eValuating iDA Selection Ability. The VISA Study.

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Embryo selection by iDA	iDAScore®	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.

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	After 7-9 weeks of gestation	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Secondary Outcome Measures

Name	Time	Method
Live Birth Rate	9 months	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
Positive hCG Rate Per Randomized Patient	Tested on day 9-13 following embryo transfer	Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks
Rate of Non-viable Pregnancies	After 7-9 weeks of gestation	Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies
Ongoing Pregnancy Rate	After 7-9 weeks of gestation	Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation

Locations (14): Livio Gothenburg
🇸🇪
Gothenburg, Sweden
IVFAustralia Greenwich
🇦🇺
Sydney, Greenwich, Australia
IVFAustralia Alexandria
🇦🇺
Alexandria, New South Wales, Australia
IVFAustralia, Westmead
🇦🇺
Sydney, New South Wales, Australia
Queensland Fertility Group (QFG)
🇦🇺
Benowa, Queensland, Australia
Melbourne IVF
🇦🇺
East Melbourne, Victoria, Australia
Universitetshospitalet
🇩🇰
Aalborg, Denmark
Aagaard Fertilitetsklinik
🇩🇰
Aarhus, Denmark
Regionshospitalet
🇩🇰
Horsens, Denmark
Reproductive medicine, Sahlgrenska University Hospital
🇸🇪
Gothenburg, Sweden
Thames Valley Fertility (TFP)
🇬🇧
Maidenhead, United Kingdom
Nurture Fertility (TFP)
🇬🇧
Nottingham, United Kingdom
Oxford Fertility (TFP)
🇬🇧
Oxford, United Kingdom
Wessex Fertility (TFP)
🇬🇧
Southampton, United Kingdom