Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

March 8, 2024 updated by: Vitrolife

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 412 50
        • Göteborgs IVF klinik
      • Örebro, Sweden, 703 62
        • Fertilitetsenheten, Universitetssjukhuset Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Embryo selection supported by KIDScore™ D5
Each embryo reaching at least developmental stage of 3BB will annotated by an embryologist using the parameters required by the KIDScore™ D5. The embryo with the highest KIDScore™ will be selected proposed for transfer.
Experimental: Embryo selection supported by iDAScore®
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 selected for transfer.
Device: iDAScore®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: After 6 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
After 6 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From day 13 following embryo transfer
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
After 6 weeks of gestation
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
After 6 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitrolife

Investigators

  • Principal Investigator: Johanna Schmidt, MD, Göteborgs IVF klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Actual)

November 14, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1571 - KiDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on iDAScore®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe