Infertility Clinical Trial
— EevaOfficial title:
Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
Verified date | July 2012 |
Source | Progyny, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | HRC Fertility | Encino | California |
United States | Stanford University | Palo Alto | California |
United States | Pacific Fertility Center | San Francisco | California |
United States | Fertility Physicians of Northern California | San Jose | California |
United States | Reproductive Science Center | San Ramon | California |
Lead Sponsor | Collaborator |
---|---|
Progyny, Inc. |
United States,
Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. | Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation. | Embryos cultured through blastocyst stage (Day 5). | No |
Secondary | Pregnancy Outcome | 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. | Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. | No |
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