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Gene Expression in Cumulus Cells to Predict Pregnancy

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ClinicalTrials.gov Identifier: NCT01732900
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gema Diagnostics

Study Description
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Brief Summary:
The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.

Condition or disease Intervention/treatment Phase
Infertility Other: Morphology Other: GemART assay Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Morphology
Embryos selected for transfer will be based on morphology alone.
 Other: Morphology
Embryos selected for transfer will be based upon morphology alone.
Experimental: GemART assay
Embryos selected for transfer will be based upon morphology and GemART assay.
 Other: GemART assay
Embryos selected for transfer will be based upon morphology and GemART assay.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Recorded at post-transfer week 4-9 ]
    Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 21-39 years
  • IVF cycle 1 or 2
  • BMI <35
  • Fertilization method: ICSI and/or IVF
  • Day 3 or day 5 embryo transfer
  • Treatment cycle intended for single or double embryo transfer
  • Use own oocytes, not oocyte donor
  • ≥ 3 embryos at final assessment
  • Donor sperm acceptable
  • Willing to comply with protocol and study procedures

Exclusion Criteria:

  • Polycystic Ovarian Syndrome
  • Presence of fibroid(s): >4 cm intramural or submucosal fibroids
  • History of chemotherapy or radiation to the abdomen or pelvis
  • Use of donor oocytes
  • Use of reinseminated oocytes
  • Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
  • Concurrent participation in another clinical study
  • (Male): Surgically removed sperm
  • (Male): <5 million sperm count
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01732900


Locations
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United States, Illinois
Reproductive Medicine Institute
Oak Brook, Illinois, United States, 60523
United States, Indiana
IVF Indiana
Indianapolis, Indiana, United States, 46280
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Reproductive Medicine Associates of Michigan
Troy, Michigan, United States, 48084
Sponsors and Collaborators
Gema Diagnostics
Investigators
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Principal Investigator: John Jarrett, MD IVF Indiana
More Information
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Publications:

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Responsible Party: Gema Diagnostics
ClinicalTrials.gov Identifier: NCT01732900    
Other Study ID Numbers: GEMA-201201
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Gema Diagnostics:
In vitro fertilization
Assisted reproduction
pregnancy outcome
cumulus cells
Additional relevant MeSH terms:
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Infertility