Clinical trial NCT05455281: Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation
Official title: A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Disorders
Lead sponsor: Fairtility
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 55
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
timeFrame: 3 days
Secondary outcomes:
measure: The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos
timeFrame: 3 days
measure: Blastocyst formation using traditional human morphology only for all embryos
timeFrame: 3 days
measure: Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos
timeFrame: 3 days
Other outcomes:
Locations:
city: Margate
country: United States
facility: IVF Florida
state: Florida
city: Rochester
country: United States
facility: Mayo clinic
state: Minnesota
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Head of Clinical and Regulatory Affairs
name: Yossi Gilgun-Sherki, PhD, MBA
role: STUDY_DIRECTOR
References: