Table 1 Data collection and procedures by visit

Informed consent

X

Eligibility determination

X

Demographics

X

Medical, reproductive, and obstetric history

X

Medication reconciliation

X

X

X

X

X

X

Vital signs

X

X

X

Physical exam

X

PAP smear will be recommended to be done with gynecologist if not done according to ACOG guidelines

X

Ultrasound (transvaginal while at study site)

X

X

X

X

Estradiol medication self-administration (programmed cycle only)

X

X

X

hCG self-administration (medication to trigger ovulation)

X

Progesterone medication self-administration

X

X

X

X

Embryo transfer

X

X

Questionnaires

X

X

Randomization

X

Adverse event monitoring

X

X

X

X

X

Medical record release

X

Pregnancy data collection

X

Delivery data collection

X

Neonatal data collection

X

Blood and urine samples for banking at study site (baseline scan of first cycle, 6–8 weeks pregnancy visit)

X

X

X

Blood draw(s) for hormone levels used in cycle monitoring

X

X

Optional specimen collection at study site

X