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

October 19, 2015 updated by: Progyny, Inc.
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

100

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

  • United States
    • California
      • San Jose, California, United States, 95124
        • Fertility Physicians of Northern California

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 ≤ 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.

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 with morphology grading (Test Group).
Matched case control group
Day 3 embryo transfers using morphology grading only (from concurrent Control Group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5-6 gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
Time Frame: 5-6 weeks gestational age
5-6 weeks gestational age
Ongoing pregnancy rate
Time Frame: Gestational age week 8-12
Gestational age week 8-12
Multiple pregnancy rate
Time Frame: Gestational age weeks 5-6 and 8-12
Gestational age weeks 5-6 and 8-12
Spontaneous miscarriage rate
Time Frame: Gestational age week 8-12
Gestational age week 8-12

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

January 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 21, 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-008

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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