NCT01369446
Completed
Not Applicable
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
ConditionsInfertility
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Progyny, Inc.
- Enrollment
- 160
- Locations
- 5
- Primary Endpoint
- Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
- •At least 18 years of age.
- •Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
- •Basal FSH \< 10 IU.
- •At least 8 normally fertilized eggs (2PN.)
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
- •Willing to comply with study protocol and procedures and able to speak English.
Exclusion Criteria
- •Planned preimplantation genetic diagnosis or preimplantation genetic screening.
- •Gestational carriers.
- •Use of reinseminated eggs.
- •Concurrent participation in another clinical study.
- •Previous enrollment in this clinical study.
- •History of cancer.
Outcomes
Primary Outcomes
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
Time Frame: Embryos cultured through blastocyst stage (Day 5).
Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.
Secondary Outcomes
- Pregnancy Outcome(Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.)
Study Sites (5)
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