<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01715974</url>
  </required_header>
  <id_info>
    <org_study_id>HC0003</org_study_id>
    <nct_id>NCT01715974</nct_id>
  </id_info>
  <brief_title>Use of GM-CSF Treatment in Recurrent Implantation Failure</brief_title>
  <official_title>Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Endocrinology and Reproductive Medicine, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Endocrinology and Reproductive Medicine, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether in Assisted Reproductive Technologies the&#xD;
      treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate&#xD;
      and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In&#xD;
      this randomized sudy investigators will test this cytokine as a treatment for recurrent&#xD;
      implantation failure after IVF, at leat three failed previous IVF attempts.&#xD;
&#xD;
      The study will be conducted in 100 women with recurrent implantation failure of egg donation&#xD;
      cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts&#xD;
      where at least 4 good blastocysts were transferred, women less than 50 years old, absence of&#xD;
      systemic diseases. These women will undergo egg donation cycle and they will randomly divided&#xD;
      in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from&#xD;
      the day of transfer to the day of β-hCG test, and if it will be positive the treatment will&#xD;
      be continued for other 40 days; the group of control will be treated with subcutaneous saline&#xD;
      solution infusion in the same way of the study group. Primary outcomes will be considered:&#xD;
      pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo&#xD;
      transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>12 months</time_frame>
    <description>The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>implantation rate</measure>
    <time_frame>12 months</time_frame>
    <description>number of embryos implanted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Women With Recurrent Implantation Failure in IVF</condition>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GM-CSF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GM-CSF group</intervention_name>
    <description>30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test</description>
    <arm_group_label>GM-CSF group</arm_group_label>
    <other_name>GM-CSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CONTROL</intervention_name>
    <description>saline infusion every day from the day of embryo transfer through the day of beta HCG test</description>
    <arm_group_label>CONTROL</arm_group_label>
    <other_name>SALINE INFUSION</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women 50 years old or less with three or more previous egg donation cycles failed,&#xD;
&#xD;
          -  with a total of at least 4 blastocysts replaced in uterus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chromosomal defects in the patients,&#xD;
&#xD;
          -  metabolic diseases (diabetes etc.)&#xD;
&#xD;
          -  genetic diseases (thalassemia, cystic fibrosis, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Sbracia, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre for Endocrinology and Reproductive Medicine, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Sbracia, MD</last_name>
    <phone>+393479037433</phone>
    <email>marcandrea@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fabio Scarpellini, MD</last_name>
    <phone>+393278779064</phone>
    <email>marcandrea@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cerm-Hungaria</name>
      <address>
        <city>Rome</city>
        <zip>198</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Sbracia, MD</last_name>
      <phone>+393479037433</phone>
      <email>marcandrea@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Fabio Scarpellini, MD</last_name>
      <phone>+393278779064</phone>
      <email>marcandrea@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.</citation>
    <PMID>19617208</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>March 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GM-CSF, IVF failure,pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01715974
org study id: HC0003
nct id: NCT01715974
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether in Assisted Reproductive Technologies the
      treatment with GM-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.
The GM-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 of egg donation
      cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts
      where at least 4 good blastocysts were transferred, women less than 50 years old, absence of
      systemic diseases. These women will undergo egg donation cycle and they will randomly divided
      in two groups: one (50 women) will be treated with subcutaneous GM-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 live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo
      transfer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: pregnancy outcome
time frame: 12 months
description: The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group
measure: implantation rate
time frame: 12 months
description: number of embryos implanted
arm group label: CONTROL
arm group type: Placebo Comparator
description: patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test
arm group label: GM-CSF group
arm group type: Experimental
description: patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test
intervention type: Drug
intervention name: GM-CSF group
description: 30 micrograms/day of GM-CSF from the day of embryo transfer through the day of beta HCG test
arm group label: GM-CSF group
other name: GM-CSF
intervention type: Drug
intervention name: CONTROL
description: saline infusion every day from the day of embryo transfer through the day of beta HCG test
arm group label: CONTROL
other name: SALINE INFUSION
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Marco Sbracia, MD
role: Study Chair
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
last name: Marco Sbracia, MD
phone: +393479037433
email: marcandrea@hotmail.com
last name: Fabio Scarpellini, MD
phone: +393278779064
email: marcandrea@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
citation: Scarpellini F, Sbracia M. Use of granulocyte colony-stimulating factor for the treatment of unexplained recurrent miscarriage: a randomised controlled trial. Hum Reprod. 2009 Nov;24(11):2703-8. doi: 10.1093/humrep/dep240. Epub 2009 Jul 17.
PMID: 19617208
responsible party type: Sponsor
mesh term: Recurrence
mesh term: Molgramostim
mesh term: Sargramostim