Endometriosis and Complement System

July 11, 2024 updated by: Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study population includes a total of 58 participants. The study group consists of 32 women with the diagnosis of endometriosis, and the control group consists of 26 healthy women.

Description

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
  • Psychiatric disorders
  • Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
  • History of any malignancy
  • History of exposure to chemotherapeutic agents or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endometriosis group (Study group)
  • The study group included 32 women with endometriosis.
  • The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
Diagnostic test: Mannose-binding lectin-associated serine protease-3 (MASP-3) Level
Measurement of venous blood serum and peritoneal fluid levels of MASP-3 level by ELISA method.
Diagnostic test: Adipsin Level
Measurement of venous blood serum and peritoneal fluid levels of adipsin level by ELISA method.
Diagnostic test: Properdin Level
Measurement of venous blood serum and peritoneal fluid levels of properdin level by ELISA method.
Diagnostic test: Complement Factor H (CFH) Level
Measurement of venous blood serum and peritoneal fluid levels of CFH level by ELISA method.
Diagnostic test: Cancer Antigen 125 (CA-125) Level
Measurement of venous blood serum level of CA-125 level by ELISA method.
Healthy women (Control group)
  • Control group consisted of 26 healthy women.
  • The control group consisted of women who consecutively visited the outpatient clinic for routine gynecologic examinations and had no known diseases.
Diagnostic test: Mannose-binding lectin-associated serine protease-3 (MASP-3) Level
Measurement of venous blood serum and peritoneal fluid levels of MASP-3 level by ELISA method.
Diagnostic test: Adipsin Level
Measurement of venous blood serum and peritoneal fluid levels of adipsin level by ELISA method.
Diagnostic test: Properdin Level
Measurement of venous blood serum and peritoneal fluid levels of properdin level by ELISA method.
Diagnostic test: Complement Factor H (CFH) Level
Measurement of venous blood serum and peritoneal fluid levels of CFH level by ELISA method.
Diagnostic test: Cancer Antigen 125 (CA-125) Level
Measurement of venous blood serum level of CA-125 level by ELISA method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level
Time Frame: day 1
Nanogram/milliliter
day 1
Serum and peritoneal fluid adipsin level
Time Frame: day 1
Nanogram/milliliter
day 1
Serum and peritoneal fluid properdin level
Time Frame: day 1
Nanogram/milliliter
day 1
Serum and peritoneal fluid complement factor H level
Time Frame: day 1
Nanogram/milliliter
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum cancer antigen 125 level
Time Frame: day 1
Unit/milliliter
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Merve Didem Eşkin Tanrıverdi, MD, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-22-1998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD are available which may be shared in necessary conditions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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