Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,

The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Diagnostic test: study

Detailed Description

The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index.

This will be a prospective clinical laboratory study,It will include women with PCOS diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be included in the study group, which will be included in the survey after being approved for participation in the survey from field trials. Forty patients who will not have any complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control group but who had no PCOS o rany other systemic problems and will be similar in terms of age group and body mass index will be included in the study after being approved for participation in the study. From the study and control group, 5 mL of blood will be taken from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1, SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Ortahisar
    • Trabzon, Ortahisar, Turkey, 61000
      • Karadeniz Technical University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

40 women diagnosed with PCOS between the ages of 18-35

Description

Inclusion Criteria

• Clinical diagnosis of PCOS
• 18-35 years old

Exclusion Criteria

• Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder, hypercholesterolemia, sickle cell anemia or neoplasm,
• Coronary artery disease , angina or myocardial infarction, or any known vascular, infectious, or inflammatory disease, including hypertension, coronary arterioscitis, and electrocardiographic changes;
• Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone agonists and antagonists) within the previous 3 months;
• Abnormal serum albumin concentration (normal concentration, 30-55 g / l),
• Abnormal troponin I concentration,
• Present smoker,
• Abnormal renal, hepatic and thyroid function test results;
• Refusing to participate in the work.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCOS diagnosis area; The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria)	Diagnostic test: study; Scube-1 scube-2 scube-3
PCOS is not diagnosed; Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study	Diagnostic test: study; Scube-1 scube-2 scube-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum SCUBE 1	Serum scube1 in microgram	01.01.2017-31.12.2017
Serum SCUBE 2	Serum scube2 in microgram	01.01.2017-31.12.2017
Serum SCUBE 3	Serum scube3 in microgram	01.01.2017-31.12.2017

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Süleyman Güven, Prof, Karadeniz TU Medicine Faculty

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular disease; PCOS; SCUBE
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Karadeniz Technical University (Other Identifier: Karadeniz Technical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No