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Eeva™ Pregnancy Pilot Study (PPS) (PPS)

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ClinicalTrials.gov Identifier: NCT02218255
Recruitment Status : Unknown
Verified October 2015 by Progyny, Inc..
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Progyny, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Device: Eeva™ results Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Eeva™ Pregnancy Pilot Study (PPS)
Study Start Date : August 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Pregnancy [ Time Frame: 7-8 weeks gestation ]

Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 8-12 week gestation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218255


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

Locations
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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
Progyny, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Progyny, Inc.
ClinicalTrials.gov Identifier: NCT02218255    
Other Study ID Numbers: 2013-AUX-010
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by Progyny, Inc.:
In Vitro Fertilization
Additional relevant MeSH terms:
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Infertility