NCT06111365

Pivotal Observational CHLOE Study

A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Fairtility · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.

Detailed description

This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation. Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No). Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.

Conditions

• IVF

Interventions

Type	Name	Description
DEVICE	CHLOE	the system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2023-11-01
• Last updated: 2025-03-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study