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Clinical Trials/NCT02218255
NCT02218255
Unknown
Not Applicable

Eeva™ Pregnancy Pilot Study (PPS)

Progyny, Inc.1 site in 1 country240 target enrollmentAugust 2014
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ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Progyny, Inc.
Enrollment
240
Locations
1
Primary Endpoint
Clinical Pregnancy
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
June 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Women undergoing fresh in vitro fertilization treatment using their own eggs
  • •≤ 40 years
  • •≥ 4 diploid embryos (i.e. having 2 PNs)
  • •≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
  • •All 2PN embryos (for all 3 arms) must be imaged by Eeva
  • •Subject willing to comply with study protocol and procedures
  • •Subject willing to provide written informed consent

Exclusion Criteria

  • •Preimplantation genetic diagnosis or preimplantation genetic screening
  • •Planned "freeze all" cycle (eggs or embryos)
  • •Asherman's Syndrome
  • •Donor egg
  • •Gestational carrier
  • •Presence of Hydrosalpinx on ultrasound
  • •Concurrent participation in an interventional clinical study

Outcomes

Primary Outcomes

Clinical Pregnancy

Time Frame: 7-8 weeks gestation

Secondary Outcomes

  • Ongoing pregnancy rate(8-12 week gestation)

Study Sites (1)

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