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Trial record 3 of 23 for:    eeva

Eeva™ Pregnancy Pilot Study (PPS) (PPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Progyny, Inc.
Information provided by (Responsible Party):
Progyny, Inc. Identifier:
First received: August 14, 2014
Last updated: October 19, 2015
Last verified: October 2015
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.

Condition Intervention
Device: Eeva™ results

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eeva™ Pregnancy Pilot Study (PPS)

Further study details as provided by Progyny, Inc.:

Primary Outcome Measures:
  • Clinical Pregnancy [ Time Frame: 7-8 weeks gestation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 8-12 week gestation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: August 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Day 3 eSET combined with Eeva
Traditional Morphology + Eeva™ results
Device: Eeva™ results
Active Comparator: Day 5 eSET combined with Eeva
Traditional Morphology + Eeva™ results
Device: Eeva™ results
No Intervention: Day 5 eSET with Traditonal Morphology


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02218255

Contact: Monica Ransom 650-627-7604

United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Catherine Racowsky, Ph.D.    617-732-5570   
Principal Investigator: Catherine Racowsky, Ph.D.         
Sponsors and Collaborators
Progyny, Inc.
  More Information

Responsible Party: Progyny, Inc. Identifier: NCT02218255     History of Changes
Other Study ID Numbers: 2013-AUX-010 
Study First Received: August 14, 2014
Last Updated: October 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Progyny, Inc.:
In Vitro Fertilization

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on September 29, 2016