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
1 other identifier
observational
4,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedStudy Start
First participant enrolled
June 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2027
August 7, 2025
August 1, 2025
2 years
June 4, 2025
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC) will be quantified using logistic regression to assess EQ Score's prediction of utilization.
7 days
Interventions
AI evaluation of embryos inside a time-lapse incubator.
Eligibility Criteria
women undergoing In vitro fertilization (IVF) treatment
You may qualify if:
- 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.
You may not qualify if:
- Women with no available own or donor eggs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fairtilitylead
Study Sites (1)
New England Fertility Institute
Stamford, Connecticut, 06905, United States
Study Officials
- STUDY CHAIR
Klaus Wiemer, PhD
Fairtility
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2025
First Posted
June 12, 2025
Study Start
June 20, 2025
Primary Completion (Estimated)
June 20, 2027
Study Completion (Estimated)
June 20, 2027
Last Updated
August 7, 2025
Record last verified: 2025-08