Clinical trial NCT06111365: Pivotal Observational CHLOE Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVF
Lead sponsor: Fairtility
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing fresh IVF treatment using their own eggs or donor eggs

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Women undergoing fresh IVF treatment using their own eggs or donor eggs.
2. Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
3. Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
4. Basal follicle-stimulating hormone (FSH) level \< 10 IU or AMH \> 1.2 ng/ml
5. At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
6. Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
7. At least 2 cells embryo.
8. 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:

1. Gestational carriers
2. Concurrent participation in another clinical study
3. Previous enrollment in this clinical study (i.e., previous cycles of the same women)
4. History of cancer
5. Use of re-inseminated eggs
6. Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
7. Embryos that underwent biopsy at cleavage stage
8. Non-2PN embryos
9. 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)

Primary outcomes:
measure: The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1
timeFrame: day 5
Secondary outcomes:
measure: The Odds Ratio (OR) for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos
timeFrame: Day 5
measure: The Odds Ratio (OR) for predicting blastocyst formation using traditional morphology only
timeFrame: Day 5
measure: The Odds Ratio (OR) for Good/Fair embryos predicting blastocyst formation for each individual embryologist
timeFrame: Day 5
measure: Embryo level diagnostic performance measures (Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio)
timeFrame: Day 5
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Fertility
state: Ohio
city: Dallas
country: United States
facility: Dallas Fertility Center
state: Texas
Study officials:
References: