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.