Polycystic Ovary Syndrome (PCOS)PCOSMG53NCT07094776
Evaluation of MG53 (TRIM72) Levels in Women With Polycystic Ovary Syndrome: An Observational Study
An observational study of Polycystic Ovary Syndrome (PCOS) and Insulin Resistance Syndrome, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Insulin Resistance Syndrome
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jun 2025to 20 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Currently pregnant
- Presence of chronic systemic disease
- Use of metformin or any hormonal treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
Gaziosmanpaşa, Istanbul, 34255
About this study
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.
Read more
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.
Read the 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.
- Being tested
- No intervention (observational study)
- Keywords
- MG53, TRIM72, Polycystic Ovary Syndrome, PCOS, Insulin Resistance, Metabolic Markers, ELISA, Cross-Sectional Study, HOMA-IR, SHBG, Androgen Index, Lipid Profile
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (single time point at enrollment)
Secondary outcomes (4)
Correlation between MG53 levels and insulin resistance (HOMA-IR)
Association between MG53 levels and HOMA-IR index derived from fasting glucose and insulin.
Measured: At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and BMI
Association between MG53 levels and body mass index (BMI).
Measured: At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and hormonal parameters
Association between MG53 levels and LH/FSH ratio, total testosterone, DHEA-S, SHBG, and free androgen index.
Measured: At the time of blood draw (single measurement at enrollment)
Correlation between MG53 levels and lipid parameters
Association between MG53 levels and triglycerides, HDL-cholesterol, LDL-cholesterol, and total cholesterol.
Measured: At the time of blood draw (single measurement at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Jun 2025
- Primary completion20 Aug 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- Enes S Coşkun, M.D., Principal investigator, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094776
- Sponsor's protocol ID
- MG53GOP
- Acronym
- PCOSMG53
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 41974999
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MG53 (TRIM72) Levels in Women With Polycystic Ovary Syndrome: An Observational Study
- ClinicalTrials.gov ID
- NCT07094776
- Acronym / sponsor ID
- PCOSMG53 / MG53GOP
- Keywords
- MG53, TRIM72, Polycystic Ovary Syndrome, PCOS, Insulin Resistance, Metabolic Markers, ELISA, Cross-Sectional Study
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS Group | – | Other: No intervention (observational study)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. |
| Healthy Controls | – | Other: No intervention (observational study)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Currently pregnant
- Presence of chronic systemic disease
- Use of metformin or any hormonal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Healthy Controls, PCOS Group |
Primary outcome
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)
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 41974999Coskun 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enes S Coşkun, M.D. principal investigator
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS) and Insulin Resistance Syndrome, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum MG53 level (time frame: Baseline (single time point at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07094776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.