eValuating iDA Selection Ability. The VISA Study.

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04969822
• Other study ID #: 1571 - VISA
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Vitrolife
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1040
• Est. completion date: December 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

Device:
• iDAScore®
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.

Locations

Country	Name	City	State
Australia	IVFAustralia Alexandria	Alexandria	New South Wales
Australia	Queensland Fertility Group (QFG)	Benowa	Queensland
Australia	Melbourne IVF	East Melbourne	Victoria
Australia	IVFAustralia Greenwich	Sydney	Greenwich
Australia	IVFAustralia, Westmead	Sydney	New South Wales
Denmark	Universitetshospitalet	Aalborg
Denmark	Aagaard Fertilitetsklinik	Aarhus
Denmark	Regionshospitalet	Horsens
Sweden	Aish Ahlström	Gothenburg
Sweden	Reproductive medicine, Sahlgrenska University Hospital	Gothenburg
United Kingdom	Thames Valley Fertility (TFP)	Maidenhead
United Kingdom	Nurture Fertility (TFP)	Nottingham
United Kingdom	Oxford Fertility (TFP)	Oxford
United Kingdom	Wessex Fertility (TFP)	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Vitrolife

Countries where clinical trial is conducted

Australia,  Denmark,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed	After 7-9 weeks of gestation
Secondary	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
Secondary	Positive hCG rate per randomized patient	Defined as the number of patients with a positive ß-hCG, determined by a hCG measurement from a blood sample or using urinary sticks	Tested on day 9-13 following embryo transfer
Secondary	Rate of non-viable pregnancies	Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive ß-hCG pregnancies	After 7-9 weeks of gestation
Secondary	Ongoing pregnancy rate	Defined as the number of patients with a viable pregnancy at =12 weeks of gestation	After 7-9 weeks of gestation