Overview

This trial is active, not recruiting.

Condition infertility
Sponsor Progyny, Inc.
Start date January 2013
End date June 2016
Trial size 100 participants
Trial identifier NCT01671657, 2012-AUX-008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Arm
Day 3 embryo transfers that used Eeva with morphology grading (Test Group).
Day 3 embryo transfers using morphology grading only (from concurrent Control Group).

Primary Outcomes

Measure
Rate of implantation
time frame: 5-6 gestational age

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants of any age.

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.

Additional Information

Official title US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Progyny, Inc..