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Completed

NCT Number: NCT01635036

Eeva 12-well Dish Study

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

HRC Fertility

Encino, California, 91436, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. To validate and develop the Eeva Software.

    Time frame: 3 months

    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 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.

    Time frame: 3 months

Other outcomes

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

    Time frame: 3 months

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

    Time frame: 3 months

  3. Bland Altman plots for the differences between each observer.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Progyny, Inc.

Industry

Registry information

Acronym: NDS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2012
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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