Gene Expression in Cumulus Cells to Predict Pregnancy

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT01732900

Run by

Gema Diagnostics

People needed

133

Starts

2013-02-01

Expected to finish

2014-03-01

Last updated by the study team

2014-07-14

Who can join

Age: 21 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.