This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.
This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation. Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No). Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.
Study Type
OBSERVATIONAL
Enrollment
59
the system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5
Weill Cornell Medicine
New York, New York, United States
Cleveland Clinic Fertility
Cleveland, Ohio, United States
Dallas Fertility Center
Dallas, Texas, United States
The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1
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.
Time frame: day 5
The Odds Ratio (OR) for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos
Time frame: Day 5
The Odds Ratio (OR) for predicting blastocyst formation using traditional morphology only
Time frame: Day 5
The Odds Ratio (OR) for Good/Fair embryos predicting blastocyst formation for each individual embryologist
Time frame: Day 5
Embryo level diagnostic performance measures (Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio)
Time frame: Day 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.