Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

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

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Inclusion Criteria:

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
• IVF cycle attempts ≤ 3.
• Egg age ≤ 40 years.
• Planned Day 3 embryo transfer.
• At least 5 normally fertilized eggs (2PN).
• All 2PN embryos must be imaged by Eeva.
• Normal uterine cavity as evaluated by standard methods.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Willing to comply with study protocol and procedures.
• Willing to provide written informed consent.

Exclusion Criteria:

• Planned preimplantation genetic diagnosis.
• Planned "freeze all" cycle (oocytes or embryos).
• Concurrent participation in another clinical study.