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Gene Expression in Cumulus Cells to Predict Pregnancy

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphology
GemART assay
Sponsored by
Gema Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization, Assisted reproduction, pregnancy outcome, cumulus cells

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Medicine Institute
  • IVF Indiana
  • University of Iowa
  • Reproductive Medicine Associates of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morphology

GemART assay

Arm Description

Embryos selected for transfer will be based on morphology alone.

Embryos selected for transfer will be based upon morphology and GemART assay.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2012
Last Updated
July 11, 2014
Sponsor
Gema Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT01732900
Brief Title
Gene Expression in Cumulus Cells to Predict Pregnancy
Official Title
The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gema Diagnostics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization, Assisted reproduction, pregnancy outcome, cumulus cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphology
Arm Type
Active Comparator
Arm Description
Embryos selected for transfer will be based on morphology alone.
Arm Title
GemART assay
Arm Type
Experimental
Arm Description
Embryos selected for transfer will be based upon morphology and GemART assay.
Intervention Type
Other
Intervention Name(s)
Morphology
Intervention Description
Embryos selected for transfer will be based upon morphology alone.
Intervention Type
Other
Intervention Name(s)
GemART assay
Intervention Description
Embryos selected for transfer will be based upon morphology and GemART assay.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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.
Time Frame
Recorded at post-transfer week 4-9

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Jarrett, MD
Organizational Affiliation
IVF Indiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Institute
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
IVF Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Reproductive Medicine Associates of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23200692
Citation
Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.
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Gene Expression in Cumulus Cells to Predict Pregnancy

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