IVFNCT06111365
Pivotal Observational CHLOE Study
An observational study of IVF, run by Fairtility at 3 sites in United States.
Trial summary
This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IVF
- What is being tested?
- CHLOE
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jan 2024to 12 Aug 2024
- 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 using their own eggs or donor eggs
Who may be able to join
- Women undergoing fresh IVF treatment using their own eggs or donor eggs.
- Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
- Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
- Basal follicle-stimulating hormone (FSH) level < 10 IU or AMH > 1.2 ng/ml
- At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- At least 2 cells embryo.
- Embryos were cultured in a Embryoscope ES-D (i.e., EmbryoScope model D - 6 spaces for patients, 12 wells each, resolution - 500*500). The EmbryoScope was configured to the default values provided by EmbryoScope manufacturer.
Who cannot join
- 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
- Use of re-inseminated eggs
- Embryos that underwent day 3 biopsy for preimplantation genetic testing (PGT)
Show all 9Show fewer
- Embryos that underwent biopsy at cleavage stage
- Non-2PN embryos
- Embryos with video frames in which the embryo is not clearly visible. Namely, videos with empty well, Bad Focus, Cropped Embryo, Air Bubble (see Annotation protocol, embryos with "Technical Errors" states)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Fertility
Cleveland, Ohio, 44147
Dallas Fertility Center
Dallas, Texas, 75231
Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.
Read the detailed description
This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.
Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No).
Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.
- Conditions
- IVF
- Being tested
- CHLOE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHLOEDevice
the system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5
| Study group | Role | What they receive |
|---|---|---|
| IVF | Women undergoing fresh IVF treatment using their own eggs or donor eggs Receives: Device: CHLOE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1
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: day 5
Secondary outcomes (4)
The Odds Ratio (OR) for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos
Measured: Day 5
The Odds Ratio (OR) for predicting blastocyst formation using traditional morphology only
Measured: Day 5
The Odds Ratio (OR) for Good/Fair embryos predicting blastocyst formation for each individual embryologist
Measured: Day 5
Embryo level diagnostic performance measures (Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio)
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start22 Jan 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fairtility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111365
- Sponsor's protocol ID
- FRT-02-22
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2023
- Last updated
- 19 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Observational, Prospective Assessment Study to Assess the Performance of Fairtility CHLOE BLAST™ Algorithm for the Prediction of Blastocyst Formation in Women Undergoing In-vitro Fertilization
- ClinicalTrials.gov ID
- NCT06111365
- Acronym / sponsor ID
- FRT-02-22
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- FairtilityIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 1 Nov 2023 (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 pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.
Detailed description
This pivotal study is an observational, prospective assessment, multi-center, databank based, clinical study aimed to evaluate the performance of CHLOE™ algorithm in prediction of blastocyst formation.
Day 3 morphological grading will be performed by three clinical embryologists (hereafter "Assessors"), who will use standard embryo grading assessment techniques and will be blinded to the CHLOE™ information and to the actual blastocyte status (Yes/No).
Five independent embryologists (hereafter "Panelists") who will be masked to imaging data, to actual blastocyst status, and to each other evaluations will be provided with the morphological grading information performed earlier by the 3 assessors and with the age of subject or egg donor. All data will be presented to Panelists as full cohorts of embryos for each mother. Then they will provide their prediction on blastocyst status of each embryo twice: once the prediction will be based on morphology only and once on morphology plus CHLOE™ assigned score ("High", "Medium+", "Medium-", or "Low"). The two assessments will be done with a washout period of at least 2 weeks and no information will be provided to link the two assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF | – | Device: CHLOEWomen undergoing fresh IVF treatment using their own eggs or donor eggs |
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 using their own eggs or donor eggs
Key inclusion criteria (8 listed)
- Women undergoing fresh IVF treatment using their own eggs or donor eggs.
- Women at least 18 years of age; in case of a donor egg the donor shall be at least 18.
- Total antral follicle count (AFC) of at least 12 as measured by ultrasound prior to stimulation (in cases where AFC is performed).
- Basal follicle-stimulating hormone (FSH) level < 10 IU or AMH > 1.2 ng/ml
- At least 8 normally fertilized eggs at bipronuclear (2PN) stage in this in-vitro fertilization cycle.
Key exclusion criteria (9 listed)
- 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
- Use of re-inseminated 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 |
|---|---|---|
| CHLOEthe system will provide to the user a "CHLOE™ score", which is a blastocyst development prediction value, a discrete grading for blastocyst associated with the likelihood of the embryo reaching the blastocyst stage at Day 5 | Device | IVF |
Primary outcome
The Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1
Time frame: day 5
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.
4 secondary outcomes
The Odds Ratio (OR) for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos
Time frame: Day 5
The Odds Ratio (OR) for predicting blastocyst formation using traditional morphology only
Time frame: Day 5
The Odds Ratio (OR) for Good/Fair embryos predicting blastocyst formation for each individual embryologist
Time frame: Day 5
Embryo level diagnostic performance measures (Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio)
Time frame: Day 5
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 19 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Fairtility at 3 sites 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 8 inclusion and 9 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 19 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. 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 Odds Ratio (OR) for the adjunct prediction of blastulation is required to be statistically significantly greater than 1 (time frame: day 5). 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 19 Mar 2025.