Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study (EPIC)

Progyny

Status: Completed

Conditions: Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT01671644

2012-AUX-005

TST-1872-p (Other Identifier)

Details and patient eligibility

About

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

Full description

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Enrollment: 104 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 ≤ 3.
• Egg age ≤ 40 years.
• Planned Day 3 embryo transfer.
• At least 5 normally fertilized eggs (2PN).
• All 2PN embryos must be imaged by Eeva.
• Normal uterine cavity as evaluated by standard methods.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Willing to comply with study protocol and procedures.
• Willing to provide written informed consent.

Exclusion criteria

• Planned preimplantation genetic diagnosis.
• Planned "freeze all" cycle (oocytes or embryos).
• Concurrent participation in another clinical study.

Trial design

104 participants in 2 patient groups

Eeva Test Group

Description:

Day 3 embryo transfers that used Eeva predictions with morphology grading.

Matched case control group

Description:

Day 3 embryo transfers using morphology grading only (from a matched concurrent control group).