Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

Table 2

Overview of the study visits.

	Screening visit	Baseline visit	Week 1		Week 2		Week 𝑁+1		Week 16		End of treatment visit
Visit #	1	2	3	4	5	6	𝑁	𝑁+1	33	34	35
Sign consent	×
History	×										×
Urine pregnancy test	×		×	×	×	×	×	×	×	×
Physical examination	×										×
Transvaginal ultrasound	×										×
Semen analysis	×
Hysterosalpingogram	×
Safety eligibility lads	×										×
Fasting phlebotomy for study parameters		×									×
Depression, anxiety, and quality of life questionnaires	×										×
Credibility check questionnaire			×		×						×
Progesterone assay	×			×		×		×		×	×
HCG assay	×			×		×		×		×	×
Acupuncture treatments (twice weekly)			×	×	×	×	×	×	×	×
Assess adverse events and concomitant meds				×		×		×		×	×

Credibility check questionnaires are completed on the third acupuncture treatment and the last acupuncture treatment.
HCG: HCG concentrations will be measured once a week during the study period. If serum HCG concentration is elevated above 10 IU/L, pelvic ultrasound will be arranged 2 weeks later for the number of the gestational sacs and the viability of the pregnancy.