Trial Outcomes & Findings for eValuating iDA Selection Ability. The VISA Study. (NCT NCT04969822)

Results Overview

Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1066 participants

Primary outcome timeframe

After 7-9 weeks of gestation

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Embryo Selection by Standard Morphologic Criteria 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.	Embryo Selection by iDA 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. 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.
Overall Study STARTED	533	533
Overall Study COMPLETED	533	533
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.	Total n=1066 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 3.7 • n=533 Participants	33.8 years STANDARD_DEVIATION 3.8 • n=533 Participants	33.7 years STANDARD_DEVIATION 3.7 • n=1066 Participants
Sex: Female, Male Female	533 Participants n=533 Participants	533 Participants n=533 Participants	1066 Participants n=1066 Participants
Sex: Female, Male Male	0 Participants n=533 Participants	0 Participants n=533 Participants	0 Participants n=1066 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	41 participants n=533 Participants	37 participants n=533 Participants	78 participants n=1066 Participants
Region of Enrollment Denmark	40 participants n=533 Participants	41 participants n=533 Participants	81 participants n=1066 Participants
Region of Enrollment United Kingdom	106 participants n=533 Participants	112 participants n=533 Participants	218 participants n=1066 Participants
Region of Enrollment Australia	346 participants n=533 Participants	343 participants n=533 Participants	689 participants n=1066 Participants

PRIMARY outcome

Timeframe: After 7-9 weeks of gestation

Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

Outcome measures

Outcome measures
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.
Clinical Pregnancy Rate	257 Participants	248 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.
Live Birth Rate	232 Participants	212 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.
Positive hCG Rate Per Randomized Patient	303 Participants	297 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.
Rate of Non-viable Pregnancies	46 Participants	49 Participants

SECONDARY outcome

Timeframe: After 7-9 weeks of gestation

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

Outcome measures

Outcome measures
Measure	Embryo Selection by Standard Morphologic Criteria n=533 Participants 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.	Embryo Selection by iDA n=533 Participants 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. 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.
Ongoing Pregnancy Rate	241 Participants	229 Participants

Adverse Events

Embryo Selection by Standard Morphologic Criteria

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Embryo Selection by iDA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr. Jørgen Berntsen

Vitrolife A/S

Phone: +4551542005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place