Gene Expression in Cumulus Cells to Predict Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gema Diagnostics
ClinicalTrials.gov Identifier:
NCT01732900
First received: November 14, 2012
Last updated: July 11, 2014
Last verified: July 2014
  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:


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.


Enrollment: 133
Study Start Date: February 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
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: NCT01732900

Locations
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
Principal Investigator: John Jarrett, MD IVF Indiana
  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: July 11, 2014
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 August 20, 2014