Table 1.
Patient demographics and baseline characteristics, ITT population
| Parameter | PVI | PIO |
|---|---|---|
| (n = 53) | (n = 57) | |
| Age, y | 30.9 (20–40) | 31.5 (22–41) |
| BMI, kg/m2 | 26.9 (5.2) | 28.9 (6.5) |
| Race | ||
| White | 38 (71.7) | 43 (75.4) |
| Black | 0 | 1 (1.8) |
| Asian | 9 (17.0) | 2 (3.5) |
| Hispanic | 6 (11.3) | 10 (17.5) |
| Other | 0 | 1 (1.8) |
| Duration of infertility, months | 32.2 (19.7) | 49.6 (44.6) |
| 26.0 (10–96) | 34.0 (12–240) | |
| ART History | ||
| Number previous IVF cycles | 0.2 (0.5) | 0.2 (0.4) |
| Number failed IVF cycles | 0.1 (0.3) | 0.1 (0.3) |
| Number previous ovulation induction cycles* | 4.2 (3.1) | 5.3 (6.8) |
| Number failed ovulation induction cycles† | 4.1 (3.1) | 5.2 (6.8) |
| Gonadotropin for ovulation induction | ||
| rFSH | 28 (52.8) | 30 (52.6) |
| HP-hMG | 25 (47.2) | 27 (47.4) |
Values are n (%), median (range), or means (standard deviation).
*Excluding IVF, gamete intrafallopian transfer, and/or pronuclear stage embryo transfer.
†Excluding IVF.
ITT, intent to treat; PVI, progesterone vaginal insert; PIO, progesterone in oil; BMI, body mass index; ART, assisted reproductive technologies; rFSH, recombinant follicle-stimulating hormone; HP-hMG, highly purified human menopausal gonadotropin.