Evaluation of MG53 (TRIM72) Levels in Women With Polycystic Ovary Syndrome: An Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention (observational study).
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS), Insulin Resistance Syndrome. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Serum MG53 level [Time frame: Baseline (single time point at enrollment)]
Secondary outcome measures (4)
- Correlation between MG53 levels and insulin resistance (HOMA-IR) [Time frame: 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)]
- Correlation between MG53 levels and hormonal parameters [Time frame: 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- University of Health Sciences, Gaziosmanpaşa Training and Research Hospital — Gaziosmanpaşa
Publications
- Coskun ES, Gencer FK, Salman S, Nurlu N, Bacak HB, Kumbasar S, Timur GY, Celikoglu E, Unlu S, Tunccag F, Guven R. Decreased serum MG53 levels are associated with SHBG and androgen excess in women with polycystic ovary syndrome. Sci Rep. 2026 Apr 13;16(1):15753. doi: 10.1038/s41598-026-48800-z. PMID 41974999
Identifiers
NCT: NCT07094776 · MG53GOP