NCT06826625

Brief Summary

The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 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 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Polycystic Ovarian Syndrome (PCOS)Oxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Oxidative stress markers

    TAS, TOS, OSI, PON, ARES, total thiol, native thiol, disulfide (-S-S-), reduced thiol, oxidized thiol, and IMA

    From January 2021 to December 2021

Study Arms (2)

polycystic ovary syndrome

Woman with PCOS

control

Women without PCOS

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Woman with and without polycystic ovary syndrome

You may qualify if:

  • The PCOS group included patients with oligomenorrhea (menstrual period intervals of more than 35 days), clinical signs of hyperandrogenism (acne or hirsutism), biochemical signs of hyperandrogenism (with total testosterone of 100 ng/dL and above and patients with dehydroepiandrosterone sulfate of 400 g/dl and above), an LH/FSH ratio of over 3 on the second day of the menstrual period, a body mass index of 25 and above, and polycystic ovaries detected in suprapubic ultrasonography.

You may not qualify if:

  • Pregnant individuals, individuals with diabetes mellitus, metabolic syndrome, adrenal pathology, pelvic mass, and malignancy were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Training and Research Hospital Gynecology and Obstetrics Department

Antalya, Turkey (Türkiye)

Location

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

January 2, 2021

Primary Completion

December 30, 2021

Study Completion

February 1, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

TU(1)