US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

This study is currently recruiting participants.

Verified March 2013 by Auxogyn, Inc.

Sponsor:

Information provided by (Responsible Party):

Auxogyn, Inc.

ClinicalTrials.gov Identifier:

NCT01671657

First received: August 21, 2012

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2012

Last Updated Date

March 18, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01671657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Official Title ^ICMJE

US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Brief Summary

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

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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).

Publications *

Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. Epub 2010 Oct 3.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

March 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01671657

Other Study ID Numbers ^ICMJE

2012-AUX-008

Has Data Monitoring Committee

Responsible Party

Auxogyn, Inc.

Study Sponsor ^ICMJE

Auxogyn, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Shehua Shen, MD, ELD

Auxogyn, Inc.

Information Provided By

Auxogyn, Inc.

Verification Date

March 2013

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

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