US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

• Conditions: Infertility

• Registration Number: NCT01671657
• Lead Sponsor: Progyny, Inc.

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).

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-23
• Study Start: 2013-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fertility Physicians of Northern California; 🇺🇸 San Jose, California, United States