406
Participants
Start Date
September 15, 2023
Primary Completion Date
January 1, 2026
Study Completion Date
March 31, 2026
CRD
During the initial 8 weeks of the trial, polycystic ovary syndrome (PCOS) patients are instructed to follow a diet of 1200 to 1500 kcal per day supervised by dietitians. The CRD includes a combination of 40 to 55% of calories from carbohydrates, 15 to 20% from protein, and 20 to 30% from fat; this regimen represented approximately 75% of the participants' daily caloric intake at baseline. All the participants receive dietary counseling daily during the trial.
Metformin
After randomization, patients entering the metformin group will be given 1500 mg daily (bid/tid) metformin and regular diets as control. Participants allocated to the control group are followed by the conventional approach (usual care) based on regular visits respecting the usual schedule dictated by the rules of general practice.
RECRUITING
Shanghai First Maternity and Infant Hospital, Shanghai
RenJi Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Shanghai First Maternity and Infant Hospital
OTHER