Clinical trial NCT04969822: eValuating iDA Selection Ability. The VISA Study.
Official title: Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
Infertility
Keywords: Embryo
Embryo scoring
Blastocyst selection
Pregnancy rate
Live birth rate
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 1066
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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)

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: After 7-9 weeks of gestation
Secondary outcomes:
measure: Live Birth Rate
timeFrame: 9 months
measure: Positive hCG Rate Per Randomized Patient
timeFrame: Tested on day 9-13 following embryo transfer
measure: Rate of Non-viable Pregnancies
timeFrame: After 7-9 weeks of gestation
measure: Ongoing Pregnancy Rate
timeFrame: After 7-9 weeks of gestation
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: IVFAustralia Greenwich
state: Greenwich
city: Alexandria
country: Australia
facility: IVFAustralia Alexandria
state: New South Wales
city: Sydney
country: Australia
facility: IVFAustralia, Westmead
state: New South Wales
city: Benowa
country: Australia
facility: Queensland Fertility Group (QFG)
state: Queensland
city: East Melbourne
country: Australia
facility: Melbourne IVF
state: Victoria
city: Aalborg
country: Denmark
facility: Universitetshospitalet
city: Aarhus
country: Denmark
facility: Aagaard Fertilitetsklinik
city: Horsens
country: Denmark
facility: Regionshospitalet
city: Gothenburg
country: Sweden
facility: Livio Gothenburg
city: Gothenburg
country: Sweden
facility: Reproductive medicine, Sahlgrenska University Hospital
city: Maidenhead
country: United Kingdom
facility: Thames Valley Fertility (TFP)
city: Nottingham
country: United Kingdom
facility: Nurture Fertility (TFP)
city: Oxford
country: United Kingdom
facility: Oxford Fertility (TFP)
city: Southampton
country: United Kingdom
facility: Wessex Fertility (TFP)
Study officials:
affiliation: Virtus Health, Sydney, Australia
name: Peter Illingworth, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Illingworth PJ, Venetis C, Gardner DK, Nelson SM, Berntsen J, Larman MG, Agresta F, Ahitan S, Ahlstrom A, Cattrall F, Cooke S, Demmers K, Gabrielsen A, Hindkjaer J, Kelley RL, Knight C, Lee L, Lahoud R, Mangat M, Park H, Price A, Trew G, Troest B, Vincent A, Wennerstrom S, Zujovic L, Hardarson T. Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial. Nat Med. 2024 Nov;30(11):3114-3120. doi: 10.1038/s41591-024-03166-5. Epub 2024 Aug 9.