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Completed

NCT Number: NCT06628479

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

35 year–72 year

Sex eligibility

Female

Study type

Observational

Primary location

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Endometriosis patients Adenomyosis patients

Exclusion criteria

Ovarian endometriosis Chronic pelvic pain with another reason

Treatment and study plan

interleukin, enzyme, hormone

Other

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

Other names: relaxin, mmp-2, ıl-6

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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