NCT03765905

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

June 22, 2018

Last Update Submit

December 5, 2018

Conditions

Keywords

PCOSSCUBECardiovascular disease

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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

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

Interventions

studyDIAGNOSTIC_TEST

Scube-1 scube-2 scube-3

PCOS diagnosis areaPCOS is not diagnosed

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of PCOS
  • years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University Faculty of Medicine

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Polycystic Ovary SyndromeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Süleyman Güven, Prof

    Karadeniz TU Medicine Faculty

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 22, 2018

First Posted

December 5, 2018

Study Start

December 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations