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:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT06519656
Eligibility Criteria:
Inclusion Criteria:
* BMI≥28kg/M2
* No plan for pregnancy in the coming 8 months after enrollment
* Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :
1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle
2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound
3. Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4
Exclusion Criteria:
* Previous history of acute or chronic pancreatitis or pancreatic injury
* Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
* Severe hypertriglyceridemia (TG\>5mmol/L)
* Type 1 or type 2 diabetes mellitus
* Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
* Pregnancy or breast-feeding
* Patients with other serious diseases affecting heart, liver, kidney, or other major organs
* Patients with any type of cancer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06519656
Study Brief:
Protocol Section:
NCT06519656