Eeva„¢ Pregnancy Pilot Study (PPS)

Description

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 Start Date

August 2014

Estimated Completion Date

June 2016

Interventions

  • Device: Eeva™ results
  • Device: Eevaâ„¢ results

Specialties

  • Obstetrics & Gynecology: Radiology/Diagnostics
  • Physician Assistant: Obstetrics/Gynecology

MeSH Terms

  • Eeva™ results
  • Infertility

Study ID

Auxogyn, Inc. -- 2013-AUX-010

Status

Unknown

Trial ID

NCT02218255

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

240

Sponsor

Auxogyn, Inc.

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Catherine Racowsky PhD 617-732-5570 cracowsky@partners.org

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