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

Multicenter Data Collection and Simulated-Use Assessment for CHLOE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07017972
Enrollment
4000
Registered
2025-06-12
Start date
2025-06-20
Completion date
2027-06-20
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Disorders

Brief 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.

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

DEVICEAI evaluation of embryos

AI evaluation of embryos inside a time-lapse incubator.

Sponsors

Fairtility
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactPedro Pini, M.D
pedrogpini@gmail.com+541144704026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026