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CompletedNCT05455281CHLOEUpdated Mar 5, 2025

Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

An observational study in Fertility Disorders, sponsored by Fairtility. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Fairtility · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
55
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Fertility Disorders
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In context

Lead sponsor

Fairtility is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Women undergoing fresh IVF treatment

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
55 participants (actual)
Patient registry
No

Interventions

  • DeviceCHLOE

    CHLOE is designed to automatically analyze events related to embryo development from Time Lapse Incubator (TLI) images and provide prediction on the likelihood of embryos developing to the blastocyst. This information can assist embryologists and IVF professionals in the selection of the most viable embryo for transfer or freezing, when there are multiple embryos deemed suitable.

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What researchers measure

Primary outcomes

  1. The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos

    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: 3 days

Secondary outcomes

  1. The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos

    The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for all embryos will be measured using odds ratio.

    Time frame: 3 days

  2. Blastocyst formation using traditional human morphology only for all embryos

    The prediction of blastocyst outcome using traditional human morphology only, and the actual blastocyst outcome for all embryos will be measured using odds ratio.

    Time frame: 3 days

  3. Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos

    The prediction of blastocyst outcome using the CHLOE algorithm for each individual embryologist will be measured using odds ratio for a subset of good/fair embryos.

    Time frame: 3 days

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Study locations

3 sites
  • IVF Florida
    Margate, Florida 33063, United States
  • Mayo clinic
    Rochester, Minnesota 55905, United States
  • Hadassah University Hospital
    Jerusalem, 12000, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05455281
Lead sponsor
Fairtility
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Jul 27, 2022
Primary completion
Jun 27, 2023
Completion
Jul 27, 2023
Last update
Mar 5, 2025

Study contacts

Yossi Gilgun-Sherki, PhD, MBA
study director · Head of Clinical and Regulatory Affairs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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