Eeva™ Pregnancy Pilot Study (PPS)
Not Applicable
- Conditions
- Infertility
- Interventions
- Device: Eeva™ results
- Registration Number
- NCT02218255
- Lead Sponsor
- Progyny, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Day 3 eSET combined with Eeva Eeva™ results Traditional Morphology + Eeva™ results Day 5 eSET combined with Eeva Eeva™ results Traditional Morphology + Eeva™ results
- Primary Outcome Measures
Name Time Method Clinical Pregnancy 7-8 weeks gestation
- Secondary Outcome Measures
Name Time Method Ongoing pregnancy rate 8-12 week gestation
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States