US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Progyny

Status: Unknown

Conditions: Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT01671657

2012-AUX-008

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No 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.

Trial design

100 participants in 2 patient groups

Eeva Test Group

Description:

Day 3 embryo transfers that used Eeva with morphology grading (Test Group).

Matched case control group

Description:

Day 3 embryo transfers using morphology grading only (from concurrent Control Group).