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Completed

NCT Number: NCT01369446

Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

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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, United States

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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.
  • At least 18 years of age.
  • Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
  • Basal FSH < 10 IU.
  • At least 8 normally fertilized eggs (2PN.)
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures and able to speak English.

Exclusion criteria

  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Gestational carriers.
  • Use of reinseminated eggs.
  • Concurrent participation in another clinical study.
  • Previous enrollment in this clinical study.
  • History of cancer.

Treatment and study plan

Eeva System Study

Device

The Eeva System will image embryos through cleavage and/or blastocyst stage.

Primary outcomes

  1. Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.

    Time frame: Embryos cultured through blastocyst stage (Day 5).

    Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.

Secondary outcomes

  1. Pregnancy Outcome

    Time frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.

    Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative.

Sponsors and collaborators

Lead sponsor

Progyny, Inc.

Industry

Registry information

Acronym: Eeva

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2011
Registry last updated
Jul 24, 2012

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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