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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:
NCT01718210
First received: March 2, 2012
Last updated: December 2, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: January 2014 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718210

Contacts
Contact: Marco Sbracia, MD +393479037433 marcandrea@hotmail.com
Contact: Fabio Scarpellini, MD +393278779064 quelidebercia@hotmail.com

Locations
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   
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

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 2, 2013
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, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 20, 2014