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Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.

CHLOE Oocyte Data Collection Protocol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06928337
Enrollment
40
Registered
2025-04-15
Start date
2025-05-01
Completion date
2026-05-01
Last updated
2026-09-02

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 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.

Detailed description

The CHLOE-OQ Data Collection Protocol is designed to support the reliable and robust development of the CHLOE technology-based application, ensuring their accuracy and effectiveness in assessing oocyte quality. This protocol facilitates the entire AI model development lifecycle, including training, verification, and validation, to enhance the performance and reliability of machine learning algorithms integrated into the CHLOE application. Additionally, the protocol aims to refine the machine learning stage of the already released OQ applications by incorporating new data and improving model performance over time. A key component of this process includes simulated use assessments, which are conducted to evaluate the usability, accuracy, and overall functionality of CHLOE applications in real-world clinical settings by means of a questionnaire for embryologist using CHLOE. These assessments ensure that the technology is not only scientifically sound but also user-friendly, making it easier for embryologists to integrate CHLOE applications into their workflow efficiently. By adhering to this structured data collection protocol, the CHLOE application can continuously evolve, maintaining high standards of performance and usability in the assessment of oocyte quality.

Interventions

DEVICEAI evaluation of oocytes.

AI evaluation of oocytes 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

* Women at least 18 years of age. * Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.

Exclusion criteria

* Women with autologous eggs

Design outcomes

Primary

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

Countries

United States

Contacts

STUDY_CHAIRKlaus Wiemer, 704 9079714

klaus.wiemer@fairtility.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026