A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vitrolife
- Enrollment
- 165
- Locations
- 4
- Primary Endpoint
- Clinical pregnancy rate
Study Overview
Brief Summary
A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day
- •At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).
Exclusion Criteria
- •Previous participation in this RCT
- •Concurrent participation in another investigation
- •Intention to perform any form of preimplantation genetic testing
- •Fertility preservation
- •Planned transfer on day 2-4
- •Female age >42 years
- •A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC <5 (if available, AFC=antral follicle count)
Arms & Interventions
Embryo selection supported by KIDScore™ D5
Each embryo reaching at least developmental stage of 3BB will annotated by an embryologist using the parameters required by the KIDScore™ D5. The embryo with the highest KIDScore™ will be selected proposed for transfer.
Embryo selection supported by iDAScore®
Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed selected for transfer.
Intervention: iDAScore® (Device)
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: After 6 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Secondary Outcomes
- Rate of non-viable intrauterine pregnancies per randomized patient(After 6 weeks of gestation)
- Clinical pregnancy rate in patients with maternal age above 35(After 6 weeks of gestation)
- Positive hCG rate per randomized patient(From day 13 following embryo transfer)