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eValuating iDA Selection Ability. The VISA Study.

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ClinicalTrials.gov Identifier: NCT04969822
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Vitrolife

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 an equally as high clinical pregnancy rate compared to trained embryologists using standard morphology criteria.

Condition or disease Intervention/treatment Phase
IVF Infertility Device: iDAScore® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

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.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: After 7-9 weeks of gestation ]
    Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed


Secondary Outcome Measures :
  1. Live birth rate [ Time Frame: 9 months ]
    Birth of a living child

  2. Positive hCG rate per randomized patient [ Time Frame: Tested on day 9-13 following embryo transfer ]
    An hCG measurement using urinary sticks with a sensitivity of 25 IU/L

  3. Rate of non-viable intrauterine pregnancies [ Time Frame: After 7-9 weeks of gestation ]
    Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed

  4. Ongoing pregnancy rate in patients with maternal age above 35 [ Time Frame: After 7-9 weeks of gestation ]
    Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969822


Contacts
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Contact: Thorir Hardarson, PhD +46708228063 thardarson@vitrolife.com

Locations
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Australia, Greenwich
IVFAustralia Greenwich Recruiting
Sydney, Greenwich, Australia, 2065
Australia, New South Wales
IVFAustralia Alexandria Recruiting
Alexandria, New South Wales, Australia, 2015
IVFAustralia, Westmead Recruiting
Sydney, New South Wales, Australia, 2145
Contact: David Gardner, Prof.         
Australia, Queensland
Queensland Fertility Group (QFG) Recruiting
Benowa, Queensland, Australia, 4217
Australia, Victoria
Melbourne IVF Recruiting
East Melbourne, Victoria, Australia, 3002
Denmark
Aagaard Fertilitetsklinik Recruiting
Aarhus, Denmark, 8200
VivaNeo Stork Fertilitetsklinik Not yet recruiting
Copenhagen, Denmark, 1264
Hungary
Semmelweis University Not yet recruiting
Budapest, Hungary, 1088
Sweden
Livio Fertilitetscentrum Not yet recruiting
Gothenburg, Sweden, 412 55
Reproductive medicine, Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden, 413 46
United Kingdom
Thames Valley Fertility (TFP) Not yet recruiting
Maidenhead, United Kingdom, SL6 4BY
Nurture Fertility (TFP) Not yet recruiting
Nottingham, United Kingdom, NG10 5QG
Oxford Fertility (TFP) Not yet recruiting
Oxford, United Kingdom, OX4 2HW
Wessex Fertility (TFP) Not yet recruiting
Southampton, United Kingdom, SO15 5QS
Sponsors and Collaborators
Vitrolife
Investigators
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Principal Investigator: Peter Illingworth, A/Prof Virtus Health, Sydney, Australia
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Responsible Party: Vitrolife
ClinicalTrials.gov Identifier: NCT04969822    
Other Study ID Numbers: 1571 - VISA
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitrolife:
Embryo
Embryo scoring
Blastocyst selection
Pregnancy rate
Live birth rate
Additional relevant MeSH terms:
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Infertility