None listed
Conditions
Brief summary
The project is a randomised controlled trial to evaluate the clinical effects of a deep learning system, (IVY). IVY studies the images of each embryo during culture. Previous work shows that it is a good predictor of which embryo has highest chance of implanting. This project aims to investigate what effects, if any, this has on the success rate from IVF.
Interventions
Selection of an embryo for transfer by artificial intelligence.
a) The intervention will involve use of a deep learning system, iDA, to review time lapse images (every 10 minutes for five days) taken of embryos growing in an incubator. The deep learning system will analyse these images and use a published validated process to identify which embryo has the highest likelihood of successful implantation.
b) The participants will be treated by their doctor as per normal. The embryos will be cul
Selection of an embryo for transfer by artificial intelligence. a) The intervention will involve use of a deep learning system, iDA, to review time lapse images (every 10 minutes for five days) taken of embryos growing in an incubator. The deep learning system will analyse these images and use a published validated process to identify which embryo has the highest likelihood of successful implantation. b) The participants will be treated by their doctor as per normal. The embryos will be cultured as per normal. The only change for the participants will be which embryo is selected FIRST for transfer. c) The intervention will be implemented by the embryologist following randomisation. d) The artificial intelligence system is built into the incubators e) The intervention will be delivered once on Day 5 of embryo culture and will direct which embryo is transferred that morning. f) The software will be locked to ensure that the embryologist will not be able to implement the deep learning system unless the participant is randomised to use of iDA for embryo selection. All randomisation will be done through an electronic CRF which will monitor and record all randomisations.
Sponsors
Vitrolife
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
21 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria 1) Women undergoing IVF or ICSI with controlled ovarian stimulation with gonadotrophins and the intention to treat by either transfer of a single fresh embryo on Day 5 or in case of a freeze all cycle, the first rewarmed embryo. 2) Age: Up to and including the 42nd completed birthday on the day of randomization. 3) Has at least two early blastocysts on Day 5
Exclusion criteria
Exclusion Criteria 1) Treatment involving donated eggs 2) Intention to perform any form of preimplantation genetic testing 3) IMSI patients 4) Previous participation in this RCT 5) Where the cycle is carried out for fertility preservation. 6) If a Day 2-4 transfer is planned 7) Has a reduced likelihood of obtaining two early blastocysts on day 5 as evidenced by either: • An AMH level of <3pmol/L or AFC <5 (if available)
Outcome results
None listed