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Gene Expression in Cumulus Cells to Predict Pregnancy

This study is currently recruiting participants.
Verified May 2013 by Gema Diagnostics
Sponsor:
Information provided by (Responsible Party):
Gema Diagnostics
ClinicalTrials.gov Identifier:
NCT01732900
First received: November 14, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Infertility
 Other: Morphology
Other: GemART assay

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Gema Diagnostics:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: Recorded at post-transfer week 4-9 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732900

Contacts
Contact: Amy Iager, MSc iager@gemadx.com

Locations
United States, Illinois
Reproductive Medicine Institute Recruiting
Oak Brook, Illinois, United States, 60523
Contact: Yola Guzy, Dr. Rinehart Asst     630-954-0054 ext 153        
Contact: Carli Chapman, ELD, ABB     630-954-0094 ext 156     cchapman@teamrmi.com    
Principal Investigator: John Rinehart, MD            
United States, Indiana
Jarrett Fertility Recruiting
Noblesville, Indiana, United States, 46060
Contact: John Jarrett, MD     317-575-6565        
Principal Investigator: John Jarrett, MD            
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Amy Sparks, PhD     319-384-8349        
Principal Investigator: Amy Sparks, PhD, HCLD            
Sponsors and Collaborators
Gema Diagnostics
Investigators
Principal Investigator: John Jarrett, MD Jarrett Fertility Group
  More Information

Publications:

Responsible Party: Gema Diagnostics
ClinicalTrials.gov Identifier: NCT01732900     History of Changes
Other Study ID Numbers: GEMA-201201
Study First Received: November 14, 2012
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Gema Diagnostics:
In vitro fertilization
Assisted reproduction
pregnancy outcome
cumulus cells

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

ClinicalTrials.gov processed this record on May 21, 2013