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

NCT06628479 | Completed DMC

• 1 other identifier: 2011-KAEK-25 2022/05-18
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Chronic pelvic pain; Deep infiltrative endometriosis; Relaxin; IL-6; MMP-2

Outcome Measures

Primary Outcomes (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

  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

  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

Study Arms (2)

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

control group

Patients operated for tubal ligation without pelvic pain

Other: interleukin, enzyme, hormone

Interventions

interleukin, enzyme, hormone OTHER

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

Also known as: relaxin, mmp-2, ıl-6

Deep infiltrative endometriosis group; control group

Eligibility Criteria

• Age: 35 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Endometriosis patients Adenomyosis patients

You may not qualify if:

• Ovarian endometriosis Chronic pelvic pain with another reason

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead
• University of Health Sciences School of Medicine Bursa Yuksek Ihtisas Research and Training Hospital, Department of Obstetrics and Gynecology, Bursa, Turkey: collaborator

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Interleukins; Enzymes; Hormones; Relaxin; Matrix Metalloproteinase 2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Enzymes and Coenzymes; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Corpus Luteum Hormones; Gonadal Hormones; Peptide Hormones; Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Gelatinases; Matrix Metalloproteinases, Secreted; Matrix Metalloproteinases; Metalloproteases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: October 8, 2024
• Study Start: June 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: June 15, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)