Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

NCT04956848 | Completed

• 1 other identifier: 1571 - KiDA
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

IVF; Infertility

Keywords

Embryos; Embryo scoring; Blastocyst selection; Pregnancy rate; Live birth rate

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

  After 6 weeks of gestation

Secondary Outcomes (3)

• Positive hCG rate per randomized patient

  From day 13 following embryo transfer

• Rate of non-viable intrauterine pregnancies per randomized patient

  After 6 weeks of gestation

• Clinical pregnancy rate in patients with maternal age above 35

  After 6 weeks of gestation

Study Arms (2)

Embryo selection supported by KIDScore™ D5

NO INTERVENTION

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.

Embryo selection supported by iDAScore®

EXPERIMENTAL

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®

Interventions

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.

Embryo selection supported by iDAScore®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vitrolife: lead

Study Sites (2)

Göteborgs IVF klinik

Gothenburg, 412 50, Sweden

Location

Fertilitetsenheten, Universitetssjukhuset Örebro

Örebro, 703 62, Sweden

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Johanna Schmidt, MD

  Göteborgs IVF klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 9, 2021
• Study Start: October 6, 2021
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)