Gene Expression in Cumulus Cells to Predict Pregnancy

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732900
• Other study ID #: GEMA-201201
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: July 11, 2014
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Gema Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Morphology
Embryos selected for transfer will be based upon morphology alone.
• GemART assay
Embryos selected for transfer will be based upon morphology and GemART assay.

Locations

Country	Name	City	State
United States	IVF Indiana	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Reproductive Medicine Institute	Oak Brook	Illinois
United States	Reproductive Medicine Associates of Michigan	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Gema Diagnostics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No