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

Infertility Clinical Trial

— CAS  

Official title:

Eeva Continued Access Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617993
• Other study ID #: 2012-AUX-002
• Status: Completed
• Phase: N/A
• First received: June 8, 2012
• Last updated: January 9, 2014
• Start date: June 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Progyny, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	Pacific Fertility Center	San Francisco	California
United States	Fertility Physicians of Northern California	San Jose	California
United States	Reproductive Science Center	San Ramon	California

Sponsors (1)

Lead Sponsor	Collaborator
Progyny, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

•   Auxogyn, Inc. website