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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: GM-CSF medium; Drug: CONTROL

• Registration Number: NCT01718210
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

Brief 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

Study Timeline

• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Study Start: 2012-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• woman age 40 years old or less,
• 3 or more consecutive previous failed IVF cycles with a total of at least 8 good embryos replaced in uterus

Exclusion Criteria

• chromosomal defects in the couple,
• metabolic diseases (diabetes, etc),
• other genetic diseases (thalassemia, cystic fibrosis, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GM-CSF medium	GM-CSF medium	patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF
CONTROL	CONTROL	50 women with recurrent implantation failure (at leat three previous IVF attempts failed with at least 8 good embryos transferred in uterus)that the obtained with IVF are incubated with a standard medium for IVF, and utilized as control group.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	9 months	The number of patients become pregnant after IVF where GM-CSF medium is used, compared with the number of patients become pregnant in the control group

Secondary Outcome Measures

Name	Time	Method
Implantation rate	9 months	number of embryos implanted

Trial Locations

Locations (1)

Villa Salaria Fisiopatologia Riproduzione; 🇮🇹 Rome, Italy