Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

NCT ID: NCT04956848

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2023-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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IVF Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

iDAScore®

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitrolife

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johanna Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Göteborgs IVF klinik

Locations

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Göteborgs IVF klinik

Gothenburg, , Sweden

Site Status

Fertilitetsenheten, Universitetssjukhuset Örebro

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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1571 - KiDA

Identifier Type: -

Identifier Source: org_study_id

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