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Completed

NCT Number: NCT06495151

Endometriosis and Complement System

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannose-binding lectin-associated serine protease-3 (MASP-3) Level

Diagnostic Test

Measurement of venous blood serum and peritoneal fluid levels of MASP-3 level by ELISA method.

Adipsin Level

Diagnostic Test

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

Properdin Level

Diagnostic Test

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

Complement Factor H (CFH) Level

Diagnostic Test

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

Cancer Antigen 125 (CA-125) Level

Diagnostic Test

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

Primary outcomes

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

    Time frame: day 1

    Nanogram/milliliter

  2. Serum and peritoneal fluid adipsin level

    Time frame: day 1

    Nanogram/milliliter

  3. Serum and peritoneal fluid properdin level

    Time frame: day 1

    Nanogram/milliliter

  4. Serum and peritoneal fluid complement factor H level

    Time frame: day 1

    Nanogram/milliliter

Secondary outcomes

  1. Serum cancer antigen 125 level

    Time frame: day 1

    Unit/milliliter

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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