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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Users Study Of The Caverject Delivery System

NCT01747928

Healthy

COMPLETED EARLY_PHASE1

Human Factors Usability Study of Ib2C Conception System

NCT01564940

Cervical Cap Insemination

COMPLETED

Efficacy of the Quell Wearable Device for Chronic Low Back Pain

NCT02944513

Low Back Pain

COMPLETED NA

Investigational On-body Injector Clinical Study

NCT05553418

Healthy Volunteers

COMPLETED NA

Béa Applicator and Béa Cervical Cap Safety and Usability Study

NCT05129553

Safety and Usability

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women undergoing IVF treatment

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No