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A Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing IVF [Cultivating Human Life Through Optimal Embryos]

Sponsor
Fairtility (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05455281
Collaborator
(none)
50
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CHLOE

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fairtility

Investigators

  • Study Director: Yossi Gilgun-Sherki, PhD, MBA, Head of Clinical and Regulatory Affairs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fairtility
ClinicalTrials.gov Identifier:
NCT05455281
Other Study ID Numbers:
  • FRT-01-22
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jul 13, 2022