<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/NCT03783208</url>
  </required_header>
  <id_info>
    <org_study_id>20182</org_study_id>
    <nct_id>NCT03783208</nct_id>
  </id_info>
  <brief_title>Intrauterine G-CSF Administration in RIF</brief_title>
  <acronym>G-CSF</acronym>
  <official_title>Intrauterine G-CSF Administration in Recurrent Implantation Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gurgan Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gurgan Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial&#xD;
      thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure&#xD;
      (RIF) group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was designed as a prospective randomized controlled trial with the involvement of&#xD;
      200 RIF group patients.The procedure will perform by administering 30 mIU of&#xD;
      Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow&#xD;
      infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of&#xD;
      1 mL will be infused into the endometrial cavity in the same way in the control group. The&#xD;
      standard ICSI procedure will use for all patients, and fresh cycle embryos will be&#xD;
      transferred on the third or fifth day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>1month</time_frame>
    <description>Gestational sac in USG per embryo transfer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endometrial thickness</measure>
    <time_frame>1month</time_frame>
    <description>Measurement of endometrial thickness as millimeter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>G-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-CSF</intervention_name>
    <description>Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.</description>
    <arm_group_label>G-CSF</arm_group_label>
    <other_name>Leucostim</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women under the age of 40 who met the RIF definition&#xD;
&#xD;
          -  Follicle-stimulating hormone (FSH) levels were &lt;15 IU/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with congenital uterine anomalies&#xD;
&#xD;
          -  Patients with Asherman's syndrome&#xD;
&#xD;
          -  Patients with uterine cavity distorted by myoma or endometrial polyps&#xD;
&#xD;
          -  Patients with confirmed endometriosis or endometrioma&#xD;
&#xD;
          -  Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle&#xD;
             cell anemia, malignancies, chronic neutropenia)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only female participants</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ziya Kalem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gurgan Clinic IVF and Women Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gurgan Clinic IVF and Women Health Center</name>
      <address>
        <city>Ankara</city>
        <state>Cankaya</state>
        <zip>06640</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrium</keyword>
  <keyword>G-CSF</keyword>
  <keyword>Recurrent implantation failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT03783208
org study id: 20182
nct id: NCT03783208
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial
      thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure
      (RIF) group
This study was designed as a prospective randomized controlled trial with the involvement of
      200 RIF group patients.The procedure will perform by administering 30 mIU of
      Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow
      infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of
      1 mL will be infused into the endometrial cavity in the same way in the control group. The
      standard ICSI procedure will use for all patients, and fresh cycle embryos will be
      transferred on the third or fifth day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Clinical pregnancy rate
time frame: 1month
description: Gestational sac in USG per embryo transfer
measure: Endometrial thickness
time frame: 1month
description: Measurement of endometrial thickness as millimeter
arm group label: G-CSF
arm group type: Experimental
description: Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter.
arm group label: Control group
arm group type: Placebo Comparator
description: Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group
intervention type: Drug
intervention name: G-CSF
description: Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.
arm group label: G-CSF
other name: Leucostim
intervention type: Other
intervention name: Saline
description: Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
gender description: Only female participants
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ziya Kalem, MD
role: Principal Investigator
affiliation: Gurgan Clinic IVF and Women Health Center
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Infertility