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OpenTrials
Completed

NCT Number: NCT04956848

Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.

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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

Göteborgs IVF klinik, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day 5.
  • At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).

Exclusion criteria

  • Previous participation in this RCT
  • Concurrent participation in another investigation
  • Intention to perform any form of preimplantation genetic testing
  • Fertility preservation
  • Planned transfer on day 2-4
  • Female age >42 years
  • A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC <5 (if available, AFC=antral follicle count)

Treatment and study plan

iDAScore®

Device

Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed for transfer.

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: After 6 weeks of gestation

    Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary outcomes

  1. Positive hCG rate per randomized patient

    Time frame: From day 13 following embryo transfer

    An hCG measurement using urinary sticks with a sensitivity of 25 IU/L

  2. Rate of non-viable intrauterine pregnancies per randomized patient

    Time frame: After 6 weeks of gestation

    Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed

  3. Clinical pregnancy rate in patients with maternal age above 35

    Time frame: After 6 weeks of gestation

    Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Sponsors and collaborators

Lead sponsor

Vitrolife

Industry

Registry information

Official study title

A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2021
Registry last updated
Mar 12, 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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