eValuating iDA Selection Ability. The VISA Study.

Vitrolife

Status: Completed

Conditions: Infertility; IVF

Treatments: Device: iDAScore®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04969822

1571 - VISA

Details and patient eligibility

About

A non-inferiority, prospective parallel group, multi-center, randomized controlled trial to investigate whether selection of a single blastocyst for transfer using the deep learning tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists using standard morphology criteria.

Enrollment: 1,066 patients

Sex: All

Volunteers: No Healthy Volunteers

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

1. Treatment involving donated eggs
2. Intention to perform any form of preimplantation genetic testing
3. The use of IMSI or polarized light in the ICSI process
4. The use of assisted hatching prior to randomization
5. Previous participation in this RCT
6. Where the cycle is carried out for fertility preservation
7. If a day 2-4 transfer is planned
8. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,066 participants in 2 patient groups

Embryo selection by standard morphologic criteria

No Intervention group

Description:

The embryo for transfer will be selected by the embryologist on the basis of the morphologic appearances on day 5, according to the Gardner criteria using the ranking guideline.

Embryo selection by iDA

Experimental group

Description:

Time-lapse videos will be analyzed by iDA and the embryo for fresh transfer on day 5 will be prioritized on the strict basis of the embryo with the highest iDA score. For a frozen cycle; the first embryo to be warmed will be the one with the highest iDA score.

Treatment:

Device: iDAScore®