CRD vs. Met in Patients With Obese PCOS Infertility

NARecruitingINTERVENTIONAL
Enrollment

406

Participants

Timeline

Start Date

September 15, 2023

Primary Completion Date

January 1, 2026

Study Completion Date

March 31, 2026

Conditions
Polycystic Ovary Syndrome
Interventions
BEHAVIORAL

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.

DRUG

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.

Trial Locations (1)

201204

RECRUITING

Shanghai First Maternity and Infant Hospital, Shanghai

All Listed Sponsors
collaborator

RenJi Hospital

OTHER

collaborator

Shanghai 10th People's Hospital

OTHER

lead

Shanghai First Maternity and Infant Hospital

OTHER