Fertility DisordersNCT06928337
Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.
An observational study of Fertility Disorders, run by Fairtility at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- AI evaluation of oocytes.
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Oocyte donors
Who may be able to join
- Women at least 18 years of age.
- Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.
Who cannot join
- Women with autologous eggs
Trial locations and contacts
1 site in 1 country.
United States1 site
The World Egg and Sperm Bank
Scottsdale, Arizona, 85260
About this study
Official title: CHLOE Oocyte Data Collection Protocol
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.
Read the 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.
- Conditions
- Fertility Disorders
- Being tested
- AI evaluation of oocytes.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI evaluation of oocytes.Device
AI evaluation of oocytes inside a time-lapse incubator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 May 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fairtility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Wiemer, 704 9079714, Study chair, klaus.wiemer@fairtility.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928337
- Sponsor's protocol ID
- FRT-24-14
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHLOE Oocyte Data Collection Protocol
- ClinicalTrials.gov ID
- NCT06928337
- Acronym / sponsor ID
- FRT-24-14
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- FairtilityIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Oocyte donors
Key inclusion criteria (2 listed)
- Women at least 18 years of age.
- Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.
Key exclusion criteria (1 listed)
- Women with autologous eggs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI evaluation of oocytes.AI evaluation of oocytes inside a time-lapse incubator. | Device | – |
Primary outcome
Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Wiemer, 704 9079714 study chair
klaus.wiemer@fairtility.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders, run by Fairtility at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.