<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/NCT04411212</url>
  </required_header>
  <id_info>
    <org_study_id>G-CSF and PRP in RIF</org_study_id>
    <nct_id>NCT04411212</nct_id>
  </id_info>
  <brief_title>G-CSF and PRP in Patients With Recurrent Implantation Failure</brief_title>
  <official_title>Granulocyte Colony-stimulating Factor and Platelet-rich Plasma Group in Patients With Recurrent Implantation Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riyadh Fertility and Reproductive Health center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riyadh Fertility and Reproductive Health center</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 aim of this randomized controlled trial is to determine whether granulocyte&#xD;
      colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes&#xD;
      in patients with recurrent implantation failure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 2</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Five weeks after embryo transfer</time_frame>
    <description>Gestational sac detected by ultrasound examination</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Infertility,Female</condition>
  <arm_group>
    <arm_group_label>Granulocyte colony-stimulating factor and platelet-rich plasma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Granulocyte colony-stimulating factor and platelet-rich plasma group</intervention_name>
    <description>Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.</description>
    <arm_group_label>Granulocyte colony-stimulating factor and platelet-rich plasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients with history of three or more unsuccessful IVF-ET cycles with at least 2 good&#xD;
        quality embryos transferred&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  Uterine anomalies&#xD;
&#xD;
          -  Asherman syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Usama M Fouda, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Riyadh Fertility and Reproductive Health center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Usama M Fouda, Prof.</last_name>
    <phone>+0201095401375</phone>
    <email>umfrfouda@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Riyadh Fertility and Reproductive Health center</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Usama M Fouda, Prof.</last_name>
      <phone>+201095401375</phone>
      <email>umfrfouda@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>Platelet-rich plasma</keyword>
  <keyword>Granulocyte colony-stimulating factor</keyword>
  <keyword>Recurrent implantation failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04411212
org study id: G-CSF and PRP in RIF
nct id: NCT04411212
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized controlled trial is to determine whether granulocyte
      colony-stimulating factor and platelet-rich plasma can be used to enhance the IVF-ET outcomes
      in patients with recurrent implantation failure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical pregnancy rate
time frame: Five weeks after embryo transfer
description: Gestational sac detected by ultrasound examination
arm group label: Granulocyte colony-stimulating factor and platelet-rich plasma
arm group type: Active Comparator
arm group label: Control group
arm group type: Other
intervention type: Drug
intervention name: Granulocyte colony-stimulating factor and platelet-rich plasma group
description: Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.
arm group label: Granulocyte colony-stimulating factor and platelet-rich plasma
intervention type: Other
intervention name: Control group
description: Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
minimum age: 1 Year
maximum age: 35 Years
healthy volunteers: No
last name: Usama M Fouda, Prof.
role: Study Chair
affiliation: Riyadh Fertility and Reproductive Health center
last name: Usama M Fouda, Prof.
phone: +0201095401375
email: umfrfouda@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Lenograstim
sharing ipd: No