Evaluation of MG53 (TRIM72) Levels in Women With Polycystic Ovary Syndrome: An Observational Study (PCOSMG53)

August 1, 2025 updated by: Havva Betül Bacak

Purpose of the Study:

This study is being conducted to examine a protein called MG53 (also known as TRIM72) in women with polycystic ovary syndrome (PCOS). MG53 is involved in cell membrane repair and may play a role in insulin resistance, which is common in PCOS.

Study Procedures:

Women between 18 and 45 years of age will be invited to participate. The study population will include both women diagnosed with PCOS and healthy controls. A single blood sample (approximately 5 mL) will be collected from each participant. MG53 levels will be measured using an ELISA laboratory assay.

Significance of the Study:

Analysis of MG53 levels in relation to hormonal and metabolic markers may help determine whether MG53 is associated with insulin resistance and other characteristics of PCOS.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background:

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and is often associated with insulin resistance and metabolic disturbances. MG53 (TRIM72) is a membrane repair protein that has been shown in some experimental studies to affect insulin signaling and glucose metabolism.

Rationale:

Because insulin resistance is a key feature of PCOS, investigating MG53 levels in women with PCOS may provide new insights into the pathophysiology of the syndrome. Understanding whether MG53 is elevated and how it correlates with metabolic and hormonal parameters could lead to new diagnostic or therapeutic approaches in the future.

Study Design:

This is an observational, cross-sectional, single-center study. A total of 128 participants will be included: 64 women diagnosed with PCOS (based on the Rotterdam criteria) and 64 healthy women as controls.

Procedures:

Each participant will undergo a single blood draw (approximately 5 mL). MG53 levels will be measured using an ELISA method. Routine laboratory markers associated with PCOS (including HOMA-IR, BMI, LH/FSH ratio, total testosterone, DHEA-S, SHBG, free androgen index, triglycerides, HDL, LDL, and total cholesterol) will also be recorded from standard clinical evaluations.

Data Analysis:

Statistical analysis will include normality testing (Kolmogorov-Smirnov), comparison of groups (Student's t-test or Mann-Whitney U test), and correlation analyses (Pearson or Spearman). Sample size was calculated using G*Power software.

Outcome Measures:

The primary outcome is the serum level of MG53. Secondary outcomes include the correlation between MG53 levels and metabolic/hormonal parameters.

Significance:

This study does not involve any investigational drug or device and poses minimal risk to participants. The findings may contribute to the understanding of metabolic pathways involved in PCOS.

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Gaziosmanpaşa, İstanbul, Turkey, 34255
        • University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of women aged 18 to 45 years. One group includes women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, and the other group includes healthy female controls without PCOS or other chronic conditions. All participants will provide informed consent before enrollment.

Description

Inclusion Criteria:

  • Female participants aged 18 to 45 years
  • Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria or healthy controls without PCOS
  • Able and willing to provide informed consent

Exclusion Criteria:

Currently pregnant

  • Presence of chronic systemic disease
  • Use of metformin or any hormonal treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS Group
Women aged 18-45 years diagnosed with polycystic ovary syndrome (PCOS) based on Rotterdam criteria. A single blood sample is collected for MG53 and routine metabolic markers. No intervention is applied.
Other: No intervention (observational study)
This is an observational study. No drugs, devices, or treatments are administered. Participants only provide a single blood sample for MG53 and routine metabolic measurements.
Healthy Controls
Women aged 18-45 years without PCOS or other chronic conditions. A single blood sample is collected for MG53 and routine metabolic markers. No intervention is applied.
Other: No intervention (observational study)
This is an observational study. No drugs, devices, or treatments are administered. Participants only provide a single blood sample for MG53 and routine metabolic measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum MG53 level
Time Frame: Baseline (single time point at enrollment)
Serum MG53 levels measured by ELISA in women with PCOS and healthy controls. Time Frame: At the time of blood draw (single measurement at enrollment)
Baseline (single time point at enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between MG53 levels and insulin resistance (HOMA-IR)
Time Frame: At the time of blood draw (single measurement at enrollment)
Association between MG53 levels and HOMA-IR index derived from fasting glucose and insulin.
At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and BMI
Time Frame: At the time of blood draw (single measurement at enrollment)
Association between MG53 levels and body mass index (BMI).
At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and hormonal parameters
Time Frame: At the time of blood draw (single measurement at enrollment)
Association between MG53 levels and LH/FSH ratio, total testosterone, DHEA-S, SHBG, and free androgen index.
At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and lipid parameters
Time Frame: At the time of blood draw (single measurement at enrollment)
Association between MG53 levels and triglycerides, HDL-cholesterol, LDL-cholesterol, and total cholesterol.
At the time of blood draw (single measurement at enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Havva Betül Bacak

Investigators

  • Principal Investigator: Enes S Coşkun, M.D., University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Estimated)

August 20, 2025

Study Completion (Estimated)

August 20, 2025

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

July 23, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG53GOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because this study does not include a plan for public data sharing, and participant consent for data sharing has not been obtained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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