NCT03164551

TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment

A Phase IV, Single-blinded, Prospective, Randomized, Controlled, Multi-center Study to Compare the Clinical Outcomes of Genea Embryo Review Instrument Plus (GERI+) Time Lapse System With a Conventional Embryo Culture and Assessment System

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.

Conditions

• Infertility

Interventions

Type	Name	Description
DEVICE	GERI+ incubator	The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.
DEVICE	Conventional incubator	The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.

Timeline

• Start date: 2018-04-16
• Primary completion: 2019-11-20
• Completion: 2019-11-20
• First posted: 2017-05-23
• Last updated: 2020-12-02
• Results posted: 2020-12-02

Locations

17 sites across 7 countries: Canada, Denmark, France, Italy, Norway, Portugal, Spain