Clinical trial NCT06628479: Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in Women With Chronic Pelvic Pain
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Chronic pelvic pain
Deep infiltrative endometriosis
Relaxin
IL-6
MMP-2
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: University of Health Sciences School of Medicine Bursa Yuksek Ihtisas Research and Training Hospital, Department of Obstetrics and Gynecology, Bursa, Turkey
First posted: 2024-10-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

Endometriosis patients Adenomyosis patients

Exclusion Criteria:

Ovarian endometriosis Chronic pelvic pain with another reason

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References: