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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: GM-CSF medium
* Drug: CONTROL


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GM-CSF medium<br>patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF | Drug: GM-CSF medium<br>* incubation of IVF embryos with a specific medium containing GM-CSF<br>* Other names: Embryogen;|
| Placebo Comparator: CONTROL<br>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. | Drug: CONTROL<br>* group of controls treated with a standard IVF medium<br>* Other names: NORMAL MEDIUM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | number of embryos implanted | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, GM-CSF, recurrent implantation failure, pregnancy rate