NCT02651285

Use of G-CSF Supplemented IVF Medium in Patients Undergoing IVF

G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 20 Years – 38 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 G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing 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 also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-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 undergoing IVF. 180 infertile women undergoing IVF no more than 37 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 G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered

Conditions

• Infertility
• Embryo Development
• IVF

Interventions

Type	Name	Description
OTHER	G-CSF medium	incubation of IVF embryos with a specific medium containing G-CSF
OTHER	Control	incubation of IVF embryos with a medium without G-CSF

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2016-01-08
• Last updated: 2016-01-08

Locations

1 site across 1 country: Italy