Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
1066 participants
INTERVENTIONAL
2020-02-20
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Embryo selection by standard morphologic criteria
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.
No interventions assigned to this group
Embryo selection by iDA
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.
iDAScore®
A system that studies time lapse images obtained from the embryo culture system, Embryoscope, throughout the development to blastocyst. The system uses data acquired from a sequence of embryo images and has taught itself to identify the embryos with the highest likelihood of implanting and leading to fetal heart-beat detection.
Interventions
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iDAScore®
A system that studies time lapse images obtained from the embryo culture system, Embryoscope, throughout the development to blastocyst. The system uses data acquired from a sequence of embryo images and has taught itself to identify the embryos with the highest likelihood of implanting and leading to fetal heart-beat detection.
Eligibility Criteria
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Inclusion Criteria
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
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)
ALL
No
Sponsors
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Vitrolife
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Illingworth, A/Prof
Role: PRINCIPAL_INVESTIGATOR
Virtus Health, Sydney, Australia
Locations
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IVFAustralia Greenwich
Sydney, Greenwich, Australia
IVFAustralia Alexandria
Alexandria, New South Wales, Australia
IVFAustralia, Westmead
Sydney, New South Wales, Australia
Queensland Fertility Group (QFG)
Benowa, Queensland, Australia
Melbourne IVF
East Melbourne, Victoria, Australia
Universitetshospitalet
Aalborg, , Denmark
Aagaard Fertilitetsklinik
Aarhus, , Denmark
Regionshospitalet
Horsens, , Denmark
Livio Gothenburg
Gothenburg, , Sweden
Reproductive medicine, Sahlgrenska University Hospital
Gothenburg, , Sweden
Thames Valley Fertility (TFP)
Maidenhead, , United Kingdom
Nurture Fertility (TFP)
Nottingham, , United Kingdom
Oxford Fertility (TFP)
Oxford, , United Kingdom
Wessex Fertility (TFP)
Southampton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1571 - VISA
Identifier Type: -
Identifier Source: org_study_id