Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting

Completed

• Conditions: Infertility

• Registration Number: NCT01617993
• Lead Sponsor: Progyny, Inc.

Brief Summary

User questionnaire of Eeva System usability and reports of device malfunctions.

Detailed Description

This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-13
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
• Subject is ≥ 18 and ≤ 40 years of age.
• Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
• Subject has ≥ 5 normally fertilized eggs (2 PN)
• Willing to have all 2PN embryos monitored by Eeva
• Willing to comply with study protocol and procedures and able to speak English.
• Willing to provide written informed consent.

Exclusion Criteria

• Reinseminated eggs.
• History of cancer.
• Gestational carriers.
• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Previously enrolled in this study
• Concurrent participation in another clinical study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
User questionnaire of Eeva System usability and reports of device malfunctions.	Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age.

Trial Locations

Locations (3)

Pacific Fertility Center; 🇺🇸 San Francisco, California, United States

Reproductive Science Center; 🇺🇸 San Ramon, California, United States

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