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NCT Number: NCT07017972

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

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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Key information

Conditions

Fertility Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

New England Fertility Institute

Stamford, Connecticut, 06905, United States

Location status: Recruiting

Location contact

Raga Rohaeim, MSc

CONTACT

[email protected]

203-325-3200

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI evaluation of embryos

Device

AI evaluation of embryos inside a time-lapse incubator.

Primary outcomes

  1. Area under the curve (AUC) will be quantified using logistic regression to assess EQ Score's prediction of utilization.

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro Pini, M.D

CONTACT

[email protected]

+541144704026

Sponsors and collaborators

Lead sponsor

Fairtility

Industry

Registry information

Official study title

Multicenter Data Collection and Simulated-Use Assessment for CHLOE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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