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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF | Experimental | The embryos obtained with IVF in patients included iin this arm will be incubated after fertilization with medium supplemented with G-CSF |
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| CONTROL | Placebo Comparator | The embryos obtained by women undergoing IVF included in this arm will be incubated with a standard medium for IVF, and utilized as control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF medium | Other | incubation of IVF embryos with a specific medium containing G-CSF |
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| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated | 12 months |
| implantation rate | The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of blastocyst developped | The number of blastocysts obtained after IVF where G-CSF medium is used divided for the number of fertilized oocytes | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Sbracia, MD | Contact | +393479037433 | marcandrea@hotmail.com | |
| Fabio Scarpellini, MD | Contact | +393278779064 | quelidebercia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Morgia, MS | Centre for Endocrinology and Reproductive Medicine, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerm-Hungaria | Recruiting | Rome | 00153 | Italy |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Control | Other | incubation of IVF embryos with a medium without G-CSF |
|