Infertility, IVF
Conditions
Keywords
Embryos, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate
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.
Interventions
DEVICEiDAScore®
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.
Sponsors
Vitrolife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | After 6 weeks of gestation | Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Sweden
Outcome results
None listed