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Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study (EPIC)

This study is currently recruiting participants.
Verified March 2013 by Auxogyn, Inc.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01671644
First received: August 21, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

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 clinical pregnancy [ Time Frame: 5-8 weeks gestational age ] [ Designated as safety issue: No ]
    To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).


Secondary Outcome Measures:
  • Implantation rate (# of implanted embryos out of # of total embryos transferred) [ Time Frame: 5-8 weeks gestational age. ] [ Designated as safety issue: No ]
  • Ongoing Pregnancy Rate (gestational week 10-12) [ Time Frame: Gestational age week 10-12 ] [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Time Frame: Gestational weeks 5-8 and 10-12 ] [ Designated as safety issue: No ]
  • Spontaneous miscarriage rate [ Time Frame: Gestational age week 10-12 ] [ Designated as safety issue: No ]

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

Detailed Description:

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates. as compared to a matched case control group that used morphology grading only to select embryos for transfer.

  Eligibility

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 ≤ 3.
  • Egg age ≤ 40 years.
  • Planned Day 3 embryo transfer.
  • At least 5 normally fertilized eggs (2PN).
  • All 2PN embryos must be imaged by Eeva.
  • Normal uterine cavity as evaluated by standard methods.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Planned preimplantation genetic diagnosis.
  • Planned "freeze all" cycle (oocytes or embryos).
  • Concurrent participation in another clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671644

Locations
Belgium
Gent University Hospital Recruiting
Gent, East Flanders, Belgium, 9000 Gent
Contact: Petra De Sutter, MD, PhD         petra.desutter@ugent.be    
Contact: Etienne Van den Abbeel, PhD         etienne.Vandenabbeel@uzgent.be    
Sub-Investigator: Etienne Van den Abbeel, PhD            
Principal Investigator: Petra De Sutter, MD, PhD            
Netherlands
VU University Medical Center Recruiting
Amsterdam, South Holland, Netherlands, 2500 BH
Contact: Carlijn Vergouw     +31 20 444 3229     carlijn.vergouw@vumc.nl    
Principal Investigator: C.B (Nils) Lambalk, MD, PhD            
Sub-Investigator: E. Hanna Kostelijk, MD            
Sub-Investigator: Carlijn Vergouw            
Sponsors and Collaborators
Auxogyn, Inc.
Investigators
Study Director: Shehua Shen, MD, ELD Auxogyn, Inc.
  More Information

Publications:

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01671644     History of Changes
Other Study ID Numbers: 2012-AUX-005
Study First Received: August 21, 2012
Last Updated: March 18, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Ethics Committee

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