Gene Expression in Cumulus Cells to Predict Pregnancy

July 11, 2014 updated by: Gema Diagnostics

The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Reproductive Medicine Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • IVF Indiana
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Michigan
      • Troy, Michigan, United States, 48084
        • Reproductive Medicine Associates of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Recorded at post-transfer week 4-9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gema Diagnostics

Investigators

  • Principal Investigator: John Jarrett, MD, IVF Indiana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (ESTIMATE)

November 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMA-201201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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