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eValuating iDA Selection Ability. The VISA Study.

Primary Purpose

IVF, Infertility

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
iDAScore®
Sponsored by
Vitrolife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IVF focused on measuring Embryo, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • IVFAustralia Greenwich
  • IVFAustralia Alexandria
  • IVFAustralia, Westmead
  • Queensland Fertility Group (QFG)
  • Melbourne IVF
  • Universitetshospitalet
  • Aagaard Fertilitetsklinik
  • Regionshospitalet
  • Aish Ahlström
  • Reproductive medicine, Sahlgrenska University Hospital
  • Thames Valley Fertility (TFP)
  • Nurture Fertility (TFP)
  • Oxford Fertility (TFP)
  • Wessex Fertility (TFP)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Embryo selection by standard morphologic criteria

Embryo selection by iDA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary Outcome Measures

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
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
Rate of non-viable pregnancies
Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies
Ongoing pregnancy rate
Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation

Full Information

First Posted
June 30, 2021
Last Updated
June 9, 2023
Sponsor
Vitrolife
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1. Study Identification

Unique Protocol Identification Number
NCT04969822
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
January 24, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitrolife

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Infertility
Keywords
Embryo, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embryo selection by standard morphologic criteria
Arm Type
No Intervention
Arm Description
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.
Arm Title
Embryo selection by iDA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iDAScore®
Intervention Description
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 Measure Information:
Title
Clinical pregnancy rate
Description
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Time Frame
After 7-9 weeks of gestation
Secondary Outcome Measure Information:
Title
Live birth rate
Description
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
Time Frame
9 months
Title
Positive hCG rate per randomized patient
Description
Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks
Time Frame
Tested on day 9-13 following embryo transfer
Title
Rate of non-viable pregnancies
Description
Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies
Time Frame
After 7-9 weeks of gestation
Title
Ongoing pregnancy rate
Description
Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation
Time Frame
After 7-9 weeks of gestation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Illingworth, A/Prof
Organizational Affiliation
Virtus Health, Sydney, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVFAustralia Greenwich
City
Sydney
State/Province
Greenwich
ZIP/Postal Code
2065
Country
Australia
Facility Name
IVFAustralia Alexandria
City
Alexandria
State/Province
New South Wales
ZIP/Postal Code
2015
Country
Australia
Facility Name
IVFAustralia, Westmead
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Queensland Fertility Group (QFG)
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Melbourne IVF
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Universitetshospitalet
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aagaard Fertilitetsklinik
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Regionshospitalet
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Aish Ahlström
City
Gothenburg
ZIP/Postal Code
412 55
Country
Sweden
Facility Name
Reproductive medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Thames Valley Fertility (TFP)
City
Maidenhead
ZIP/Postal Code
SL6 4BY
Country
United Kingdom
Facility Name
Nurture Fertility (TFP)
City
Nottingham
ZIP/Postal Code
NG10 5QG
Country
United Kingdom
Facility Name
Oxford Fertility (TFP)
City
Oxford
ZIP/Postal Code
OX4 2HW
Country
United Kingdom
Facility Name
Wessex Fertility (TFP)
City
Southampton
ZIP/Postal Code
SO15 5QS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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eValuating iDA Selection Ability. The VISA Study.

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