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Trial record 3 of 20 for:    eeva

Eeva™ Pregnancy Pilot Study (PPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Auxogyn, Inc.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT02218255
First received: August 14, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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
Infertility
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)

Resource links provided by NLM:


Further study details as provided by Auxogyn, 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 Primary Completion Date: October 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02218255

Contacts
Contact: Monica Ransom 650-627-7604 mransom@auxogyn.com

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

No publications provided

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT02218255     History of Changes
Other Study ID Numbers: 2013-AUX-010
Study First Received: August 14, 2014
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Auxogyn, Inc.:
In Vitro Fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 23, 2014