Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

Not Applicable

Completed

• Conditions: IVF; Infertility
• Interventions: Device: iDAScore®

• Registration Number: NCT04956848
• Lead Sponsor: Vitrolife

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-09
• Study Start: 2021-10-06
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embryo selection supported by iDAScore®	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	After 6 weeks of gestation	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary Outcome Measures

Name	Time	Method
Rate of non-viable intrauterine pregnancies per randomized patient	After 6 weeks of gestation	Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed
Clinical pregnancy rate in patients with maternal age above 35	After 6 weeks of gestation	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Positive hCG rate per randomized patient	From day 13 following embryo transfer	An hCG measurement using urinary sticks with a sensitivity of 25 IU/L

Trial Locations

Locations (2)

Göteborgs IVF klinik; 🇸🇪 Göteborg, Sweden

Fertilitetsenheten, Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden