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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02651285
Study type	Interventional
Source	Centre for Endocrinology and Reproductive Medicine, Italy
Contact	Marco Sbracia, MD
Phone	+393479037433
Email	marcandrea@hotmail.com
Status	Recruiting
Phase	Phase 4
Start date	January 2016
Completion date	March 2017

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