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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718210

Enrollment

100

Registered

2012-10-31

Start date

2012-12-31

Completion date

2015-12-31

Last updated

2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

GM-CSF, recurrent implantation failure, pregnancy rate, IVF

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

Interventions

DRUGGM-CSF medium

incubation of IVF embryos with a specific medium containing GM-CSF

DRUGCONTROL

group of controls treated with a standard IVF medium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Implantation rate	9 months	number of embryos implanted

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026