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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718210
First Posted: October 31, 2012
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy
  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
Intervention Model: Parallel Assignment
Masking: Single (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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718210


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

Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT01718210     History of Changes
Other Study ID Numbers: HC0005
First Submitted: March 2, 2012
First Posted: October 31, 2012
Last Update Posted: April 27, 2016
Last Verified: April 2016

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