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Use of G-CSF Treatment in Recurrent Implantation Failure

This study is currently recruiting participants.
Verified December 2012 by Centre for Endocrinology and Reproductive Medicine, Italy
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:
NCT01715974
First received: March 2, 2012
Last updated: January 28, 2013
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with G-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.


Condition Intervention Phase
Women With Recurrent Implantation Failure (Three Previous IVF Attempts Failed and at Least 8 Good Embryos Replaced
 Drug: G-CSF group
Drug: CONTROL
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Administration of G-CSF in Women With Recurrent Implantation Failure in IVF Cycles

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • pregnancy outcome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The number of patients pregnant after treatment with G-CSF (60 microgram/day)compared with the number of patients pregnant in the control group


Secondary Outcome Measures:
  • implantation rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    number of embryos implanted


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CONTROL
patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
 Drug: CONTROL
saline infusion every day from the day of embryo transfer through the day of beta HCG test
Other Name: SALINE INFUSION
Experimental: G-CSF group
patients with recurrent implantation failure treated with G-CSF (60 micrograms/day) from the day of embryo transfer through the day of beta hCG test
 Drug: G-CSF group
60 micrograms/day of G-CSF from the day of embryo transfer through the day of beta HCG test
Other Name: G-CSF

Detailed Description:

We previously showed that G-CSF may be useful in the treatment of recurrent abortion. The G-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.

The study will be conducted in 100 women with recurrent implantation failure The inclusion criteria will be, at least three previous failed IVF attempts where at least 8 good embryos were transferred, women less than 40 years old, absence of systemic diseases. These women will undergo IVF cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous G-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women 40 years old or less with three or more previous IVF cycles failed,
  • with a total of at least 8 good embryos replaced in uterus

Exclusion Criteria:

  • chromosomal defects in the patients,
  • metabolic diseases (diabetes etc.)
  • genetic diseases (thalassemia, cystic fibrosis, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715974

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

Locations
Italy
Cerm-Hungaria Recruiting
Rome, Italy, 198
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

Publications:

Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT01715974     History of Changes
Other Study ID Numbers: HC0003
Study First Received: March 2, 2012
Last Updated: January 28, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Centre for Endocrinology and Reproductive Medicine, Italy:
G-CSF, IVF failure,pregnancy

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013