Polycystic Ovary Syndrome
Conditions
Interventions
Control group:Medication (Drospirenone and Ethinylestradiol Tablets + Metformin Hydrochloride Tablets)
Intervention group:Medication (Drospirenone and Ethinylestradiol Tablets + Metformin Hydrochloride Tablets) + Lifestyle Intervention (Diet and Exercise Plans)
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
Female
Age
22 Years to 37 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for PCOS; 2. Infertility-related anovulation or infrequent ovulation; clinical manifestations of hyperandrogenism (e.g., acne) and/or hyperandrogenemia; polycystic ovarian changes (=12 follicles with a diameter of 2–9 mm in one or both ovaries) fulfilling 2 out of the 3 criteria above, with other causes of hyperandrogenism excluded. 3. Note: In our hospital's gynecology outpatient department, hyperandrogenemia is monitored (e.g., testosterone >2.6 ng/ml or free testosterone >3.09 nmol/L). 4. Age between 21 and 40 years; 5. Body mass index (BMI) >=24 kg/m²; 6. Fertility requirements, willing to use contraception during the trial, voluntarily consenting to participate in the study after being fully informed; 7. Regular follow-up at our hospital, willing to accept mobile app and telephone follow-up; 8. Capable of operating a smartphone and related software independently; 9. Education level: Junior high school or higher.
Exclusion criteria
Exclusion criteria: 1. Used supplements that affect ovarian function in the past 3 months, including oral contraceptives (e.g., Diane-35), antipsychotic drugs, or other medications affecting hormone levels (e.g., glucocorticoids, amiloride); 2. History of ovarian cysts or ovarian tumor surgery; 3. Diabetes patients currently undergoing insulin therapy; 4. Currently taking antidiabetic medications other than insulin sensitizers (e.g., metformin, pioglitazone); 5. Alanine aminotransferase (ALT) greater than 200 U/L; 6. Acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina, or heart failure (NYHA functional class II or higher), or poorly controlled hypertension (SBP >=160 mmHg and/or diastolic pressure >=100 mmHg), or secondary hypertension (e.g., chronic glomerulonephritis, renal artery stenosis, pheochromocytoma, etc.) within the 3 months prior to enrollment; 7. Abnormal creatinine levels; 8. Severe respiratory diseases affecting physical activity, such as chronic obstructive pulmonary disease (COPD), asthma, etc.; 9. Coexisting diseases affecting dietary therapy, such as severe food allergies, gastrointestinal bleeding, inflammatory bowel disease, chronic bowel obstruction, etc.; 10. History of weight loss surgery or plans to undergo weight loss surgery, or have taken weight loss-related medications in the past month; 11. Alcohol consumption exceeding 7 drinks (15g) per week or alcohol addiction; 12. Female participants who refuse to use contraception during the trial; 13. Patients currently participating in other clinical studies; 14. Failure to sign a written informed consent form; 15. Other reasons deemed unsuitable for clinical research by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Ovulation Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI);Changes in Waist-to-Hip Ratio from Baseline;Hormonal Changes: FSH,LH, PRL, Free Testosterone Levels;oChanges in the Health-Promoting Lifestyle Profile (HPLP-C) from Baseline;oLaboratory Indicators: Red Blood Cell Count, Hemoglobin, White Blood Cell Count, Platelet Count, ALT, AST, Serum Creatinine, Triglycerides, Total Cholesterol, Fasting Blood Glucose;OGTT (Oral Glucose Tolerance Test) and Insulin Resistance-related Indicators; | — |
Countries
China
Contacts
Public ContactFang Xuhong
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed