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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03151005
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
* Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
* Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese \[body mass index (BMI) \>=24 kg/m2 or waistline\>=85cm \].
* All subjects had normal thyroid-stimulating hormone and prolactin levels.
Exclusion Criteria:
* smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
* age below 18 yr or over 50 yr.
* postmenopausal.
* uncontrolled hypertension (blood pressure \>=160/100 mm Hg).
* preexisting OPs or GLP-1 agonists supplementation
* alcohol intake greater than 20 g/d, or pregnancy.
* signs of liver or renal failure or active liver disease (ALT \> 2.5× the upper limit of normal values).
* PLT\<60\*10\^9/L,Hb\<100g/L, smoking, alcohol use.
* The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03151005
Study Brief:
Protocol Section:
NCT03151005