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

NCT07094776 | Enrolling By Invitation

• 1 other identifier: MG53GOP
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS); Insulin Resistance Syndrome

Keywords

MG53; TRIM72; Polycystic Ovary Syndrome; PCOS; Insulin Resistance; Metabolic Markers; ELISA; Cross-Sectional Study; HOMA-IR; SHBG; Androgen Index; Lipid Profile

Outcome Measures

Primary Outcomes (1)

• Serum MG53 level

  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 Outcomes (4)

• Correlation between MG53 levels and insulin resistance (HOMA-IR)

  At the time of blood draw (single measurement at enrollment)

• Correlation between MG53 levels and BMI

  At the time of blood draw (single measurement at enrollment)

• Correlation between MG53 levels and hormonal parameters

  At the time of blood draw (single measurement at enrollment)

• Correlation between MG53 levels and lipid parameters

  At the time of blood draw (single measurement at enrollment)

Study Arms (2)

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)

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)

Interventions

No intervention (observational study) OTHER

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; PCOS Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Havva Betül Bacak: lead

Study Sites (1)

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome; Insulin Resistance

Interventions

Observation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Enes S Coşkun, M.D.

  University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: June 18, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)