Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06666933
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
38 Years
Study:
NCT06666933
Study Brief:
Protocol Section:
NCT06666933