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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embryo selection by standard morphologic criteria | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed | After 7-9 weeks of gestation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Illingworth, A/Prof | Virtus Health, Sydney, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVFAustralia Greenwich | Sydney | Greenwich | 2065 | Australia | ||
| IVFAustralia Alexandria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39122964 | Result | Illingworth PJ, Venetis C, Gardner DK, Nelson SM, Berntsen J, Larman MG, Agresta F, Ahitan S, Ahlstrom A, Cattrall F, Cooke S, Demmers K, Gabrielsen A, Hindkjaer J, Kelley RL, Knight C, Lee L, Lahoud R, Mangat M, Park H, Price A, Trew G, Troest B, Vincent A, Wennerstrom S, Zujovic L, Hardarson T. Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial. Nat Med. 2024 Nov;30(11):3114-3120. doi: 10.1038/s41591-024-03166-5. Epub 2024 Aug 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Embryo Selection by iDA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Pregnancy Rate | Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed | Posted | Count of Participants | Participants | After 7-9 weeks of gestation |
|
Adverse events were recorded up to the date of live birth, i.e. 9 months after embryo transfer.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The time-to-pregnancy and cumulative live birth rates were not assessed, as only the first embryo was prioritized for transfer.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr. Jørgen Berntsen | Vitrolife A/S | +4551542005 | jberntsen@vitrolife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Aug 27, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2022 | Nov 10, 2022 | SAP_000.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
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 |
| Alexandria |
| New South Wales |
| 2015 |
| Australia |
| IVFAustralia, Westmead | Sydney | New South Wales | 2145 | Australia |
| Queensland Fertility Group (QFG) | Benowa | Queensland | 4217 | Australia |
| Melbourne IVF | East Melbourne | Victoria | 3002 | Australia |
| Universitetshospitalet | Aalborg | 9000 | Denmark |
| Aagaard Fertilitetsklinik | Aarhus | 8200 | Denmark |
| Regionshospitalet | Horsens | 8700 | Denmark |
| Livio Gothenburg | Gothenburg | 412 55 | Sweden |
| Reproductive medicine, Sahlgrenska University Hospital | Gothenburg | 413 46 | Sweden |
| Thames Valley Fertility (TFP) | Maidenhead | SL6 4BY | United Kingdom |
| Nurture Fertility (TFP) | Nottingham | NG10 5QG | United Kingdom |
| Oxford Fertility (TFP) | Oxford | OX4 2HW | United Kingdom |
| Wessex Fertility (TFP) | Southampton | SO15 5QS | United Kingdom |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 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 β-hCG pregnancies | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | After 7-9 weeks of gestation |
|
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| 0 |
| 533 |
| 0 |
| 533 |
| 0 |
| 533 |
| EG001 | 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. | 0 | 533 | 0 | 533 | 0 | 533 |
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