Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: GM-CSF medium Drug: CONTROL |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure |
- Pregnancy rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]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
- Implantation rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]number of embryos implanted
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GM-CSF medium
patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF
|
Drug: GM-CSF medium
incubation of IVF embryos with a specific medium containing GM-CSF
Other Name: Embryogen
|
|
Placebo Comparator: 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.
|
Drug: CONTROL
group of controls treated with a standard IVF medium
Other Name: NORMAL MEDIUM
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations| Contact: Marco Sbracia, MD | +393479037433 | marcandrea@hotmail.com |
| Contact: Fabio Scarpellini, MD | +393278779064 | quelidebercia@hotmail.com |
| Italy | |
| Villa Salaria Fisiopatologia Riproduzione | Recruiting |
| Rome, Italy, 00198 | |
| Contact: Marco Sbracia, MD +393479037433 marcandrea@hotmail.com | |
| Contact: Fabio Scarpellini, MD +393278779064 marcandrea@hotmail.com | |
| Study Chair: | Marco Sbracia, MD | Centre for Endocrinology and Reproductive Medicine, Italy |
More Information
No publications provided
| Responsible Party: | Centre for Endocrinology and Reproductive Medicine, Italy |
| ClinicalTrials.gov Identifier: | NCT01718210 History of Changes |
| Other Study ID Numbers: | HC0005 |
| Study First Received: | March 2, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
|
GM-CSF recurrent implantation failure pregnancy rate IVF |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013