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Endometriosis and Complement System

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06495151
Enrollment
58
Registered
2024-07-10
Start date
2022-06-10
Completion date
2022-10-07
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alternative Complement Pathway, Complement System, Endometriosis

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.

Interventions

DIAGNOSTIC_TESTAdipsin Level

Measurement of venous blood serum and peritoneal fluid levels of adipsin level by ELISA method.

DIAGNOSTIC_TESTProperdin Level

Measurement of venous blood serum and peritoneal fluid levels of properdin level by ELISA method.

DIAGNOSTIC_TESTMannose-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_TESTComplement Factor H (CFH) Level

Measurement of venous blood serum and peritoneal fluid levels of CFH level by ELISA method.

DIAGNOSTIC_TESTCancer Antigen 125 (CA-125) Level

Measurement of venous blood serum level of CA-125 level by ELISA method.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 levelday 1Nanogram/milliliter
Serum and peritoneal fluid adipsin levelday 1Nanogram/milliliter
Serum and peritoneal fluid properdin levelday 1Nanogram/milliliter
Serum and peritoneal fluid complement factor H levelday 1Nanogram/milliliter

Secondary

MeasureTime frameDescription
Serum cancer antigen 125 levelday 1Unit/milliliter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026