US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

Inclusion Criteria:

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
• IVF cycle attempts ≤ 2.
• Egg age ≤ 40 years.
• Planned Day 3 embryo transfer.
• At least 4 normally fertilized eggs (2PN).
• All 2PN embryos must be imaged by Eeva.
• Ejaculated sperm or sperm from the epididymis (fresh or frozen).
• Willing to comply with study protocol and procedures.
• Willing to provide written informed consent.

Exclusion Criteria:

• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Planned "freeze all" cycle (oocytes or embryos).
• Sperm retrieved from testicular tissue.
• Abnormal uterine cavity as evaluated by standard methods.
• Gestational carrier.
• Endometriosis
• Hydrosalpinx.
• History of cancer.
• Concurrent participation in another clinical study.