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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01816802
Recruitment Status : Unknown
Verified March 2015 by Progyny, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Progyny, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Infertility Device: In-vitro fertilization using Eeva

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 [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: MERGE: MulticEnter ReGistry With Eeva
Study Start Date : February 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

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.

Primary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 5-6 gestational weeks ]
    Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up

Other Outcome Measures:
  1. Multiple Pregnancy Rate [ Time Frame: 5-6 gestational weeks ]
    Determined by follow-up pregnancy ultrasound outcome

  2. Spontaneous Miscarriage Rate [ Time Frame: 5-6 gestational weeks ]
    Determined by follow-up pregnancy ultrasound outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing in vitro fertilization treatment who provide informed consent and use Eeva in their treatment cycle.

Inclusion Criteria:

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

Exclusion Criteria:

  • history of cancer.
  • gestational carrier.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01816802

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

Additional Information:
Responsible Party: Progyny, Inc. Identifier: NCT01816802     History of Changes
Other Study ID Numbers: 2012-AUX-009
TST 2193-p ( Other Identifier: Auxogyn )
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Progyny, Inc.:
In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female