Fertility DisordersCHLOENCT05455281
Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation
An observational study of Fertility Disorders, run by Fairtility at 3 sites in 2 countries.
Trial summary
This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- CHLOE
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Jul 2022to 27 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing fresh IVF treatment
Who may be able to join
- Women undergoing fresh IVF treatment using their own eggs
- At least 18 years of age
- Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed)
- Basal day 3 follicle-stimulating hormone levels (FSH) < 10 IU
- At least 8 normally fertilized eggs at pronuclear (2PN) stage
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm
Show all 9Show fewer
- At least 2 cells embryo
- At least part of the embryos were cultured until Day 5 (i.e., 114-116 hours)
- IVF treatment cycles were performed during 2020-2021
Who cannot join
- Use of re-inseminated eggs
- Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
- Gestational carriers
- Concurrent participation in another clinical study
- Previous enrollment in this clinical study (i.e., previous cycles of the same women)
- History of cancer
- Embryos that underwent biopsy at cleavage stage
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
IVF Florida
Margate, Florida, 33063
Mayo clinic
Rochester, Minnesota, 55905
About this study
Official title: A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts.
Read the detailed description
The study is an observational, prospective, single-arm, multi-center, clinical study in order to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts on Day 5.
- Conditions
- Fertility Disorders
- Being tested
- CHLOE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHLOEDevice
CHLOE is designed to automatically analyze events related to embryo development from Time Lapse Incubator (TLI) images and provide prediction on the likelihood of embryos developing to the blastocyst. This information can assist embryologists and IVF professionals in the selection of the most viable embryo for transfer or freezing, when there are multiple embryos deemed suitable.
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for a subset of good/fair embryos will be measured using odds ratio.
Measured: 3 days
Secondary outcomes (3)
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos
The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for all embryos will be measured using odds ratio.
Measured: 3 days
Blastocyst formation using traditional human morphology only for all embryos
The prediction of blastocyst outcome using traditional human morphology only, and the actual blastocyst outcome for all embryos will be measured using odds ratio.
Measured: 3 days
Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos
The prediction of blastocyst outcome using the CHLOE algorithm for each individual embryologist will be measured using odds ratio for a subset of good/fair embryos.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start27 Jul 2022
- Primary completion27 Jun 2023
- Study completion27 Jul 2023
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
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fairtility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yossi Gilgun-Sherki, PhD, MBA, Study director, Head of Clinical and Regulatory Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455281
- Sponsor's protocol ID
- FRT-01-22
- Acronym
- CHLOE
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Observational, Prospective Study to Evaluate the Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
- ClinicalTrials.gov ID
- NCT05455281
- Acronym / sponsor ID
- CHLOE / FRT-01-22
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- FairtilityIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 13 Jul 2022 (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 is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts.
Detailed description
The study is an observational, prospective, single-arm, multi-center, clinical study in order to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying embryos on Day 3 that are most likely to form blastocysts on Day 5.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing fresh IVF treatment
Key inclusion criteria (9 listed)
- Women undergoing fresh IVF treatment using their own eggs
- At least 18 years of age
- Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed)
- Basal day 3 follicle-stimulating hormone levels (FSH) < 10 IU
- At least 8 normally fertilized eggs at pronuclear (2PN) stage
Key exclusion criteria (7 listed)
- Use of re-inseminated eggs
- Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
- Gestational carriers
- Concurrent participation in another clinical study
- Previous enrollment in this clinical study (i.e., previous cycles of the same women)
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 |
|---|---|---|
| CHLOECHLOE is designed to automatically analyze events related to embryo development from Time Lapse Incubator (TLI) images and provide prediction on the likelihood of embryos developing to the blastocyst. This information can assist embryologists and IVF professionals in the selection of the most viable embryo for transfer or freezing, when there are multiple embryos deemed suitable. | Device | – |
Primary outcome
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos
Time frame: 3 days
The prediction of blastocyst outcome using CHLOE algorithm, and the actual blastocyst outcome for a subset of good/fair embryos will be measured using odds ratio.
3 secondary outcomes
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for all embryos
Time frame: 3 days
Blastocyst formation using traditional human morphology only for all embryos
Time frame: 3 days
Blastocyst formation based on the CHLOE algorithm prediction for a subset of good/fair embryos
Time frame: 3 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 5 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Yossi Gilgun-Sherki, PhD, MBA study director
Head of Clinical and Regulatory Affairs
3 sites in 2 countries: 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 3 sites in 2 countries.
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 9 inclusion and 7 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. 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?
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos (time frame: 3 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 5 Mar 2025.