eValuating iDA Selection Ability. The VISA Study.

NCT04969822 | Completed Results DMC

• 1 other identifier: 1571 - VISA
• Study Type: interventional
• Target: 1,066
• Locations: 4 countries
• Sites: 14

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.

Conditions

IVF; Infertility

Keywords

Embryo; Embryo scoring; Blastocyst selection; Pregnancy rate; Live birth rate

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

  After 7-9 weeks of gestation

Secondary Outcomes (4)

• Live Birth Rate

  9 months

• Positive hCG Rate Per Randomized Patient

  Tested on day 9-13 following embryo transfer

• Rate of Non-viable Pregnancies

  After 7-9 weeks of gestation

• Ongoing Pregnancy Rate

  After 7-9 weeks of gestation

Study Arms (2)

Embryo selection by standard morphologic criteria

NO INTERVENTION

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.

Embryo selection by iDA

EXPERIMENTAL

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®

Interventions

iDAScore® DEVICE

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.

Embryo selection by iDA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vitrolife: lead

Study Sites (14)

IVFAustralia Greenwich

Sydney, Greenwich, 2065, Australia

Location

IVFAustralia Alexandria

Alexandria, New South Wales, 2015, Australia

Location

IVFAustralia, Westmead

Sydney, New South Wales, 2145, Australia

Location

Queensland Fertility Group (QFG)

Benowa, Queensland, 4217, Australia

Location

Melbourne IVF

East Melbourne, Victoria, 3002, Australia

Location

Universitetshospitalet

Aalborg, 9000, Denmark

Location

Aagaard Fertilitetsklinik

Aarhus, 8200, Denmark

Location

Regionshospitalet

Horsens, 8700, Denmark

Location

Livio Gothenburg

Gothenburg, 412 55, Sweden

Location

Reproductive medicine, Sahlgrenska University Hospital

Gothenburg, 413 46, Sweden

Location

Thames Valley Fertility (TFP)

Maidenhead, SL6 4BY, United Kingdom

Location

Nurture Fertility (TFP)

Nottingham, NG10 5QG, United Kingdom

Location

Oxford Fertility (TFP)

Oxford, OX4 2HW, United Kingdom

Location

Wessex Fertility (TFP)

Southampton, SO15 5QS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39122964 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

The time-to-pregnancy and cumulative live birth rates were not assessed, as only the first embryo was prioritized for transfer.

Results Point of Contact

• Title: Mr. Jørgen Berntsen
• Organization: Vitrolife A/S

jberntsen@vitrolife.com

+4551542005

Study Officials

• Peter Illingworth, A/Prof

  Virtus Health, Sydney, Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 21, 2021
• Study Start: February 20, 2020
• Primary Completion: January 24, 2023
• Study Completion: November 1, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); DK (3); SE (2); AU (5)