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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718210
• Other study ID #: HC0005
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2012
• Last updated: April 25, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Centre for Endocrinology and Reproductive Medicine, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• GM-CSF medium
incubation of IVF embryos with a specific medium containing GM-CSF
• CONTROL
group of controls treated with a standard IVF medium

Locations

Country	Name	City	State
Italy	Villa Salaria Fisiopatologia Riproduzione	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	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	9 months	No
Secondary	Implantation rate	number of embryos implanted	9 months	No