NCT06358300

Brief Summary

We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

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, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

Polycystic ovary syndromeVisceral Adiposity IndexPCOS Subtypes

Outcome Measures

Primary Outcomes (1)

  • Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome

    Since there are different metabolic effects in different subtypes of polycystic ovary syndrome; In this study we aimed to investigate whether there is a difference between VAI in different PCOS subtypes and the difference between these subtypes and the healthy group.

    Eight months

Study Arms (5)

Controls

Healthy controls between aged 18-35 years

PCOS Subtype 1

Hyperandrogenemia+oligoanovulation+PCO appearance on USG

PCOS Subtype 2

Hyperandrogenemia+oligoanovulation

PCOS Subtype 3

Hyperandrogenemia+PCO appearance on USG

PCOS Subtype 4

Oligoanovulation+PCO appearance on USG

Eligibility Criteria

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

Woman aged between 18 and 35, age-matched between groups, diagnosed with PCOS and without a known cancer diagnosis, liver and kidney failure, not taking medications that would affect HDL, TG levels and insulin resistance and without active infection.

You may qualify if:

  • Patients who applied for reasons such as hair growth, acne, menstrual irregularity or infertility and were diagnosed with PCOS after examination, biochemical, hormonal and sonographic tests,
  • Female patients between the ages of 18-35,
  • Patients without known cancer, liver or kidney failure,
  • Patients who do not take medications that will affect HDL, TG levels and insulin resistance,
  • Female patients without active infection will be included. -

You may not qualify if:

  • Female patients under eighteen years of age and \>35 years of age,
  • Patients with known cancer, liver and kidney failure,
  • Patients taking medications that will affect HDL, TG levels and insulin resistance,
  • Patients with active infection will not be included in the study. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak Training and Research Hospital

Uşak, 64100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

After 8-12 hours of fasting, 2-3 ml of blood will be taken for serum HDL and TG measurement. Blood will be centrifuged and frozen at -70 °C.

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 Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
16 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

January 1, 2022

Primary Completion

September 1, 2022

Study Completion

July 20, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations