A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 3
- Primary Endpoint
- The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
Study Overview
Brief Summary
This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts.
Detailed Description
The study is an observational, prospective, single-arm, multi-center, clinical study in order to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts on Day 5.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women undergoing fresh IVF treatment using their own eggs
- •At least 18 years of age
- •Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed)
- •Basal day 3 follicle-stimulating hormone levels (FSH) < 10 IU
- •At least 8 normally fertilized eggs at pronuclear (2PN) stage
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm
- •At least 2 cells embryo
- •At least part of the embryos were cultured until Day 5 (i.e., 114-116 hours)
- •IVF treatment cycles were performed during 2020-2021
Exclusion Criteria
- •Use of re-inseminated eggs
- •Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
- •Gestational carriers
- •Concurrent participation in another clinical study
- •Previous enrollment in this clinical study (i.e., previous cycles of the same women)
- •History of cancer
- •Embryos that underwent biopsy at cleavage stage
Outcomes
Primary Outcomes
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
Time Frame: 3 days
The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for a subset of good/fair embryos will be measured using odds ratio.
Secondary Outcomes
- The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos(3 days)
- Blastocyst formation using traditional human morphology only for all embryos(3 days)
- Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos(3 days)