eValuating iDA Selection Ability. The VISA Study.

Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?

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.

Study Overview

• Status: Completed
• Conditions: Infertility; IVF
• Intervention / Treatment: Device: iDAScore®

• Study Type: Interventional
• Enrollment (Actual): 1066
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Greenwich
    • Sydney, Greenwich, Australia, 2065
      • IVFAustralia Greenwich
  • New South Wales
    • Alexandria, New South Wales, Australia, 2015
      • IVFAustralia Alexandria
    • Sydney, New South Wales, Australia, 2145
      • IVFAustralia, Westmead
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Queensland Fertility Group (QFG)
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Melbourne IVF
• Denmark
  • Aalborg, Denmark, 9000
    • Universitetshospitalet
  • Aarhus, Denmark, 8200
    • Aagaard Fertilitetsklinik
  • Horsens, Denmark, 8700
    • Regionshospitalet
• Sweden
  • Gothenburg, Sweden, 413 46
    • Reproductive medicine, Sahlgrenska University Hospital
  • Gothenburg, Sweden, 412 55
    • Livio Gothenburg
• United Kingdom
  • Maidenhead, United Kingdom, SL6 4BY
    • Thames Valley Fertility (TFP)
  • Nottingham, United Kingdom, NG10 5QG
    • Nurture Fertility (TFP)
  • Oxford, United Kingdom, OX4 2HW
    • Oxford Fertility (TFP)
  • Southampton, United Kingdom, SO15 5QS
    • Wessex Fertility (TFP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed	After 7-9 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live Birth Rate	Defined as the number of patients with at least one live birth after 22 completed weeks of gestation. If the exact gestational age is not known then a birth weight of ≥500gr can be used as a cut-off	9 months
Positive hCG Rate Per Randomized Patient	Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks	Tested on day 9-13 following embryo transfer
Rate of Non-viable Pregnancies	Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies	After 7-9 weeks of gestation
Ongoing Pregnancy Rate	Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation	After 7-9 weeks of gestation

Collaborators and Investigators

• Sponsor: Vitrolife
• Investigators: Principal Investigator: Peter Illingworth, A/Prof, Virtus Health, Sydney, Australia

Publications and helpful links

General Publications

• 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 Aug 9. doi: 10.1038/s41591-024-03166-5. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): January 24, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy rate; Live birth rate; Embryo; Embryo scoring; Blastocyst selection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 1571 - VISA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No