CClinicalTrials.gg
Status unknownNCT02301637PROSPECTUpdated Jul 13, 2015

Eeva System Imaging Study

An observational study in Infertility, sponsored by Progyny, Inc.. Status unknown at 7 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Progyny, Inc. · Observational

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Read the detailed description

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Primary Objectives Include:

To collect imaging data on embryos followed to blastocyst stage (Day 5-6)

Secondary Objectives Include:

To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Progyny, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.

Inclusion criteria

  • At least 18 years of age
  • Women undergoing in vitro fertilization treatment using their own eggs
  • Fresh or Frozen Blastocyst (Day 5-6) transfer
  • At least 5 diploid (2PN) embryos at fertilization check
  • Willing to have all 2PN embryos imaged by Eeva
  • Willing to comply with study protocol and procedures
  • Willing to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
  • Use of donor egg / gestational carrier
  • Fertilization using surgically removed sperm
  • History of cancer
  • Assisted Hatching (AH) on Day 3
05

Study design

Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • DeviceEeva™ Test

    The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.

06

What researchers measure

Primary outcomes

  1. Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.

    Time frame: 36 months

07

Study locations

7 sites
  • FCI (River North)
    Chicago, Illinois 60610, United States
  • Midwest Fertility Specialists
    Carmel, Indiana 46032, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Texas Fertility Center
    Austin, Texas 78731, United States
  • Houston Fertility Institute
    Houston, Texas 77063, United States
  • Seattle Reproductive Medicine
    Seatlle, Washington 98109, United States
  • Fertility Associates
    Wellington, 6011, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02301637
Lead sponsor
Progyny, Inc.
Responsible party
Sponsor
First posted
Nov 26, 2014
Start date
Oct 2014
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Jul 13, 2015

Study contacts

Sheua Shen, MD
study chair · Vice President, Scientific and Medical Affairs

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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