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

Completed

• Conditions: Endometriosis
• Interventions: Other: interleukin, enzyme, hormone

• Registration Number: NCT06628479
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-06-15
• Study First Submitted: 2024-06-09
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Endometriosis patients Adenomyosis patients

Exclusion Criteria

Ovarian endometriosis Chronic pelvic pain with another reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deep infiltrative endometriosis group	interleukin, enzyme, hormone	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
control group	interleukin, enzyme, hormone	Patients operated for tubal ligation without pelvic pain

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey