NCT01369446

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

June 7, 2011

Last Update Submit

July 20, 2012

Conditions

Infertility

Keywords

In vitro fertilizationAssisted reproductionNoninvasive imaging of embryosTime lapse imaging of embryosTraditional morphological grading of embryosPrediction of blastocysts

Outcome Measures

Primary Outcomes (1)

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

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

    Embryos cultured through blastocyst stage (Day 5).

Secondary Outcomes (1)

  • Pregnancy Outcome

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

Study Arms (1)

Women undergoing IVF treatment

Device: Eeva System Study

Interventions

Eeva System StudyDEVICE

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

Women undergoing IVF treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

HRC Fertility

Encino, California, 91436, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Pacific Fertility Center

San Francisco, California, 94133, United States

Location

Fertility Physicians of Northern California

San Jose, California, 95124, United States

Location

Reproductive Science Center

San Ramon, California, 94583, United States

Location

Related Publications (2)

  • Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.

    PMID: 20890283BACKGROUND

  • Athayde Wirka K, Chen AA, Conaghan J, Ivani K, Gvakharia M, Behr B, Suraj V, Tan L, Shen S. Atypical embryo phenotypes identified by time-lapse microscopy: high prevalence and association with embryo development. Fertil Steril. 2014 Jun;101(6):1637-48.e1-5. doi: 10.1016/j.fertnstert.2014.02.050. Epub 2014 Apr 14.

    PMID: 24726214DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Sheua Shen, MD, ELD

    Progyny, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

US(5)