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Table 1 Overview of study visits

From: Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial

 

Screening visit

Baseline visit

Monthly visit 1

Monthly visit 2

Monthly visit 3 and end-of-treatment visit

Follow-up visit

Physical exam

X

   

X

X

Safety labs

X

   

X

 

Transvaginal ultrasound

 

X

  

X

X

Fasting phlebotomy for study parameters

 

X

  

X

 

Hyperinsulinemiceuglycemic clamp

 

X

  

X

 

Query for adverse event and concomitant medications

 

X

X

X

X

X

Query for menstrual period

X

X

X

X

X

X

Medication dispensing and accounting

 

X

X

X

  
  1. Physical examination: Height, weight, hip and waist circumference, blood pressure, FG score, acne.
  2. Fasting phlebotomy: Serum for the Central Core Laboratory.
  3. Transvaginal ultrasound: endometrial thickness, ovarian volume, antral follicle count, and size of ovarian cysts or developing follicles.