Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures

Inclusion Criteria:

- Pre-menopausal women aged 18-34 at the time of consent.

- Documentation of a normal uterine cavity by hysteroscopy, hydrosonogram, or
hysterosalpingogram within one year of screening.

- Normal Pap smear test within 24 months of screening.

- At least one cycle without reproductive hormone medication prior to screening
follicle-stimulating hormone (FSH) and estradiol blood draw.

- Tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked
infertility.

Exclusion Criteria:

- Body mass index greater than 38 kg/m^2.

- FSH greater than 15 IU/L during the early follicular phase (Day 2-4). For those
subjects with polycystic ovarian syndrome, a Day 2-4 FSH level can be obtained
following a progestogen withdrawal or spontaneous menses.

- Clinically significant gynecologic pathology, such as submucosal fibroids, intramural
fibroids >5 cm, communicating hydrosalpinx, uncorrected uterine septum, endometrial
cancer or endometrial atypia, scar tissue inside the cavity or poorly developed
uterine lining from prior uterine surgery, pelvic tuberculosis, or any other
conditions that could adversely affect pregnancy success.

- Uncontrolled elevation of prolactin or too little thyroid hormone in the blood.

- History of more than one failed fresh in vitro fertilization cycle. A failed cycle is
defined as having started a cycle and not becoming pregnant or pregnancy loss prior to
the 20th week of pregnancy.