Eeva 12-well Dish Study (NDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01635036
First received: July 2, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.


Condition Intervention
Infertility
Device: In-vitro fertilization using Eeva

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eeva 12-well Dish Study

Resource links provided by NLM:


Further study details as provided by Auxogyn, Inc.:

Primary Outcome Measures:
  • To validate and develop the Eeva Software. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r).


Secondary Outcome Measures:
  • Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Bland Altman plots for the differences between each observer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women undergoing IVF treatment
Women undergoing IVF treatment
Device: In-vitro fertilization using Eeva
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

Detailed Description:

This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.

This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women in the United States who undergo IVF treatment

Criteria

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • Subject is at least 18 years of age.
  • Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
  • Subjects has basal FSH < 11 IU
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Subject has at least 8 normally fertilized eggs (2PN)
  • 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.
  • Any other reason the Investigator believes the subject should not participate in the clinical study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635036

Locations
United States, California
HRC Fertility
Encino, California, United States, 91436
Sponsors and Collaborators
Auxogyn, Inc.
Investigators
Principal Investigator: Robert Boostanfar, MD HRC Fertility
  More Information

No publications provided

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01635036     History of Changes
Other Study ID Numbers: 2012-AUX-001, TST-1736-p
Study First Received: July 2, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Auxogyn, Inc.:
in vitro fertilization
assisted reproduction techniques
noninvasive imaging of embryos
time lapse imaging of embryos
traditional morphological grading of embryos
prediction of blastocyst formation
infertility
male factor female factor
embryo viability

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014