Endometriosis and Complement System

Completed

• Conditions: Alternative Complement Pathway; Endometriosis; Complement System
• Interventions: Diagnostic Test: Mannose-binding lectin-associated serine protease-3 (MASP-3) Level; Diagnostic Test: Adipsin Level; Diagnostic Test: Properdin Level; Diagnostic Test: Complement Factor H (CFH) Level; Diagnostic Test: Cancer Antigen 125 (CA-125) Level

• Registration Number: NCT06495151
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2022-06-10
• Primary Completion: 2022-09-12
• Study Completion: 2022-10-07
• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-10
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis group (Study group)	Mannose-binding lectin-associated serine protease-3 (MASP-3) Level	* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
Endometriosis group (Study group)	Properdin Level	* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
Healthy women (Control group)	Cancer Antigen 125 (CA-125) Level	* 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.
Healthy women (Control group)	Mannose-binding lectin-associated serine protease-3 (MASP-3) Level	* 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.
Endometriosis group (Study group)	Cancer Antigen 125 (CA-125) Level	* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
Endometriosis group (Study group)	Complement Factor H (CFH) Level	* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
Healthy women (Control group)	Adipsin Level	* 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.
Healthy women (Control group)	Properdin Level	* 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.
Healthy women (Control group)	Complement Factor H (CFH) Level	* 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.
Endometriosis group (Study group)	Adipsin Level	* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.

Primary Outcome Measures

Name	Time	Method
Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level	day 1	Nanogram/milliliter
Serum and peritoneal fluid properdin level	day 1	Nanogram/milliliter
Serum and peritoneal fluid adipsin level	day 1	Nanogram/milliliter
Serum and peritoneal fluid complement factor H level	day 1	Nanogram/milliliter

Secondary Outcome Measures

Name	Time	Method
Serum cancer antigen 125 level	day 1	Unit/milliliter

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey