Data Collection and Professional Simulated Use Study to Develop an Embryo Quality Artificial Intelligence (AI) Model
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 embryos.
- 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
Multicenter Data Collection and Simulated-Use Assessment for CHLOE
Overview
This protocol supports the reliable development and improvement of Artificial Intelligence (AI)-based applications by enabling training, verification, and validation using high-quality real clinical data. It also aims to enhance machine learning in developmental-use AI software. In addition, the professional user simulated use will ensure correct and easy use of the AI applications.
Detailed description
This data collection protocol aims to allow the reliable and robust development (training, verification, and validations) of Artificial Intelligence (AI) technology-based applications as well as improving the machine learning stage of released devices/applications - an AI - based software, for developmental use only, through inspection of large body of high quality real clinical data. Another important element in the design of the application is the user interface. It is thus important to run simulated use assessments to ensure correct and easy use of the AI application by professional users.
Interventions
- Device AI evaluation of embryos
AI evaluation of embryos inside a time-lapse incubator.
Primary outcome measures
- Area under the curve (AUC) will be quantified using logistic regression to assess EQ Score's prediction of utilization. [Time frame: 7 days]
Eligibility criteria
Inclusion criteria
- Images and data of eggs or embryos available from egg retrievals by women undergoing standard egg-freezing or In vitro fertilization (IVF) treatments, using their own eggs or donor eggs.
- Women at least 18 years of age.
- Embryos or eggs cultured in a time-lapse incubator connected to the AI Embryo Viewer.
Exclusion criteria
- Women with no available own or donor 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
- New England Fertility Institute — Stamford
Identifiers
NCT: NCT07017972 · FRT-25-01