NCT02417441

TiLE (Time Lapse Eeva) Clinical Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 976 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Fertility

Interventions

Type	Name	Description
DEVICE	Eeva	Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.

Timeline

• Start date: 2015-06-29
• Primary completion: 2017-02-09
• Completion: 2017-02-09
• First posted: 2015-04-15
• Last updated: 2020-01-30
• Results posted: 2019-04-29

Locations

23 sites across 9 countries: Canada, Denmark, France, Germany, Italy, Norway, Spain, Sweden, United Kingdom