N/A
N=1,066
eValuating iDA Selection Ability. The VISA Study.
IVF · Infertility
Bottom Line
View on ClinicalTrials.gov: NCT04969822 ↗Enrolled (actual)
1,066
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Clinical Pregnancy Rate — 257; 248 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iDAScore® (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Vitrolife
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pregnancy Rate |
257; 248 | — |
| SECONDARY Live Birth Rate |
232; 212 | — |
| SECONDARY Positive hCG Rate Per Randomized Patient |
303; 297 | — |
| SECONDARY Rate of Non-viable Pregnancies |
46; 49 | — |
| SECONDARY Ongoing Pregnancy Rate |
241; 229 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04969822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.