Investigating how immune function affects metformin treatment in PCOS patients
Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome
This study is testing how the immune system affects how well metformin works for women with Polycystic Ovary Syndrome (PCOS).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06325956 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients diagnosed with Polycystic Ovary Syndrome (PCOS) to explore the relationship between immune function and the effectiveness of metformin treatment. Participants will undergo blood sample collection and immune function analysis using flow cytometry before and after a 6-month metformin intervention. The goal is to identify immune markers that can predict how well metformin will work for individual patients with PCOS. By understanding these immune responses, the study aims to enhance treatment strategies for PCOS.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-45 who have been diagnosed with PCOS according to the Rotterdam criteria.
Not a fit: Patients who are pregnant, have thyroid disorders, severe organ dysfunction, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for women with PCOS.
How similar studies have performed: While the specific approach of linking immune function to metformin efficacy in PCOS is novel, similar studies have explored immune markers in other conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18-45 years * Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003) Exclusion Criteria: * Pregnant women; * Hyperthyroidism or hypothyroidism * Severe liver and kidney function injury * Cancer patients; * Associated with severe infection, severe anemia, neutropenia and other blood system diseases; * Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes; * Patients with mental illness or intellectual disability; * Have taken drugs for PCOS treatment in the last three months; * Have a long history of taking hormone therapy; * Currently or recently participating in another clinical trial.
Where this trial is running
Shanghai
- Department of Endocrinology, Shanghai Tenth People's Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Manna Zhang, doctor — Shanghai 10th People's Hospital
- Study coordinator: Manna Zhang, doctor
- Email: mannazhang@126.com
- Phone: +8613774448495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.