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

F

Fairtility

Status

Enrolling

Conditions

Fertility Disorders

Treatments

Device: AI evaluation of oocytes.

Study type

Observational

Funder types

Industry

Identifiers

NCT06928337
FRT-24-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Pedro Pini, M.D

Data sourced from clinicaltrials.gov

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