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

Eeva Continued Access Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01617993

Acronym

CAS

Enrollment

Registered

2012-06-13

Start date

2012-06-30

Completion date

2013-02-28

Last updated

2014-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

in vitro fertilization, assisted reproduction, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, Genital Diseases, Male, Genital Diseases, Female

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Outcome results