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CompletedNCT01732900Updated Jul 14, 2014

Gene Expression in Cumulus Cells to Predict Pregnancy

An interventional study of Morphology and GemART assay in Infertility, sponsored by Gema Diagnostics. Completed at 4 sites in United States. Open to female participants aged 21 Years to 39 Years. Per ClinicalTrials.gov, last updated 2014-07-14.

Sponsored by Gema Diagnostics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
21 Years to 39 Years
Sex
Female
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Study 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.

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Conditions studied

  • Infertility

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Keywords

  • In vitro fertilization
  • Assisted reproduction
  • pregnancy outcome
  • cumulus cells
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 133 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Gema Diagnostics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
133 participants (actual)

Study arms

  • Active comparator
    Morphology

    Embryos selected for transfer will be based on morphology alone.

    Other: Morphology

  • Experimental
    GemART assay

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

    Other: GemART assay

Interventions

  • OtherMorphology

    Embryos selected for transfer will be based upon morphology alone.

  • OtherGemART assay

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

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What researchers measure

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.

    Time frame: Recorded at post-transfer week 4-9

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Study locations

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

Publications

  • 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. PubMed 23200692 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01732900
Lead sponsor
Gema Diagnostics
Responsible party
Sponsor
First posted
Nov 26, 2012
Start date
Feb 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Jul 14, 2014

Study contacts

John Jarrett, MD
principal investigator · IVF Indiana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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