Eeva 12-well Dish Study

NCT01635036 | Completed

• 2 other identifiers: 2012-AUX-001TST-1736-p
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To validate and develop the Eeva Software.

  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).

  3 months

Secondary Outcomes (1)

• 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.

  3 months

Other Outcomes (3)

• The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared.

  3 months

• The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3)

  3 months

• Bland Altman plots for the differences between each observer.

  3 months

Study Arms (1)

Women undergoing IVF treatment

Women undergoing IVF treatment

Device: In-vitro fertilization using Eeva

Interventions

In-vitro fertilization using Eeva DEVICE

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.

Women undergoing IVF treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women in the United States who undergo IVF treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Progyny, Inc.: lead

Study Sites (1)

HRC Fertility

Encino, California, 91436, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Robert Boostanfar, MD

  HRC Fertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)