Status:
COMPLETED
Pivotal Observational CHLOE Study
Lead Sponsor:
Fairtility
Conditions:
IVF
Eligibility:
FEMALE
18+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- 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)
Key Trial Info
Start Date :
January 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT06111365
Start Date
January 22 2024
End Date
August 12 2024
Last Update
March 19 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medicine
New York, New York, United States, 10065
2
Cleveland Clinic Fertility
Cleveland, Ohio, United States, 44147
3
Dallas Fertility Center
Dallas, Texas, United States, 75231