Eeva™ Pregnancy Pilot Study (PPS)

Progyny, Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Infertility

Interventions

Eeva™ resultsDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Clinical Pregnancy

Time frame: 7-8 weeks gestation

Secondary Outcomes

Ongoing pregnancy rate

Time frame: 8-12 week gestation

Central Contacts

Monica Ransom

CONTACT

650-627-7604 mransom@auxogyn.com

Data from ClinicalTrials.gov

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