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US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Auxogyn, Inc.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01671657
First received: August 21, 2012
Last updated: June 11, 2014
Last verified: June 2014

August 21, 2012
June 11, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
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).
Rate of clinical pregnancy [ Time Frame: 5-8 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.
Complete list of historical versions of study NCT01671657 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ Time Frame: Gestational age week 10-12 ] [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Time Frame: Gestational age 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 ]
Not Provided
Not Provided
 
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

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

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).

Observational
Observational Model: Case Control
Not Provided
Not Provided
Non-Probability Sample

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

Infertility
Not Provided
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact: Monica Ransom 650-627-7604 mransom@auxogyn.com
United States
 
NCT01671657
2012-AUX-008
No
Auxogyn, Inc.
Auxogyn, Inc.
Not Provided
Study Director: Shehua Shen, MD, ELD Auxogyn, Inc.
Auxogyn, Inc.
June 2014

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