Infertility
Conditions
Brief summary
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
Detailed description
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System. Primary Objectives Include: To collect imaging data on embryos followed to blastocyst stage (Day 5-6) Secondary Objectives Include: To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
Interventions
DEVICEEeva™ Test
The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
Sponsors
Progyny, Inc.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Women undergoing in vitro fertilization treatment using their own eggs * Fresh or Frozen Blastocyst (Day 5-6) transfer * At least 5 diploid (2PN) embryos at fertilization check * Willing to have all 2PN embryos imaged by Eeva * Willing to comply with study protocol and procedures * Willing to provide written informed consent
Exclusion criteria
* Freeze-all due to ovarian hyperstimulation syndrome (OHSS) * Use of donor egg / gestational carrier * Fertilization using surgically removed sperm * History of cancer * Assisted Hatching (AH) on Day 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit. | 36 months |
Countries
New Zealand, United States
Outcome results
None listed