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

NCT ID: NCT06628479

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-06-15

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.

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

interleukin, enzyme, hormone

Intervention Type: OTHER

Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples

control group

Patients operated for tubal ligation without pelvic pain

interleukin, enzyme, hormone

Intervention Type: OTHER

Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples

Interventions

interleukin, enzyme, hormone

Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples

Intervention Type: OTHER

Other Intervention Names

relaxin; mmp-2; ıl-6

Eligibility Criteria

Inclusion Criteria

Endometriosis patients Adenomyosis patients

Exclusion Criteria

Ovarian endometriosis Chronic pelvic pain with another reason

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nefise Nazlı YENIGUL

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2011-KAEK-25 2022/05-18

Identifier Type: -

Identifier Source: org_study_id