Registry Study of Traditional Morphology Grading Combined With Eeva in IVF Treatment

NCT ID: NCT01816802

Last Updated: 2015-03-26

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

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to record and evaluate the use of traditional morphology grading combined with Eeva in the treatment of in vitro fertilization.

Detailed Description

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This is a prospective, observational, single-arm, nonrandomized, multicenter study. Data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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In-vitro fertilization using Eeva

Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.

In-vitro fertilization using Eeva

Intervention Type DEVICE

Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

Interventions

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In-vitro fertilization using Eeva

Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

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.

Exclusion Criteria

* history of cancer.
* gestational carrier.
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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Shehua Shen, MD

Role: STUDY_DIRECTOR

Progyny, Inc.

Locations

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HRC Fertility

Encino, California, United States

Site Status

Stanford Fertility and Reproductive Medicine Center

Palo Alto, California, United States

Site Status

Reproductive Partners

Redondo Beach, California, United States

Site Status

Pacific Fertility Center

San Francisco, California, United States

Site Status

Center for Advanced Reproductive Services (UCHC)

Farmington, Connecticut, United States

Site Status

Fertility Centers of Illinois - River North

Chicago, Illinois, United States

Site Status

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Fertility Centers of Illinois, Highland Park IVF Center

Highland Park, Illinois, United States

Site Status

Long Island IVF

Melville, New York, United States

Site Status

University Hospital Fertility Center

Beachwood, Ohio, United States

Site Status

Institute for Reproductive Health

Cincinnati, Ohio, United States

Site Status

Fertility Center of San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.auxogyn.com

Auxogyn, Inc. website

Other Identifiers

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TST 2193-p

Identifier Type: OTHER

Identifier Source: secondary_id

2012-AUX-009

Identifier Type: -

Identifier Source: org_study_id

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