NCT01718210

Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure

GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may improve the embryo implantation in patients experiencing recurrent implantation failure in IVF cycles.

Detailed description

In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular there are a group of patients, in young reproductive age, experiencing recurrent implantation failure, nevertheless the good embryos produced and transferred. Recently, it has been showed that culture medium supplemented with GM-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients experiencing recurrent implantation failure. 100 women with recurrent implantation failure, at least three failed previous IVF attempts with at least 8 good embryos transferred no more than 40 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the GM-CSF supplemented culture medium (EmbryoGen, Origio, Denmark), or in normal culture in micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage embryos). A maximum of three embryos will be transferred. The pregnancy rate the implantation rate will be the outcomes considered

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	GM-CSF medium	incubation of IVF embryos with a specific medium containing GM-CSF
DRUG	CONTROL	group of controls treated with a standard IVF medium

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-10-31
• Last updated: 2016-04-27

Locations

1 site across 1 country: Italy