Trial record 2 of 14 for:
eeva
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting (CAS)
This study is ongoing, but not recruiting participants.
Sponsor:
Auxogyn, Inc.
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01617993
First received: June 8, 2012
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
User questionnaire of Eeva System usability and reports of device malfunctions.
| Condition | Intervention |
|---|---|
|
Infertility |
Device: Eeva is an Assisted Reproductive Microscope with accessories |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Eeva Continued Access Study. |
Resource links provided by NLM:
Further study details as provided by Auxogyn, Inc.:
Primary Outcome Measures:
- User questionnaire of Eeva System usability and reports of device malfunctions. [ Time Frame: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Women undergoing IVF treatment |
Device: Eeva is an Assisted Reproductive Microscope with accessories
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva prediction along with traditional morphological grading to assist in selecting the best embryo(s).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617993
Locations
| United States, California | |
| Pacific Fertility Center | |
| San Francisco, California, United States, 94133 | |
| Fertility Physicians of Northern California | |
| San Jose, California, United States, 95124 | |
| Reproductive Science Center | |
| San Ramon, California, United States, 94583 | |
Sponsors and Collaborators
Auxogyn, Inc.
Investigators
| Study Director: | Shehua Shen, ELD, MD | Auxogyn, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Auxogyn, Inc. |
| ClinicalTrials.gov Identifier: | NCT01617993 History of Changes |
| Other Study ID Numbers: | 2012-AUX-002 |
| Study First Received: | June 8, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Auxogyn, Inc.:
|
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 |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013