Evaluation of Serum and Peritoneal Fluid Mannose-binding Lectin Associated Serine Protease-3, Adipsin, Properdin, and Complement Factor H Levels in Endometriosis Patients
Sponsor study identifier
observational
58
1 country
1
Study Start
June 10, 2022
Actual (reported)Primary Completion
September 12, 2022
Actual (reported)Study Completion
October 7, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 7, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 10, 2022
Actual (reported)September 12, 2022
Actual (reported)October 7, 2022
Actual (reported)July 3, 2024
Actual (reported)July 10, 2024
Actual (reported)Serum and peritoneal fluid mannose-binding lectin-associated serine protease-3 level
Nanogram/milliliter
day 1
Serum and peritoneal fluid adipsin level
Nanogram/milliliter
day 1
Serum and peritoneal fluid properdin level
Nanogram/milliliter
day 1
Serum and peritoneal fluid complement factor H level
Nanogram/milliliter
day 1
Serum cancer antigen 125 level
day 1
* The study group included 32 women with endometriosis. * The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery.
* 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.
Measurement of venous blood serum and peritoneal fluid levels of MASP-3 level by ELISA method.
Measurement of venous blood serum and peritoneal fluid levels of adipsin level by ELISA method.
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.
Ankara Bilkent City Hospital
Ankara, 06100, Turkey (Türkiye)
Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
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.
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.
Serum samples were collected via antecubital venous blood sampling. In the study group, serum samples were obtained just before laparoscopy, while peritoneal fluid (PF) samples were collected from the Douglas pouch at the time of trochar insertion into the abdominal cavity. Serum and PF MASP-3, adipsin, properdin, and CFH levels were evaluated.
Merve Didem Eşkin Tanrıverdi, MD
Ankara City Hospital Bilkent
58 participants (actual enrollment reported by the registry).
First Submitted
July 3, 2024
First Posted
July 10, 2024
Study Start
June 10, 2022
Actual (reported)Research OutSmarts Endometriosis II Study
Measurement of venous blood serum and peritoneal fluid levels of properdin level by ELISA method.
Measurement of venous blood serum and peritoneal fluid levels of CFH level by ELISA method.
Measurement of venous blood serum level of CA-125 level by ELISA method.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
September 12, 2022
Actual (reported)Study Completion
October 7, 2022
Actual (reported)Last Updated
July 12, 2024
Record last verified: 2024-07
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