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Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

NCT ID: NCT01369446

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Keywords

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In vitro fertilization Assisted reproduction Noninvasive imaging of embryos Time lapse imaging of embryos Traditional morphological grading of embryos Prediction of blastocysts

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women undergoing IVF treatment

Eeva System Study

Intervention Type DEVICE

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

Interventions

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Eeva System Study

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Progyny, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheua Shen, MD, ELD

Role: STUDY_DIRECTOR

Progyny, Inc.

Locations

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HRC Fertility

Encino, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Pacific Fertility Center

San Francisco, California, United States

Site Status

Fertility Physicians of Northern California

San Jose, California, United States

Site Status

Reproductive Science Center

San Ramon, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20890283 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24726214 (View on PubMed)

Other Identifiers

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TST-1057-p

Identifier Type: -

Identifier Source: org_study_id