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NCT Number: NCT01635049

Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 43 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Associates of New Jersey, Morristown, New Jersey, United States

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About this study

The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≤43 years of age.
  • Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
  • Willing to have all 2PN embryos monitored by Eeva
  • Not previously enrolled in this study.
  • No concurrent participation in another clinical study.
  • Willing to comply with study protocol and procedures and able to speak English.
  • Willing to provide written informed consent.

Exclusion criteria

  • BMI ≥ 40
  • Prior IVF cycle with < 4 x 2PN
  • Diminished ovarian reserve as demonstrated by any one of the following:
  • BAFC < 6 at time of cycle start
  • Maximum prior FSH > 15
  • AMH < 0.5

Treatment and study plan

Primary outcomes

  1. Eeva time-lapse parameters and CCS

    Time frame: 5-6 days

    Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.

Secondary outcomes

  1. Correlation of time-lapse parameters collected by the Eeva System and implantation rate.

    Time frame: 6 weeks

  2. Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate

    Time frame: 6 weeks

  3. Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate

    Time frame: 7 - 8 weeks

  4. Correlation of time-lapse parameters collected by the Eeva System and delivery rate

    Time frame: live birth

  5. Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate

    Time frame: live birth

  6. Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate

    Time frame: live birth

Sponsors and collaborators

Lead sponsor

Progyny, Inc.

Industry

Registry information

Official study title

Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth

Acronym: CCS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 6, 2012
Registry last updated
Jan 14, 2015

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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