Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation (NCT05455281) | Clinical Trial Compass
CompletedNot Applicable
Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation
United States, Israel55 participantsStarted 2022-07-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The association between the adjunct prediction using CHLOE of blastocyst outcome and the actual blastocyst outcome for a subset of good/fair embryos