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Completed

NCT Number: NCT05455281

Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation

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.

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Key information

Conditions

Fertility Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah University Hospital, Jerusalem, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHLOE

Device

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.

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

    Time frame: 3 days

    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.

Secondary outcomes

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

    Time frame: 3 days

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

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

    Time frame: 3 days

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

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

    Time frame: 3 days

    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.

Sponsors and collaborators

Lead sponsor

Fairtility

Industry

Registry information

Official study 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

Acronym: CHLOE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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