Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI evaluation of oocytes..
- Who it may be relevant to
- Registry conditions: Fertility Disorders. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CHLOE Oocyte Data Collection Protocol
Overview
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.
Interventions
- Device AI evaluation of oocytes.
AI evaluation of oocytes inside a time-lapse incubator.
Primary outcome measures
- Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation. [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The World Egg and Sperm Bank — Scottsdale
Identifiers
NCT: NCT06928337 · FRT-24-14