US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01671657

Acronym

US EPIC

Enrollment

100

Registered

2012-08-23

Start date

2013-01-31

Completion date

2016-06-30

Last updated

2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of implantation	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

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

Countries

United States

Outcome results