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Completed

NCT Number: NCT01671644

Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Gent University Hospital, Ghent, East Flanders, Belgium

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About this study

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

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.
  • IVF cycle attempts ≤ 3.
  • Egg age ≤ 40 years.
  • Planned Day 3 embryo transfer.
  • At least 5 normally fertilized eggs (2PN).
  • All 2PN embryos must be imaged by Eeva.
  • Normal uterine cavity as evaluated by standard methods.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures.
  • Willing to provide written informed consent.

Exclusion criteria

  • Planned preimplantation genetic diagnosis.
  • Planned "freeze all" cycle (oocytes or embryos).
  • Concurrent participation in another clinical study.

Treatment and study plan

Primary outcomes

  1. Rate of clinical pregnancy

    Time frame: 5-8 weeks gestational age

    To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).

Secondary outcomes

  1. Implantation rate (# of implanted embryos out of # of total embryos transferred)

    Time frame: 5-8 weeks gestational age.

  2. Ongoing Pregnancy Rate (gestational week 10-12)

    Time frame: Gestational age week 10-12

  3. Multiple pregnancy rate

    Time frame: Gestational weeks 5-8 and 10-12

  4. Spontaneous miscarriage rate

    Time frame: Gestational age week 10-12

Sponsors and collaborators

Lead sponsor

Progyny, Inc.

Industry

Registry information

Acronym: EPIC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2012
Registry last updated
Oct 20, 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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