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]

Fertility Disorders Clinical Trial

— CHLOE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455281
• Other study ID #: FRT-01-22
• Status: Completed
• Start date: July 27, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: September 2023
• Source: Fairtility
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Device:
• CHLOE
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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem
United States	IVF Florida	Margate	Florida
United States	Mayo clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Fairtility

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Secondary	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.	3 days
Secondary	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.	3 days
Secondary	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.	3 days