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

Fairtility

Status: Enrolling

Conditions: Fertility Disorders

Treatments: Device: AI evaluation of embryos

Study type: Observational

Funder types: Industry

Identifiers

NCT07017972

FRT-25-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: 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.