TiLE – Time Lapse Eeva™
Research type
Research Study
Full title
A Phase IV, prospective, randomized, exploratory, multicenter, Eeva™ trial
IRAS ID
178341
Contact name
Sergio A Fonseca
Contact email
Sponsor organisation
Merck KGaA
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Eeva™ (Early Embryo Viability Assessment) is a time lapse monitoring system with integrated software, which takes photos of embryos every five minutes during embryo culture and development. The high quality images collected are automatically analysed and validated by the software to define precise timing of cell divisions and make a recommendation that is provided to the user (embryologists at the fertility clinics) to determine the likelihood of whether or not an embryo will develop to the blastocyst stage. This research is being performed to assess embryo viability by collecting real life data and comparing it with a control. The trial will record the use of the device, per the approved CE mark labelling, to gather additional data to evaluate the efficacy to predict embryo implantation potential when combined with morphological assessments. The rate of implantation of transferred embryos selected using the recommendation from Eeva™ plus morphology grading, versus transferred embryos selected using the morphology grading only (control), will be assessed. The data collected will be used for future development of Eeva™ to improve the overall performance of the device. Eligible subjects will be patients undergoing IVF/ICSI treatment cycles at the investigators’ clinics. Subjects’ IVF/ICSI treatments will follow the standard protocol at the sites and will not be altered because of the trial. Embryos will be observed until they are transferred and then subjects’ outcomes information will be collected until implantation and pregnancy are verified.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1159
Date of REC Opinion
4 Sep 2015
REC opinion
Further Information Favourable Opinion