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

March 25, 2015 updated by: Progyny, Inc.

MERGE: MulticEnter ReGistry With Eeva

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91436
        • HRC Fertility
      • Palo Alto, California, United States, 94304
        • Stanford Fertility and Reproductive Medicine Center
      • Redondo Beach, California, United States, 90277
        • Reproductive Partners
      • San Francisco, California, United States, 95124
        • Pacific Fertility Center
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Center for Advanced Reproductive Services (UCHC)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
      • Chicago, Illinois, United States, 60610
        • Fertility Centers of Illinois - River North
      • Highland Park, Illinois, United States, 60035
        • Fertility Centers of Illinois, Highland Park IVF Center
    • New York
      • Melville, New York, United States, 11747
        • Long Island IVF
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • University Hospital Fertility Center
      • Cincinnati, Ohio, United States, 45209
        • Institute for Reproductive Health
    • Texas
      • San Antonio, Texas, United States, 78229
        • Fertility Center of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.

Exclusion Criteria:

  • history of cancer.
  • gestational carrier.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
In-vitro fertilization using Eeva
Patients undergoing in-vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate
Time Frame: 5-6 gestational weeks
Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up
5-6 gestational weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Pregnancy Rate
Time Frame: 5-6 gestational weeks
Determined by follow-up pregnancy ultrasound outcome
5-6 gestational weeks
Spontaneous Miscarriage Rate
Time Frame: 5-6 gestational weeks
Determined by follow-up pregnancy ultrasound outcome
5-6 gestational weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progyny, Inc.

Investigators

  • Study Director: Shehua Shen, MD, Progyny, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-AUX-009
  • TST 2193-p (Other Identifier: Auxogyn)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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