, MMP-2, and IL-6 in serum will be measured. The levels of these biomarkers will be reported as concentrations in nanograms per milliliter (ng/mL) for serum. These measurements aim to establish the correlation between biomarker levels and the presence of Deep Infiltrative Endometriosis (DIE) in women over 35 years of age with chronic pelvic pain.
6 months
Investigation of the role of Relaxin, Matrix Metalloproteinase-2 and Interleukin 6 in the diagnosis and follow-up of deep infiltrative endometriosis in women with chronic pelvic pain
Time Frame: 6 months
Quantitative levels of Relaxin, MMP-2, and IL-6 in vaginal-peritoneal fluid will be measured. The levels of these biomarkers will be reported as concentrations in micromoles per liter (µmol/L) for vaginal-peritoneal fluid. These measurements aim to establish the correlation between biomarker levels and the presence of Deep Infiltrative Endometriosis (DIE) in women over 35 years of age with chronic pelvic pain.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Collaborators

University of Health Sciences School of Medicine Bursa Yuksek Ihtisas Research and Training Hospital, Department of Obstetrics and Gynecology, Bursa, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2022/05-18

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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