NCT01732900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

November 14, 2012

Last Update Submit

July 11, 2014

Conditions

Infertility

Keywords

In vitro fertilizationAssisted reproductionpregnancy outcomecumulus cells

Outcome Measures

Primary Outcomes (1)

  • 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.

    Recorded at post-transfer week 4-9

Study Arms (2)

Morphology

ACTIVE COMPARATOR

Embryos selected for transfer will be based on morphology alone.

Other: Morphology

GemART assay

EXPERIMENTAL

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

Other: GemART assay

Interventions

MorphologyOTHER

Embryos selected for transfer will be based upon morphology alone.

Morphology
GemART assayOTHER

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

GemART assay

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Reproductive Medicine Institute

Oak Brook, Illinois, 60523, United States

Location

IVF Indiana

Indianapolis, Indiana, 46280, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Reproductive Medicine Associates of Michigan

Troy, Michigan, 48084, United States

Location

Related Publications (1)

  • 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.

    PMID: 23200692BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • John Jarrett, MD

    IVF Indiana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 26, 2012

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

US(4)