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Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

Primary Purpose

IVF, Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
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 Embryos, 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. 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)

Sites / Locations

  • Göteborgs IVF klinikRecruiting
  • Fertilitetsenheten, Universitetssjukhuset ÖrebroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Embryo selection supported by KIDScore™ D5

Embryo selection supported by iDAScore®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Positive hCG rate per randomized patient
An hCG measurement using urinary sticks with a sensitivity of 25 IU/L
Rate of non-viable intrauterine pregnancies per randomized patient
Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed
Clinical pregnancy rate in patients with maternal age above 35
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Full Information

First Posted
June 30, 2021
Last Updated
September 28, 2022
Sponsor
Vitrolife
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1. Study Identification

Unique Protocol Identification Number
NCT04956848
Brief Title
Comparing KIDScore™ D5 and iDAScore®. The KiDA Study
Official Title
A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (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
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Embryo selection supported by KIDScore™ D5
Arm Type
No Intervention
Arm Description
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.
Arm Title
Embryo selection supported by iDAScore®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
iDAScore®
Intervention Description
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 Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Time Frame
After 6 weeks of gestation
Secondary Outcome Measure Information:
Title
Positive hCG rate per randomized patient
Description
An hCG measurement using urinary sticks with a sensitivity of 25 IU/L
Time Frame
From day 13 following embryo transfer
Title
Rate of non-viable intrauterine pregnancies per randomized patient
Description
Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed
Time Frame
After 6 weeks of gestation
Title
Clinical pregnancy rate in patients with maternal age above 35
Description
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Time Frame
After 6 weeks of gestation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thorir Hardarson, PhD
Phone
+46708228063
Email
thardarson@vitrolife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Schmidt, MD
Organizational Affiliation
Göteborgs IVF klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Göteborgs IVF klinik
City
Göteborg
ZIP/Postal Code
412 50
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Schmidt, MD
Facility Name
Fertilitetsenheten, Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Bohlin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

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