Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.
CHLOE Oocyte Data Collection Protocol
1 other identifier
observational
350
1 country
1
Brief Summary
This data collection protocol is aimed to allow the reliable and robust development (training, verification, and validations) of CHLOE technology-based applications as well as improve the machine learning stage of released devices/applications. Additionally, a simulated use assessments will be conducted to ensure the correct and easy use of the CHLOE 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 May 2025
Shorter than P25 for all trials
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
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 7, 2025
April 1, 2025
1 year
March 27, 2025
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.
7 days
Interventions
AI evaluation of oocytes inside a time-lapse incubator.
Eligibility Criteria
Oocyte donors
You may qualify if:
- Women at least 18 years of age.
- Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.
You may not qualify if:
- Women with autologous eggs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fairtilitylead
Study Sites (1)
The World Egg and Sperm Bank
Scottsdale, Arizona, 85260, United States
Study Officials
- STUDY CHAIR
Klaus Wiemer, 704 9079714
klaus.wiemer@fairtility.com
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 15, 2025
Study Start
May 1, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
August 7, 2025
Record last verified: 2025-04