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US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

This study is currently recruiting participants.
Verified March 2013 by Auxogyn, Inc.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01671657
First received: August 21, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Auxogyn, Inc.:

Primary Outcome Measures:
  • Rate of implantation [ Time Frame: 5-6 gestational age ] [ Designated as safety issue: No ]
    To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).


Secondary Outcome Measures:
  • To evaluate clinical pregnancy rates from the Eeva Test group to the Control group [ Time Frame: 5-6 weeks gestational age ] [ Designated as safety issue: No ]
  • Ongoing pregnancy rate [ Time Frame: Gestational age week 8-12 ] [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Time Frame: Gestational age weeks 5-6 and 8-12 ] [ Designated as safety issue: No ]
  • Spontaneous miscarriage rate [ Time Frame: Gestational age week 8-12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Eeva Test Group
Day 3 embryo transfers that used Eeva with morphology grading (Test Group).
Matched case control group
Day 3 embryo transfers using morphology grading only (from concurrent Control Group).

Detailed Description:

The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.

Criteria

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • IVF cycle attempts ≤ 2.
  • Egg age ≤ 40 years.
  • Planned Day 3 embryo transfer.
  • At least 4 normally fertilized eggs (2PN).
  • All 2PN embryos must be imaged by Eeva.
  • Ejaculated sperm or sperm from the epididymis (fresh or frozen).
  • Willing to comply with study protocol and procedures.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Planned "freeze all" cycle (oocytes or embryos).
  • Sperm retrieved from testicular tissue.
  • Abnormal uterine cavity as evaluated by standard methods.
  • Gestational carrier.
  • Endometriosis
  • Hydrosalpinx.
  • History of cancer.
  • Concurrent participation in another clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671657

Locations
United States, California
Fertility Physicians of Northern California Recruiting
San Jose, California, United States, 95124
Contact: G. David Adamson, MD         gdadamson@arcfertility.com    
Contact: Lourella Palao         lourellapalao@fpnc.com    
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Catherine Racowsky, PhD, HCLD         cracowsky@partners.org    
Sponsors and Collaborators
Auxogyn, Inc.
Investigators
Study Director: Shehua Shen, MD, ELD Auxogyn, Inc.
  More Information

Publications:

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01671657     History of Changes
Other Study ID Numbers: 2012-AUX-008
Study First Received: August 21, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Auxogyn, Inc.:
In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software

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

ClinicalTrials.gov processed this record on June 18, 2013