eValuating iDA Selection Ability. The VISA Study.

Vitrolife1,066 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,066

Conditions

IVF Infertility

Interventions

iDAScore®DEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Age: Up to and including the 42nd completed birthday on the day of randomization. 3. Has at least two early blastocysts on day 5. Exclusion Criteria: 1. Treatment involving donated eggs 2. Intention to perform any form of preimplantation genetic testing 3. The use of IMSI or polarized light in the ICSI process 4. The use of assisted hatching prior to randomization 5. Previous participation in this RCT 6. Where the cycle is carried out for fertility preservation 7. If a day 2-4 transfer is planned 8. 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)

Locations (14)

IVFAustralia Greenwich

Sydney, Greenwich, Australia

IVFAustralia Alexandria

Alexandria, New South Wales, Australia

IVFAustralia, Westmead

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Clinical Pregnancy Rate

Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Time frame: After 7-9 weeks of gestation

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: After 7-9 weeks of gestation

Ongoing Pregnancy Rate

Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation

Time frame: After 7-9 weeks of gestation

Data from ClinicalTrials.gov

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