<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/NCT02973555</url>
  </required_header>
  <id_info>
    <org_study_id>PRP-HMO-CTIL</org_study_id>
    <nct_id>NCT02973555</nct_id>
  </id_info>
  <brief_title>Platelet-Rich Protein and the Endometrium</brief_title>
  <official_title>Can Platelet-rich Plasma (PRP) Promote Endometrial Growth and Improve Pregnancy Outcome of Patients With Thin Endometrium Undergoing Assisted Reproductive Technology (ART) Treatments?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome&#xD;
      of patients with thin endometrium undergoing ART treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>endometrial thickness &gt;7mm</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive serum pregnancy test</measure>
    <time_frame>14 days post embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>PRP injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PRP injection</intervention_name>
    <description>autologous intrauterine infusion of PRP</description>
    <arm_group_label>PRP injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response&#xD;
             to estrogen (&lt; 7 mm) after at least two standard preparation protocols, of which one&#xD;
             was canceled due to thin endometrium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronit Kochman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ronit Kochman, MD</last_name>
    <phone>+972 508946414</phone>
    <email>kochman@hadassah.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT02973555
org study id: PRP-HMO-CTIL
nct id: NCT02973555
lead sponsor: 
has dmc: No
Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome
      of patients with thin endometrium undergoing ART treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: endometrial thickness >7mm
time frame: 1 month
measure: Positive serum pregnancy test
time frame: 14 days post embryo transfer
arm group label: PRP injection
arm group type: Experimental
intervention type: Other
intervention name: PRP injection
description: autologous intrauterine infusion of PRP
arm group label: PRP injection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: No
last name: Ronit Kochman, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Ronit Kochman, MD
phone: +972 508946414
email: kochman@hadassah.org.il
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No