Gene Expression in Cumulus Cells to Predict Pregnancy

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: GemART assay; Other: Morphology

• Registration Number: NCT01732900
• Lead Sponsor: Gema Diagnostics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-26
• Study Start: 2013-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GemART assay	GemART assay	Embryos selected for transfer will be based upon morphology and GemART assay.
Morphology	Morphology	Embryos selected for transfer will be based on morphology alone.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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.

Trial Locations

Locations (4)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Reproductive Medicine Associates of Michigan; 🇺🇸 Troy, Michigan, United States

IVF Indiana; 🇺🇸 Indianapolis, Indiana, United States

Reproductive Medicine Institute; 🇺🇸 Oak Brook, Illinois, United States