Pivotal Observational CHLOE Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

Conditions
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IVF

Intervention / Treatment
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* Device: CHLOE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing fresh IVF treatment using their own eggs or donor eggs. Women at least 18 years of age; in case of a donor egg the donor shall be at least 18. Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed). Basal follicle-stimulating hormone (FSH) level < 10 IU. At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle. Inclusion criteria related to the embryos: Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. At least 2 cells embryo. Embryos were cultured in a Embryoscope ES-D (i.e., EmbryoScope model D - 6 spaces for patients, 12 wells each, resolution - 500*500). The EmbryoScope was configured to the default values provided by EmbryoScope manufacturer. Exclusion Criteria: Exclusion criteria related to the biological mother (or egg donor): 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 Exclusion criteria related to the embryos: Use of re-inseminated eggs Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT) Embryos that underwent biopsy at cleavage stage Non-2PN embryos Embryos with video frames in which the embryo is not clearly visible. Namely, videos with empty well, Bad Focus, Cropped Embryo, Air Bubble (see Annotation protocol, embryos with Technical Errors states)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF<br>Women undergoing fresh IVF treatment using their own eggs or donor eggs | Device: CHLOE<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo blastocyst prediction | High Medium+ Medium- Low | day 5 |