Oxidative Stress in Polycystic Ovary Syndrome | NCT06826625

Studies
Oxidative Stress in Polycystic Ovary Syndrome

NCT06826625

Sponsor

Mardin Artuklu University

Status

Completed

Last Update Posted

Feb 14, 2025Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Polycystic Ovarian Syndrome (PCOS)
Oxidative Stress

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2021Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Feb 1, 2025Actual

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
polycystic ovary syndrome		Woman with PCOS
control		Women without PCOS

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Woman with and without polycystic ovary syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alanya Training and Research Hospital Gynecology and Obstetrics Department		Antalya			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided