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

NCT ID: NCT06928337

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-05-01

Brief Summary

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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

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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

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Fertility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AI evaluation of oocytes.

AI evaluation of oocytes inside a time-lapse incubator.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fairtility

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Wiemer, 704 9079714

Role: STUDY_CHAIR

[email protected]

Locations

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The World Egg and Sperm Bank

Scottsdale, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pedro Pini, M.D

Role: CONTACT

+54 9 1144704026

Facility Contacts

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Ariel Lovato

Role: primary

1-602-678-1906

Other Identifiers

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FRT-24-14

Identifier Type: -

Identifier Source: org_study_id

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