NCT06928337

Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.

CHLOE Oocyte Data Collection Protocol

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Fairtility · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This data collection protocol is aimed to allow the reliable and robust development (training, verification, and validations) of CHLOE technology-based applications as well as improve the machine learning stage of released devices/applications. Additionally, a simulated use assessments will be conducted to ensure the correct and easy use of the CHLOE applications.

Detailed description

The CHLOE-OQ Data Collection Protocol is designed to support the reliable and robust development of the CHLOE technology-based application, ensuring their accuracy and effectiveness in assessing oocyte quality. This protocol facilitates the entire AI model development lifecycle, including training, verification, and validation, to enhance the performance and reliability of machine learning algorithms integrated into the CHLOE application. Additionally, the protocol aims to refine the machine learning stage of the already released OQ applications by incorporating new data and improving model performance over time. A key component of this process includes simulated use assessments, which are conducted to evaluate the usability, accuracy, and overall functionality of CHLOE applications in real-world clinical settings by means of a questionnaire for embryologist using CHLOE. These assessments ensure that the technology is not only scientifically sound but also user-friendly, making it easier for embryologists to integrate CHLOE applications into their workflow efficiently. By adhering to this structured data collection protocol, the CHLOE application can continuously evolve, maintaining high standards of performance and usability in the assessment of oocyte quality.

Conditions

• Fertility Disorders

Interventions

Type	Name	Description
DEVICE	AI evaluation of oocytes.	AI evaluation of oocytes inside a time-lapse incubator.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-04-15
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States