Study of Time-restricted Eating (TRE) to Clinical Pregnancy Rate in PCOS Women With Glucose Metabolism Disorder Via IVF/ICSI

Launched by RENJI HOSPITAL · Oct 28, 2024

Keywords

ClinConnect Summary

In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI.

Investigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every parti...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed with PCOS based on Rotterdam 2003 (all 3 criteria should be fulfilled);
• • 2. Diagnosed with glucose metabolism disorder (IGT, IFG, IGT with IFG, T2DM) and HbA1c less than or equal to 7%;
• • 3. Age 20-38;
• • 4. Overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2);
• • 5. Indication for IVF/ ICSI (repeated ovarian stimulation failure/ Fallopian tube blockage/ male factor) and ready for the 1st/ 2nd cycle of IVF;
• • 6. Cooperative to follow-ups and capable of reporting severe adverse event (SAE);
• • 7. Completed informed consent.
• Exclusion Criteria:
• • 1. Unilateral ovary resection;
• • 2. Abnormal uterus cavity (congenital, chronic endometrium inflammation, polyps, adhesion, fibroids, etc);
• • 3. Chromosomal abnormality (either maternal or paternal);
• • 4. Recurrent abortion or recurrent failure of embryo transfer;
• • 5. Metformin allergy/ intolerance;
• • 6. Other serious or uncontrolled diseases (e.g. kidney insufficiency, infection, controlled hypertension, heart disease, etc);
• • 7. Preimplantation genetic testing;
• • 8. Other condition that may impact the results