Clinical trial NCT01635036: Eeva 12-well Dish Study
Official title: Eeva 12-well Dish Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: in vitro fertilization
assisted reproduction techniques
noninvasive imaging of embryos
time lapse imaging of embryos
traditional morphological grading of embryos
prediction of blastocyst formation
infertility
male factor female factor
embryo viability
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women in the United States who undergo IVF treatment

Brief summary: The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

Detailed description: This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.

This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians

Eligibility criteria: 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.

Primary outcomes:
measure: To validate and develop the Eeva Software.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
Other outcomes:
measure: The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared.
timeFrame: 3 months
measure: The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3)
timeFrame: 3 months
measure: Bland Altman plots for the differences between each observer.
timeFrame: 3 months
Locations:
city: Encino
country: United States
facility: HRC Fertility
state: California
Study officials:
affiliation: HRC Fertility
name: Robert Boostanfar, MD
role: PRINCIPAL_INVESTIGATOR
References: