A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome

Table 3 Overview of the study visits

	Screening visit	Baseline visit	Treatment visits (16 weeks)				End-of-treatment visit	Pregnancy visit
	Screening visit	Baseline visit	Personalized acupuncture	Fixed acupuncture	Letrozole	Placebo letrozole	End-of-treatment visit	Pregnancy visit
Sign consent	×
History	×						×
Urine pregnancy test	×	×	×	×	×	×
Physical examination	×						×
Transvaginal ultrasound	×							×
Semen analysis	×
Tubal patency test	×
HPV or TCT	×
Preconception counseling	×
Fasting blood for laboratory tests	×						×
Blood sample collection		×					×
Serum progesterone assay	×		×	×	×	×		×
Serum HCG assay	×	×	×	×	×	×		×
Questionnaires		×					×
Acupuncture treatment (three times weekly)			×	×
Assess adverse events and concomitant medications			×	×	×	×	×	×
Pregnancy and neonatal records								×

Physical examination: weight, height, waist circumference, hip circumference, Ferriman-Gallwey/acne
Fasting blood for laboratory test: follicle-stimulating hormone, luteinizing hormone, sex hormone–binding globulin, total testosterone, free testosterone, estradiol, prolactin, fasting blood glucose, fasting insulin, C-peptide, glycated hemoglobin, cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, complete blood count, thyroid profile, renal profile, and liver profile
Transvaginal ultrasound: endometrial thickness, ovarian volume, antral follicle count, and size of ovarian cysts or developing follicles
Preconception counseling: TORCH (toxoplasmosis, rubella, cytomegalovirus, and herpesvirus) and human immunodeficiency virus screening
Blood sample collection: serum for the central core laboratory
Abbreviations: HCG Human chorionic gonadotropin, HPV Human papillomavirus, TCT ThinPrep cytologic test

ISSN: 1745-6215