US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Progyny, Inc.1 site in 1 country100 target enrollmentJanuary 2013

ConditionsInfertility

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: Progyny, Inc.
Enrollment: 100
Locations: 1
Primary Endpoint: Rate of implantation
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

June 2016

Last Updated

10 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Progyny, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
•IVF cycle attempts ≤
•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.

Outcomes

Primary Outcomes

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 Outcomes

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