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Use of G-CSF Treatment in Recurrent Implantation Failure

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ClinicalTrials.gov Identifier: NCT01715974
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary:
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 or disease Intervention/treatment 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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Administration of G-CSF in Women With Recurrent Implantation Failure in IVF Cycles
Study Start Date : December 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. pregnancy outcome [ Time Frame: 12 months ]
    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 :
  1. implantation rate [ Time Frame: 12 months ]
    number of embryos implanted



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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:

  • 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.)

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): NCT01715974


Locations
Italy
Cerm-Hungaria
Rome, Italy, 198
Sponsors and Collaborators
Centre for Endocrinology and Reproductive Medicine, Italy
Investigators
Study Chair: Marco Sbracia, MD Centre for Endocrinology and Reproductive Medicine, Italy

Publications:
Responsible Party: Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier: NCT01715974     History of Changes
Other Study ID Numbers: HC0003
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

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