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

NCT ID: NCT07094776

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2025-08-20

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.

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.

Conditions

Polycystic Ovary Syndrome (PCOS); Insulin Resistance Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No intervention (observational study)

Intervention Type: 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

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.

No intervention (observational study)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Havva Betül Bacak

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Betül Bacak

M.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Enes S Coşkun, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Locations

University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Gaziosmanpaşa, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MG53GOP

Identifier Type: -

Identifier Source: org_study_id