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NCT Number: NCT06928337

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The World Egg and Sperm Bank

Scottsdale, Arizona, 85260, United States

Location status: Recruiting

Location contact

Ariel Lovato

CONTACT

[email protected]

1-602-678-1906

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women at least 18 years of age.
  • Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.

Exclusion criteria

  • Women with autologous eggs

Treatment and study plan

AI evaluation of oocytes.

Device

AI evaluation of oocytes inside a time-lapse incubator.

Primary outcomes

  1. Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro Pini, M.D

CONTACT

[email protected]

+54 9 1144704026

Sponsors and collaborators

Lead sponsor

Fairtility

Industry

Registry information

Official study title

CHLOE Oocyte Data Collection Protocol

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Aug 7, 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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