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OpenTrials
Completed

NCT Number: NCT01732900

Gene Expression in Cumulus Cells to Predict Pregnancy

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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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Institute, Oak Brook, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphology

Other

Embryos selected for transfer will be based upon morphology alone.

GemART assay

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gema Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2012
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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