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Data Collection and Professional Simulated Use Study to Develop an Embryo Quality Artificial Intelligence (AI) Model

NCT07017972 — Recruiting, 4000 participants, Fairtility

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Multicenter Data Collection and Simulated-Use Assessment for CHLOE

RegistryNCT07017972
StatusRecruiting
Study typeObservational
Enrollment4000 (Estimated)
SponsorFairtility (Industry)
ConditionsFertility Disorders
InterventionsAI evaluation of embryos (Device)
Datesstart 2025-06-20, primary completion 2027-06-20 (estimated), completion 2027-06-20 (estimated), first posted 2025-06-12, last updated 2025-08-07
Locations1 site in United States

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-Summary

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.

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+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.

+Arms and interventions

  • AI evaluation of embryos (Device): AI evaluation of embryos inside a time-lapse incubator.

+Outcome measures

Primary outcomes

  • Area under the curve (AUC) will be quantified using logistic regression to assess EQ Score's prediction of utilization. [7 days]

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. 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.
2. Women at least 18 years of age.
3. 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.

+Locations (1)

FacilityCityCountryStatus
New England Fertility InstituteStamford, ConnecticutUnited StatesRecruiting

+Investigators

My Notes