<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/NCT02996760</url>
  </required_header>
  <id_info>
    <org_study_id>1404-BIO-019-MF</org_study_id>
    <nct_id>NCT02996760</nct_id>
  </id_info>
  <brief_title>Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.</brief_title>
  <official_title>Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Bilbao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVI Bilbao</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>
      Women in assisted reproduction treatment they receive own or donated embryos and presenting&#xD;
      an endometrial development less than 5 mm despite having received treatment with estrogen&#xD;
      therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level&#xD;
      applications to improve endometrial thickness endometrial preparations for embryo transfer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulty in recruiting&#xD;
  </why_stopped>
  <start_date type="Actual">March 14, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the growth of endometrial thickness</measure>
    <time_frame>During ovarian stimulation protocol 8-12 days</time_frame>
    <description>The endometrial thickness will be measured by vaginal ultrasound. Endometrium less than 5 mm will be treated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analyze the impact of using platelet plasma on rates of implantation and pregnancy.</measure>
    <time_frame>During ovarian stimulation protocol 8-12 days</time_frame>
    <description>The biochemical determination of the hormone ßhcg will be performed 12 days after embryo transfer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Endometrial Development</condition>
  <arm_group>
    <arm_group_label>Endometrium with less than 5mm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.&#xD;
Less than 5mm despite 10 days with standard doses of estrogen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endometrium with more than 5mm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.&#xD;
More than 5mm despite 10 days with standard doses of estrogen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Growth Factor, Platelet-Derived</intervention_name>
    <description>0,5 mL, vaginal use , 3 dose number</description>
    <arm_group_label>Endometrium with less than 5mm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women receiving cycle of oocytes outside or embryos (own / others), in the treatment&#xD;
             of substituted cycle type.&#xD;
&#xD;
          -  Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h)&#xD;
             Endometrio&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of pelvic inflammatory disease&#xD;
&#xD;
          -  Risk of infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IVI Bilbao</name>
      <address>
        <city>Leioa</city>
        <state>Vizcaya</state>
        <zip>48940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</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/NCT02996760
org study id: 1404-BIO-019-MF
nct id: NCT02996760
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Women in assisted reproduction treatment they receive own or donated embryos and presenting
      an endometrial development less than 5 mm despite having received treatment with estrogen
      therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level
      applications to improve endometrial thickness endometrial preparations for embryo transfer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the growth of endometrial thickness
time frame: During ovarian stimulation protocol 8-12 days
description: The endometrial thickness will be measured by vaginal ultrasound. Endometrium less than 5 mm will be treated
measure: Analyze the impact of using platelet plasma on rates of implantation and pregnancy.
time frame: During ovarian stimulation protocol 8-12 days
description: The biochemical determination of the hormone ßhcg will be performed 12 days after embryo transfer
arm group label: Endometrium with less than 5mm
arm group type: Experimental
description: Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
Less than 5mm despite 10 days with standard doses of estrogen
arm group label: Endometrium with more than 5mm
arm group type: No Intervention
description: Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
More than 5mm despite 10 days with standard doses of estrogen
intervention type: Drug
intervention name: Growth Factor, Platelet-Derived
description: 0,5 mL, vaginal use , 3 dose number
arm group label: Endometrium with less than 5mm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Mitogens