Endometriosis and Complement System

NCT ID: NCT06495151

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-10

Study Completion Date

2022-10-07

Brief Summary

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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

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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.

Conditions

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Endometriosis Complement System Alternative Complement Pathway

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type DIAGNOSTIC_TEST

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

Adipsin Level

Intervention Type DIAGNOSTIC_TEST

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

Properdin Level

Intervention Type DIAGNOSTIC_TEST

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

Complement Factor H (CFH) Level

Intervention Type DIAGNOSTIC_TEST

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

Cancer Antigen 125 (CA-125) Level

Intervention Type DIAGNOSTIC_TEST

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.

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

Intervention Type DIAGNOSTIC_TEST

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

Adipsin Level

Intervention Type DIAGNOSTIC_TEST

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

Properdin Level

Intervention Type DIAGNOSTIC_TEST

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

Complement Factor H (CFH) Level

Intervention Type DIAGNOSTIC_TEST

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

Cancer Antigen 125 (CA-125) Level

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Adipsin Level

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

Intervention Type DIAGNOSTIC_TEST

Properdin Level

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

Intervention Type DIAGNOSTIC_TEST

Complement Factor H (CFH) Level

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

Intervention Type DIAGNOSTIC_TEST

Cancer Antigen 125 (CA-125) Level

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Merve Didem Eşkin Tanrıverdi

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Didem Eşkin Tanrıverdi, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.

Reference Type BACKGROUND
PMID: 29420391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31488888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32325082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17482181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11724962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20720586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34682837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34671343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27434652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34696714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34566967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38145036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33505394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37108664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27782323 (View on PubMed)

Other Identifiers

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E2-22-1998

Identifier Type: -

Identifier Source: org_study_id

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