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

Sponsor

Progyny, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01617993

Collaborator

(none)

Enrollment

Locations

Duration (Months)

10.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility

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 Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Eeva Continued Access Study.

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Women undergoing IVF treatment Women undergoing IVF treatment

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Fertility Center	San Francisco	California	United States	94133
2	Fertility Physicians of Northern California	San Jose	California	United States	95124
3	Reproductive Science Center	San Ramon	California	United States	94583