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Clinical Trials/NCT06495151
NCT06495151
Completed
Not Applicable

Evaluation of Serum and Peritoneal Fluid Mannose-binding Lectin Associated Serine Protease-3, Adipsin, Properdin, and Complement Factor H Levels in Endometriosis Patients

Ankara City Hospital Bilkent1 site in 1 country58 target enrollmentJune 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Ankara City Hospital Bilkent
Enrollment
58
Locations
1
Primary Endpoint
Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level
Status
Completed
Last Updated
last year

Overview

Brief Summary

Endometriosis is a chronic gynecological condition affecting nearly 10% of women of reproductive age. A definitive diagnosis of endometriosis requires laparoscopy. Studies aim to identify novel biomarkers to aid in the development of effective noninvasive diagnostic methods. Despite several theories, the full understanding of the etiopathogenesis remains elusive. A distorted immune response is thought to play a crucial role in the pathophysiology of endometriosis. This study aimed to evaluate whether the levels of alternative complement molecules change in the blood serum and peritoneal fluid of endometriosis patients compared to healthy subjects.

Detailed Description

Endometriosis is a chronic gynecological condition affecting nearly 10% of women of reproductive age. It has been reported to contribute to 21-47% of cases of female infertility and 71-87% of cases involving chronic pelvic pain. The definitive diagnosis of endometriosis requires laparoscopy. While CA-125 has diagnostic value, it is not specific to endometriosis. Therefore, studies are focused on identifying novel biomarkers to aid in the development of effective noninvasive diagnostic methods. Despite numerous theories, the etiopathogenesis of endometriosis remains incompletely understood. A distorted immune response is believed to play a crucial role in the pathophysiology of the condition. Regarding alterations in the classical and lectin-dependent complement systems, C3a, C3c, C4, and C5b-9 have been suggested to hold potential diagnostic value in endometriosis. Alternative pathway is another way for complement activation. This study aimed to investigate whether there are alterations in the levels of alternative complement molecules in both the blood serum and peritoneal fluid of patients diagnosed with endometriosis, comparing these levels to those found in healthy individuals. The research focused on understanding potential differences that could contribute to the pathophysiology of endometriosis, aiming to provide insights into the role of the alternative complement pathway in this gynecological condition.

Registry
clinicaltrials.gov
Start Date
June 10, 2022
End Date
October 7, 2022
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Didem Eşkin Tanrıverdi

Medical Doctor

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of endometriosis for study group who underwent laparoscopic endometriosis surgery
  • Healthy women for control group

Exclusion Criteria

  • Cardiovascular diseases including hypertension
  • Type 1 or type 2 diabetes mellitus
  • Morbid obesity
  • Primary adrenal insufficiency
  • Uterine fibroids
  • Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
  • Hepatic dysfunctions
  • Renal insufficiency
  • Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
  • Neurologic diseases

Outcomes

Primary Outcomes

Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level

Time Frame: day 1

Nanogram/milliliter

Serum and peritoneal fluid properdin level

Time Frame: day 1

Nanogram/milliliter

Serum and peritoneal fluid adipsin level

Time Frame: day 1

Nanogram/milliliter

Serum and peritoneal fluid complement factor H level

Time Frame: day 1

Nanogram/milliliter

Secondary Outcomes

  • Serum cancer antigen 125 level(day 1)

Study Sites (1)

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