TiLE (Time Lapse Eeva) Clinical Trial

A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.

Inclusion Criteria:

• All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)
• Subject age less than or equal to (<=) 40 years
• Less than or equal to (<=) 3 failed IVF/ICSI cycles
• At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle
• Normal uterine cavity
• Fertilization using only ejaculated sperm (fresh or frozen)
• Subject must have read and signed the Informed Consent Form

Exclusion Criteria:

• Have clinically significant systemic disease
• Have abnormal, undiagnosed gynecological bleeding
• Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted reproductive technologies (ART) and to gonadotropins to be used in ART
• Egg donor cycle
• Planned "freeze all" cycle (oocytes or embryos)
• Concurrent participation in another clinical trial