NCT06495151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 3, 2024

Last Update Submit

July 11, 2024

Conditions

EndometriosisComplement SystemAlternative Complement Pathway

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (1)

  • Serum cancer antigen 125 level

    day 1

Study Arms (2)

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

Interventions

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

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

Endometriosis group (Study group)Healthy women (Control group)
Adipsin LevelDIAGNOSTIC_TEST

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

Endometriosis group (Study group)Healthy women (Control group)
Properdin LevelDIAGNOSTIC_TEST

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

Endometriosis group (Study group)Healthy women (Control group)
Complement Factor H (CFH) LevelDIAGNOSTIC_TEST

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

Endometriosis group (Study group)Healthy women (Control group)
Cancer Antigen 125 (CA-125) LevelDIAGNOSTIC_TEST

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

Endometriosis group (Study group)Healthy women (Control group)

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis is the presence of endometrial tissue outside the uterus, such as in the ovaries, fallopian tubes, peritoneal membrane, or abdominal cavity, and it is diagnosed exclusively in females.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (15)

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

    PMID: 29420391BACKGROUND

  • 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.

    PMID: 31488888BACKGROUND

  • 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.

    PMID: 32325082BACKGROUND

  • 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.

    PMID: 17482181BACKGROUND

  • 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.

    PMID: 11724962BACKGROUND

  • 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.

    PMID: 20720586BACKGROUND

  • 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.

    PMID: 34682837BACKGROUND

  • 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.

    PMID: 34671343BACKGROUND

  • 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.

    PMID: 27434652BACKGROUND

  • 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.

    PMID: 34696714BACKGROUND

  • 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.

    PMID: 34566967BACKGROUND

  • 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.

    PMID: 38145036BACKGROUND

  • 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.

    PMID: 33505394BACKGROUND

  • 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.

    PMID: 37108664BACKGROUND

  • 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.

    PMID: 27782323BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Merve Didem Eşkin Tanrıverdi, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 10, 2024

Study Start

June 10, 2022

Primary Completion

September 12, 2022

Study Completion

October 7, 2022

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

IPD are available which may be shared in necessary conditions.

Locations

TU(1)