Table 3.
Overview of the study visits
| Screening visit | Baseline visit | Treatment visits (16 weeks) | End-of-treatment visit | Pregnancy visit | ||||
|---|---|---|---|---|---|---|---|---|
| Personalized acupuncture | Fixed acupuncture | Letrozole | Placebo letrozole | |||||
| 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