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

This study has been completed.
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy Identifier:
First received: March 2, 2012
Last updated: April 25, 2016
Last verified: April 2016
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
Drug: GM-CSF medium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure

Further study details as provided by Centre for Endocrinology and Reproductive Medicine, Italy:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 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 Outcome Measures:
  • Implantation rate [ Time Frame: 9 months ]
    number of embryos implanted

Enrollment: 100
Study Start Date: December 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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.
group of controls treated with a standard IVF 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

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
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Please refer to this study by its identifier: NCT01718210

Villa Salaria Fisiopatologia Riproduzione
Rome, Italy, 00198
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Study Chair: Marco Sbracia, MD Centre for Endocrinology and Reproductive Medicine, Italy
  More Information

Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy Identifier: NCT01718210     History of Changes
Other Study ID Numbers: HC0005
Study First Received: March 2, 2012
Last Updated: April 25, 2016

Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
recurrent implantation failure
pregnancy rate

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 22, 2017