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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03765905
Other study ID # Karadeniz Technical University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date February 1, 2018

Study information

Verified date December 2018
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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. ,


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
study
Scube-1 scube-2 scube-3

Locations

Country Name City State
Turkey Karadeniz Technical University Faculty of Medicine Trabzon Ortahisar

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum SCUBE 1 Serum scube1 in microgram 01.01.2017-31.12.2017
Primary Serum SCUBE 2 Serum scube2 in microgram 01.01.2017-31.12.2017
Primary Serum SCUBE 3 Serum scube3 in microgram 01.01.2017-31.12.2017
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