Infertility
Conditions
Keywords
In vitro fertilization, Assisted reproduction, Noninvasive imaging of embryos, Time lapse imaging of embryos, Traditional morphological grading of embryos, Prediction of blastocysts
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.
Interventions
DEVICEEeva System Study
The Eeva System will image embryos through cleavage and/or blastocyst stage.
Sponsors
Progyny, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. | 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
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Outcome | Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. | Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative. |
Countries
United States
Outcome results
None listed