Eeva 12-well Dish Study

Eeva 12-well Dish Study

The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.

This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians

Inclusion Criteria:

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
• Subject is at least 18 years of age.
• Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
• Subjects has basal FSH < 11 IU
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Subject has at least 8 normally fertilized eggs (2PN)
• Willing to have all 2PN embryos monitored by Eeva
• Willing to comply with study protocol and procedures and able to speak English.
• Willing to provide written informed consent.

Exclusion Criteria:

• Reinseminated eggs.
• History of cancer.
• Gestational carriers.
• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Previously enrolled in this study
• Concurrent participation in another clinical study.
• Any other reason the Investigator believes the subject should not participate in the clinical study.