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OpenTrials
Completed

NCT Number: NCT04969822

eValuating iDA Selection Ability. The VISA Study.

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.

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Key information

Conditions

IVF Genital Diseases Infertility Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IVFAustralia Greenwich, Sydney, Greenwich, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: After 7-9 weeks of gestation

    Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary outcomes

  1. Live Birth Rate

    Time frame: 9 months

    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

  2. Positive hCG Rate Per Randomized Patient

    Time frame: Tested on day 9-13 following embryo transfer

    Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks

  3. Rate of Non-viable Pregnancies

    Time frame: After 7-9 weeks of gestation

    Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies

  4. Ongoing Pregnancy Rate

    Time frame: After 7-9 weeks of gestation

    Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation

Sponsors and collaborators

Lead sponsor

Vitrolife

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2021
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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