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

October 19, 2015 updated by: Progyny, Inc.
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • East Flanders
      • Gent, East Flanders, Belgium, 9000 Gent
        • Gent University Hospital
  • Netherlands
    • South Holland
      • Amsterdam, South Holland, Netherlands, 2500 BH
        • VU University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinical pregnancy
Time Frame: 5-8 weeks gestational age
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).
5-8 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate (# of implanted embryos out of # of total embryos transferred)
Time Frame: 5-8 weeks gestational age.
5-8 weeks gestational age.
Ongoing Pregnancy Rate (gestational week 10-12)
Time Frame: Gestational age week 10-12
Gestational age week 10-12
Multiple pregnancy rate
Time Frame: Gestational weeks 5-8 and 10-12
Gestational weeks 5-8 and 10-12
Spontaneous miscarriage rate
Time Frame: Gestational age week 10-12
Gestational age week 10-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progyny, Inc.

Investigators

  • Study Director: Shehua Shen, MD, ELD, Progyny, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-AUX-005
  • TST-1872-p (Other Identifier: Auxogyn)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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