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CompletedNCT06495151Updated Jul 12, 2024

Endometriosis and Complement System

An observational study in Endometriosis, Complement System and Alternative Complement Pathway, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
58
Ages
18 Years to 44 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Endometriosis
  • Complement System
  • Alternative Complement Pathway

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 58 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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 · Diagnostic Test: Adipsin Level · Diagnostic Test: Properdin Level · Diagnostic Test: Complement Factor H (CFH) Level · Diagnostic Test: Cancer Antigen 125 (CA-125) Level

  • 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 · Diagnostic Test: Adipsin Level · Diagnostic Test: Properdin Level · Diagnostic Test: Complement Factor H (CFH) Level · Diagnostic Test: Cancer Antigen 125 (CA-125) Level

Interventions

  • 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 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 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.

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What researchers measure

Primary outcomes

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

    Nanogram/milliliter

    Time frame: day 1

  2. Serum and peritoneal fluid adipsin level

    Nanogram/milliliter

    Time frame: day 1

  3. Serum and peritoneal fluid properdin level

    Nanogram/milliliter

    Time frame: day 1

  4. Serum and peritoneal fluid complement factor H level

    Nanogram/milliliter

    Time frame: day 1

Secondary outcomes

  1. Serum cancer antigen 125 level

    Unit/milliliter

    Time frame: day 1

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Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, 06100, Turkey
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References and documents

Publications

  • Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469. PubMed 29420391 ↗
  • Chapron C, Marcellin L, Borghese B, Santulli P. Rethinking mechanisms, diagnosis and management of endometriosis. Nat Rev Endocrinol. 2019 Nov;15(11):666-682. doi: 10.1038/s41574-019-0245-z. Epub 2019 Sep 5. PubMed 31488888 ↗
  • Karadadas E, Hortu I, Ak H, Ergenoglu AM, Karadadas N, Aydin HH. Evaluation of complement system proteins C3a, C5a and C6 in patients of endometriosis. Clin Biochem. 2020 Jul;81:15-19. doi: 10.1016/j.clinbiochem.2020.04.005. Epub 2020 Apr 20. PubMed 32325082 ↗
  • Kabut J, Kondera-Anasz Z, Sikora J, Mielczarek-Palacz A. Levels of complement components iC3b, C3c, C4, and SC5b-9 in peritoneal fluid and serum of infertile women with endometriosis. Fertil Steril. 2007 Nov;88(5):1298-303. doi: 10.1016/j.fertnstert.2006.12.061. Epub 2007 May 4. PubMed 17482181 ↗
  • Xu Y, Ma M, Ippolito GC, Schroeder HW Jr, Carroll MC, Volanakis JE. Complement activation in factor D-deficient mice. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14577-82. doi: 10.1073/pnas.261428398. Epub 2001 Nov 27. PubMed 11724962 ↗
  • Ricklin D, Hajishengallis G, Yang K, Lambris JD. Complement: a key system for immune surveillance and homeostasis. Nat Immunol. 2010 Sep;11(9):785-97. doi: 10.1038/ni.1923. Epub 2010 Aug 19. PubMed 20720586 ↗
  • Poppelaars F, Faria B, Schwaeble W, Daha MR. The Contribution of Complement to the Pathogenesis of IgA Nephropathy: Are Complement-Targeted Therapies Moving from Rare Disorders to More Common Diseases? J Clin Med. 2021 Oct 14;10(20):4715. doi: 10.3390/jcm10204715. PubMed 34682837 ↗
  • Liu M, Luo X, Xu Q, Yu H, Gao L, Zhou R, Wang T. Adipsin of the Alternative Complement Pathway Is a Potential Predictor for Preeclampsia in Early Pregnancy. Front Immunol. 2021 Oct 4;12:702385. doi: 10.3389/fimmu.2021.702385. eCollection 2021. PubMed 34671343 ↗
  • Gursoy Calan O, Calan M, Yesil Senses P, Unal Kocabas G, Ozden E, Sari KR, Kocar M, Imamoglu C, Senses YM, Bozkaya G, Bilgir O. Increased adipsin is associated with carotid intima media thickness and metabolic disturbances in polycystic ovary syndrome. Clin Endocrinol (Oxf). 2016 Dec;85(6):910-917. doi: 10.1111/cen.13157. Epub 2016 Aug 15. PubMed 27434652 ↗
  • Zhang J, Teng F, Pan L, Guo D, Liu J, Li K, Yuan Y, Li W, Zhang H. Circulating adipsin is associated with asymptomatic carotid atherosclerosis in obese adults. BMC Cardiovasc Disord. 2021 Oct 25;21(1):517. doi: 10.1186/s12872-021-02329-3. PubMed 34696714 ↗
  • Barratt J, Weitz I. Complement Factor D as a Strategic Target for Regulating the Alternative Complement Pathway. Front Immunol. 2021 Sep 9;12:712572. doi: 10.3389/fimmu.2021.712572. eCollection 2021. PubMed 34566967 ↗
  • Lei X, Song X, Fan Y, Chen Z, Zhang L. The Role and Potential Mechanism of Complement Factor D in Fibromyalgia Development. J Pain Res. 2023 Dec 19;16:4337-4351. doi: 10.2147/JPR.S439689. eCollection 2023. PubMed 38145036 ↗
  • Agostinis C, Balduit A, Mangogna A, Zito G, Romano F, Ricci G, Kishore U, Bulla R. Immunological Basis of the Endometriosis: The Complement System as a Potential Therapeutic Target. Front Immunol. 2021 Jan 11;11:599117. doi: 10.3389/fimmu.2020.599117. eCollection 2020. PubMed 33505394 ↗
  • Chen LH, Lo WC, Huang HY, Wu HM. A Lifelong Impact on Endometriosis: Pathophysiology and Pharmacological Treatment. Int J Mol Sci. 2023 Apr 19;24(8):7503. doi: 10.3390/ijms24087503. PubMed 37108664 ↗
  • Garred P, Genster N, Pilely K, Bayarri-Olmos R, Rosbjerg A, Ma YJ, Skjoedt MO. A journey through the lectin pathway of complement-MBL and beyond. Immunol Rev. 2016 Nov;274(1):74-97. doi: 10.1111/imr.12468. PubMed 27782323 ↗

Individual participant data

Plan to share: No — IPD are available which may be shared in necessary conditions.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06495151
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Merve Didem Eşkin Tanrıverdi (Medical Doctor, Ankara City Hospital Bilkent) — Principal investigator
First posted
Jul 10, 2024
Start date
Jun 10, 2022
Primary completion
Sep 12, 2022
Completion
Oct 7, 2022
Last update
Jul 12, 2024

Study contacts

Merve Didem Eşkin Tanrıverdi, MD
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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