NCT06826495

Brief Summary

Changes in Thiol Disulfide Balance and Oxidative Stress Mechanisms in Patients with Endometrial Polyps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

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 2, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
7 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

1 year

First QC Date

February 7, 2025

Last Update Submit

February 12, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Oxidative stress markers

    Total antioxidant status (μmol Trolox equivalent/ L)

    From January 2021 to January 2022

  • Oxidative stress markers

    Total oxidant status (μmol H2O2 equivalent/L)

    From January 2021 to January 2022

  • Oxidative stress markers

    Oxidative stress index (arbitrary unit)

    From January 2021 to January 2022

  • Oxidative stress markers

    Paraoxonase (U/L)

    From January 2021 to January 2022

  • Oxidative stress markers

    Arylesterase (Ku/l)

    From January 2021 to January 2022

  • Oxidative stress markers

    Total thiol (µmol / L)

    From January 2021 to January 2022

  • Oxidative stress markers

    Native thiol (µmol / L) / alb (g / l)

    From January 2021 to January 2022

  • Oxidative stress markers

    Disulfide (-S-S-) (µmol / L) / alb (g/l)

    From January 2021 to January 2022

  • Oxidative stress markers

    Ischemia-modified albumin (u/L)

    From January 2021 to January 2022

Study Arms (2)

endometrial polyps

Women with endometrial polyp

control group

Participants in the control group were confirmed to be free of endometrial polyps via TVUSG and saline infusion ultrasonography

Eligibility Criteria

Age20 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A total of fifty-four participants, aged 20 to 48, took part in the study, including twenty-four women diagnosed with endometrial polyps and thirty women as the control group.

You may qualify if:

  • For participants in the control group:
  • To be without endometrial polyp
  • For the polyp group, they were as follows:
  • Individuals experiencing menometrorrhagia
  • A body mass index (BMI) of 25 or more
  • Hypertension
  • Endometrial polyps detected via saline infusion ultrasonography

You may not qualify if:

  • Pregnancy
  • Diabetes mellitus
  • Pelvic mass
  • Malignancy
  • The use of Tamoxifen, hormonal contraceptives, or hormone replacement therapy.

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

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 7, 2025

First Posted

February 14, 2025

Study Start

January 2, 2021

Primary Completion

January 3, 2022

Study Completion

January 5, 2022

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations