TICON Day -3
Research type
Research Study
Full title
A phase IV, single-blinded, prospective, randomized, controlled, multi-center study to compare the clinical outcomes of GERI+ time lapse system with a conventional embryo culture and assessment system
IRAS ID
228187
Contact name
Luca Sabatini
Contact email
Sponsor organisation
Ergomed plc
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
The purpose of this study is to assess the potential benefit of the medical device (GERI+ system) by comparing the percentage of participants with successful clinical pregnancy between the experimental group (embryos cultured and assessed in the GERI+ system) and control group (embryos cultured in a conventional methods).
The device being used in this study is called the GERI+ system, it comprises of an embryo incubator (with controlled temperature and humidity) which takes images of the embryos every 5 minutes during the culture. This is used together with a diagnostic software called Early Embryo Viability Assessment (EEVA), which analyses the images taken by the incubator, in order assist the embryologist to identify the best embryo/s to implant back into the patient.
Patients undergoing in-vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) at the NHS site where the study is running will be invited to participate.
Participants will be in the study for 10-12 weeks.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1024
Date of REC Opinion
19 Jun 2017
REC opinion
Favourable Opinion