CompletedNot Applicable

eValuating iDA Selection Ability. The VISA Study.

Australia1,066 participantsStarted 2020-02-20

Plain-language summary

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.

Who can participate

SexALL

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Inclusion criteria

✓. 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.
✓. Age: Up to and including the 42nd completed birthday on the day of randomization.
✓. Has at least two early blastocysts on day 5.

Exclusion criteria

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

What they're measuring

Clinical Pregnancy Rate

Timeframe: After 7-9 weeks of gestation

Trial details

NCT IDNCT04969822

SponsorVitrolife

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-24

Results submitted2024-10-03

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