Infertility, IVF
Conditions
Keywords
Embryo, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate
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.
Interventions
DEVICEiDAScore®
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.
Sponsors
Vitrolife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | After 7-9 weeks of gestation | Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, Denmark, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 533 |
| 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. | 533 |
| Total | 1,066 |
Baseline characteristics
| Characteristic | Embryo Selection by iDA | Total | Embryo Selection by Standard Morphologic Criteria |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 3.8 | 33.7 years STANDARD_DEVIATION 3.7 | 33.7 years STANDARD_DEVIATION 3.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Australia | 343 participants | 689 participants | 346 participants |
| Region of Enrollment Denmark | 41 participants | 81 participants | 40 participants |
| Region of Enrollment Sweden | 37 participants | 78 participants | 41 participants |
| Region of Enrollment United Kingdom | 112 participants | 218 participants | 106 participants |
| Sex: Female, Male Female | 533 Participants | 1066 Participants | 533 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 533 | 0 / 533 |
| other Total, other adverse events | 0 / 533 | 0 / 533 |
| serious Total, serious adverse events | 0 / 533 | 0 / 533 |
Outcome results
Primary
Clinical Pregnancy Rate
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Time frame: After 7-9 weeks of gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryo Selection by Standard Morphologic Criteria | Clinical Pregnancy Rate | 257 Participants |
| Embryo Selection by iDA | Clinical Pregnancy Rate | 248 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
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryo Selection by Standard Morphologic Criteria | Live Birth Rate | 232 Participants |
| Embryo Selection by iDA | Live Birth Rate | 212 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryo Selection by Standard Morphologic Criteria | Ongoing Pregnancy Rate | 241 Participants |
| Embryo Selection by iDA | Ongoing Pregnancy Rate | 229 Participants |
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
Time frame: Tested on day 9-13 following embryo transfer
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryo Selection by Standard Morphologic Criteria | Positive hCG Rate Per Randomized Patient | 303 Participants |
| Embryo Selection by iDA | Positive hCG Rate Per Randomized Patient | 297 Participants |
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
Time frame: After 7-9 weeks of gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Embryo Selection by Standard Morphologic Criteria | Rate of Non-viable Pregnancies | 46 Participants |
| Embryo Selection by iDA | Rate of Non-viable Pregnancies | 49 Participants |