Infertility
Conditions
Keywords
In Vitro Fertilization
Brief summary
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.
Interventions
DEVICEEeva™ results
Sponsors
Progyny, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing fresh in vitro fertilization treatment using their own eggs * ≤ 40 years * ≥ 4 diploid embryos (i.e. having 2 PNs) * ≤ 3 Prior ART cycles (IVF, ICSI and related procedures) * All 2PN embryos (for all 3 arms) must be imaged by Eeva * Subject willing to comply with study protocol and procedures * Subject willing to provide written informed consent
Exclusion criteria
* Preimplantation genetic diagnosis or preimplantation genetic screening * Planned freeze all cycle (eggs or embryos) * Asherman's Syndrome * Donor egg * Gestational carrier * Presence of Hydrosalpinx on ultrasound * Concurrent participation in an interventional clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Pregnancy | 7-8 weeks gestation |
Secondary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate | 8-12 week gestation |
Countries
United States
Contacts
Primary ContactMonica Ransom
Outcome results
None listed