Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Progyny, Inc.160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Infertility

Interventions

Eeva System StudyDEVICE

The Eeva System will image embryos through cleavage and/or blastocyst stage.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

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

Outcomes

Primary Outcomes

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.

Time frame: Embryos cultured through blastocyst stage (Day 5).

Secondary Outcomes

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.

Time frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.

Data from ClinicalTrials.gov

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