Infertility Clinical Trial
— NDSOfficial title:
Eeva 12-well Dish Study
Verified date | January 2014 |
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 is compatible with the Eeva 12-well Dish.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 2012 |
Est. primary completion date | August 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. - Subject is at least 18 years of age. - Subject has basal antral follicle count (BAFC) = 12 prior to stimulation cycle. - Subjects has basal FSH < 11 IU - Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. - Subject has at least 8 normally fertilized eggs (2PN) - Willing to have all 2PN embryos monitored by Eeva - Willing to comply with study protocol and procedures and able to speak English. - Willing to provide written informed consent. Exclusion Criteria: - Reinseminated eggs. - History of cancer. - Gestational carriers. - Planned preimplantation genetic diagnosis or preimplantation genetic screening. - Previously enrolled in this study - Concurrent participation in another clinical study. - Any other reason the Investigator believes the subject should not participate in the clinical study. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | HRC Fertility | Encino | California |
Lead Sponsor | Collaborator |
---|---|
Progyny, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared. | 3 months | No | |
Other | The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3) | 3 months | No | |
Other | Bland Altman plots for the differences between each observer. | 3 months | No | |
Primary | To validate and develop the Eeva Software. | The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r). | 3 months | No |
Secondary | Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed. | 3 months | No |
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