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

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

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-20

Study Completion Date

2027-06-20

Brief Summary

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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

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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.

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 embryos

AI evaluation of embryos inside a time-lapse incubator.

Intervention Type DEVICE

Eligibility Criteria

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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.