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Eeva™ Pregnancy Pilot Study (PPS) (PPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date October 20, 2015
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Clinical Pregnancy [ Time Frame: 7-8 weeks gestation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Ongoing pregnancy rate [ Time Frame: 8-12 week gestation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eeva™ Pregnancy Pilot Study (PPS)
Official Title  ICMJE Eeva™ Pregnancy Pilot Study (PPS)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Device: Eeva™ results
Study Arms  ICMJE
  • Active Comparator: Day 3 eSET combined with Eeva
    Traditional Morphology + Eeva™ results
    Intervention: Device: Eeva™ results
  • Active Comparator: Day 5 eSET combined with Eeva
    Traditional Morphology + Eeva™ results
    Intervention: Device: Eeva™ results
  • No Intervention: Day 5 eSET with Traditonal Morphology
Publications * Kaser DJ, Bormann CL, Missmer SA, Farland LV, Ginsburg ES, Racowsky C. A pilot randomized controlled trial of Day 3 single embryo transfer with adjunctive time-lapse selection versus Day 5 single embryo transfer with or without adjunctive time-lapse selection. Hum Reprod. 2017 Aug 1;32(8):1598-1603. doi: 10.1093/humrep/dex231.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2014)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218255
Other Study ID Numbers  ICMJE 2013-AUX-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Progyny, Inc.
Study Sponsor  ICMJE Progyny, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Progyny, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP