US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Progyny, Inc.100 enrolled

Overview

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

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

OBSERVATIONAL

Enrollment

100

Conditions

Infertility

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Fertility Physicians of Northern California

San Jose, California, United States

Outcomes

Primary Outcomes

Rate of implantation

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).

Time frame: 5-6 gestational age

Secondary Outcomes

To evaluate clinical pregnancy rates from the Eeva Test group to the Control group

Time frame: 5-6 weeks gestational age

Ongoing pregnancy rate

Time frame: Gestational age week 8-12

Multiple pregnancy rate

Time frame: Gestational age weeks 5-6 and 8-12

Spontaneous miscarriage rate

Time frame: Gestational age week 8-12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.