Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01816802
First received: March 20, 2013
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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 Intervention
Infertility
Device: In-vitro fertilization using Eeva

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: MERGE: MulticEnter ReGistry With Eeva

Further study details as provided by Auxogyn, Inc.:

Primary Outcome Measures:
  • Clinical Pregnancy Rate [ Time Frame: 5-6 gestational weeks ] [ Designated as safety issue: No ]
    Determined by first pregnancy ultrasound outcome and optional 12-month phone follow-up


Other Outcome Measures:
  • Multiple Pregnancy Rate [ Time Frame: 5-6 gestational weeks ] [ Designated as safety issue: No ]
    Determined by follow-up pregnancy ultrasound outcome

  • Spontaneous Miscarriage Rate [ Time Frame: 5-6 gestational weeks ] [ Designated as safety issue: No ]
    Determined by follow-up pregnancy ultrasound outcome


Estimated Enrollment: 1200
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of cancer.
  • gestational carrier.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816802

Locations
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
Auxogyn, Inc.
Investigators
Study Director: Shehua Shen, MD Auxogyn, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01816802     History of Changes
Other Study ID Numbers: 2012-AUX-009, TST 2193-p
Study First Received: March 20, 2013
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 01, 2015