Eeva™ Pregnancy Pilot Study (PPS)

Progyny

Status: Unknown

Conditions: Infertility

Treatments: Device: Eeva™ results

Study type: Interventional

Funder types: Industry

Identifiers

NCT02218255

2013-AUX-010

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Day 3 eSET combined with Eeva

Active Comparator group

Description:

Traditional Morphology + Eeva™ results

Treatment:

Device: Eeva™ results

Day 5 eSET combined with Eeva

Active Comparator group

Description:

Traditional Morphology + Eeva™ results

Treatment:

Device: Eeva™ results

Day 5 eSET with Traditonal Morphology

No Intervention group