Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

Vitrolife

Status: Completed

Conditions: Infertility; IVF

Treatments: Device: iDAScore®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04956848

1571 - KiDA

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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 5.
2. 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

1. Previous participation in this RCT
2. Concurrent participation in another investigation
3. Intention to perform any form of preimplantation genetic testing
4. Fertility preservation
5. Planned transfer on day 2-4
6. Female age >42 years
7. A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC <5 (if available, AFC=antral follicle count)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 2 patient groups

Embryo selection supported by KIDScore™ D5

No Intervention group

Description:

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®

Experimental group

Description:

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.

Treatment:

Device: iDAScore®