NCT03019679

Brief Summary

In this study the investigators aimed to investigate whether there is a relation between polycystic ovary syndrome and serum endocan levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 11, 2017

Last Update Submit

January 28, 2021

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Serum endocan level and its relationship with Polycystic Ovary Syndrome

    3 months

Study Arms (2)

Study group

Patients with polycystic ovary syndrome

Control group

Patients without polycyctic ovary syndrome

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

84 women with PCOS and 84 healty women as control group.

You may qualify if:

  • to 45 years
  • Patients diagnosed with PCOS according to Rotterdam criteris (for the study group)
  • Patients without PCOS and menstrual irregularities (for the control group)
  • Absence of significant abnormalities on physical examination except hirsutism
  • No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
  • Normal thyroid function and prolactin level
  • Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

You may not qualify if:

  • Pregnant
  • Ovarian tumors
  • Endocrine diseases (Cushing disease, 21-Hydroxylase enzyme deficiency, thyroid dysfunction,hyperprolactinemia,diabetes)
  • Chronic diseases (renal insufficiency, cardiovascular, hepatic disease)
  • Oral contraceptive use, anti-androgenic,glucocorticoid, anti-hypertansive- anti-diabetic drug use
  • Smoking or alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60000, Turkey (Türkiye)

Location

Biospecimen

Retention: NONE RETAINED

serum samples,centrifuged

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ilhan B Delibas, M.D.

    Gaziosmanpasa University Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

  • Esra Laloglu, M.D.

    Erzurum Halk Saglıgı Laboratuvarı

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

TU(1)