eValuating iDA Selection Ability. The VISA Study.

Study Overview
=================
Brief Summary
-----------------
A non-inferiority, prospective parallel group, multi-center, randomized controlled trial to investigate whether selection of a single blastocyst for transfer using the deep learning tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists using standard morphology criteria.

Official Title
-----------------
Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?

Conditions
-----------------
IVF, Infertility

Intervention / Treatment
-----------------
* Device: iDAScore®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing IVF or ICSI with controlled ovarian stimulation with gonadotrophins and the intention to treat by either transfer of a single fresh embryo on day 5 or in case of a freeze all cycle, the first rewarmed embryo. Age: Up to and including the 42nd completed birthday on the day of randomization. Has at least two early blastocysts on day 5. Exclusion Criteria: Treatment involving donated eggs Intention to perform any form of preimplantation genetic testing The use of IMSI or polarized light in the ICSI process The use of assisted hatching prior to randomization Previous participation in this RCT Where the cycle is carried out for fertility preservation If a day 2-4 transfer is planned Has a reduced likelihood of obtaining two early blastocysts on day 5 as evidenced by either: an AMH level of <3pmol/L or AFC <5 (if available)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Embryo selection by standard morphologic criteria<br>The embryo for transfer will be selected by the embryologist on the basis of the morphologic appearances on day 5, according to the Gardner criteria using the ranking guideline. | |
| Experimental: Embryo selection by iDA<br>Time-lapse videos will be analyzed by iDA and the embryo for fresh transfer on day 5 will be prioritized on the strict basis of the embryo with the highest iDA score. For a frozen cycle; the first embryo to be warmed will be the one with the highest iDA score. | Device: iDAScore®<br>* A system that studies time lapse images obtained from the embryo culture system, Embryoscope, throughout the development to blastocyst. The system uses data acquired from a sequence of embryo images and has taught itself to identify the embryos with the highest likelihood of implanting and leading to fetal heart-beat detection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed | After 7-9 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Defined as the number of patients with at least one live birth after 22 completed weeks of gestation. If the exact gestational age is not known then a birth weight of ≥500gr can be used as a cut-off | 9 months | 
| Positive hCG rate per randomized patient | Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks | Tested on day 9-13 following embryo transfer | 
| Rate of non-viable pregnancies | Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies | After 7-9 weeks of gestation | 
| Ongoing pregnancy rate | Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation | After 7-9 weeks of gestation | 

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