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

August 6, 2025 updated by: Fairtility

CHLOE Oocyte Data Collection Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • The World Egg and Sperm Bank
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Oocyte donors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fairtility

Investigators

  • Study Chair: Klaus Wiemer, 704 9079714, klaus.wiemer@fairtility.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • FRT-24-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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