Comparing KIDScore™ D5 and iDAScore®. The KiDA Study

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956848
• Other study ID #: 1571 - KiDA
• Status: Completed
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: November 14, 2023

Study information

• Verified date: March 2024
• Source: Vitrolife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	Göteborgs IVF klinik	Göteborg
Sweden	Fertilitetsenheten, Universitetssjukhuset Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Vitrolife

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed	After 6 weeks of gestation
Secondary	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
Secondary	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
Secondary	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