Overview

This trial is active, not recruiting.

Condition infertility
Treatment eeva™ test
Sponsor Progyny, Inc.
Start date October 2014
End date December 2015
Trial size 500 participants
Trial identifier NCT02301637, 2014-AUX-012

Summary

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
time frame: 36 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - At least 18 years of age - Women undergoing in vitro fertilization treatment using their own eggs - Fresh or Frozen Blastocyst (Day 5-6) transfer - At least 5 diploid (2PN) embryos at fertilization check - Willing to have all 2PN embryos imaged by Eeva - Willing to comply with study protocol and procedures - Willing to provide written informed consent Exclusion Criteria: - Freeze-all due to ovarian hyperstimulation syndrome (OHSS) - Use of donor egg / gestational carrier - Fertilization using surgically removed sperm - History of cancer - Assisted Hatching (AH) on Day 3

Additional Information

Official title Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
Description The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System. Primary Objectives Include: To collect imaging data on embryos followed to blastocyst stage (Day 5-6) Secondary Objectives Include: To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Progyny, Inc..