Oxidative Stress in Polycystic Ovary Syndrome

Elucidation of the Oxidative Mechanism Effective in Polycystic Ovary Syndrome: a Randomized Controlled Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Polycystic Ovarian Syndrome (PCOS)

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Alanya Training and Research Hospital Gynecology and Obstetrics Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Woman with and without polycystic ovary syndrome

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
polycystic ovary syndrome; Woman with PCOS
control; Women without PCOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mardin Artuklu University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: 2020/23-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No