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US Eeva™ Pregnancy Investigational Clinical Study (US EPIC) (US EPIC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Progyny, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671657
First Posted: August 23, 2012
Last Update Posted: October 20, 2015
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.
Information provided by (Responsible Party):
Progyny, Inc.
  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)

Further study details as provided by Progyny, Inc.:

Primary Outcome Measures:
  • Rate of implantation [ Time Frame: 5-6 gestational age ]
    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 ]
  • Ongoing pregnancy rate [ Time Frame: Gestational age week 8-12 ]
  • Multiple pregnancy rate [ Time Frame: Gestational age weeks 5-6 and 8-12 ]
  • Spontaneous miscarriage rate [ Time Frame: Gestational age week 8-12 ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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): NCT01671657


Locations
United States, California
Fertility Physicians of Northern California
San Jose, California, United States, 95124
Sponsors and Collaborators
Progyny, Inc.
Investigators
Study Director: Shehua Shen, MD, ELD Progyny, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Progyny, Inc.
ClinicalTrials.gov Identifier: NCT01671657     History of Changes
Other Study ID Numbers: 2012-AUX-008
First Submitted: August 21, 2012
First Posted: August 23, 2012
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Progyny, 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