Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

Study Overview
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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.

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

Conditions
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IVF, Infertility

Intervention / Treatment
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* Device: iDAScore®


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Embryo selection supported by KIDScore™ D5<br>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®<br>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®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryos, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate