<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/NCT03249415</url>
  </required_header>
  <id_info>
    <org_study_id>1701-FIVI-003-IC</org_study_id>
    <nct_id>NCT03249415</nct_id>
  </id_info>
  <brief_title>Use of PRP in Endometrial Reconstruction</brief_title>
  <official_title>Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación IVI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación IVI</source>
  <brief_summary>
    <textblock>
      Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes;&#xD;
      some causes result from issues related to the endometrium. Unfortunately, no cure exists for&#xD;
      medical conditions resulting in the destruction of the endometrium, or for non-functional&#xD;
      uterus. Thus, safe and effective therapies are needed to treat these diseases and to&#xD;
      establish fertility in affected women. These novel techniques refer to the use and&#xD;
      application of regenerative/paracrine factors to regenerate the endometrium in patients with&#xD;
      Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the&#xD;
      injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP)&#xD;
      from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution&#xD;
      and/or effect in the endometrial repair by functional proofs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to know the effect of these regenerative factors obtained from Platelet-Rich&#xD;
      Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's&#xD;
      Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant&#xD;
      solution and after several centrifugations PRP will be obtained. Demonstration of a&#xD;
      functional endometrium will be proved determining pregnancy and implantation rates as well as&#xD;
      the number of live pups/pregnant female in our mice model. Also, the uterus histology will be&#xD;
      analysed in treated and untreated mice&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 18, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Endometrial thickness after reconstruction in murine model</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Using histological and functional technologies demonstration of regeneration ability of PRP</description>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Asherman Syndrome</condition>
  <condition>Endometrial Atrophy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Platelet-Rich Plasma from Whole Blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.&#xD;
&#xD;
          -  No pregnancy after hormonal treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant with endometrial pathologies.</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Cervello, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación IVI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irene Cervello, PhD</last_name>
    <phone>0034963903305</phone>
    <email>Irene.Cervello@ivi.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>IVI Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irene Cervelló</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Cervello I, Gil-Sanchis C, Santamaria X, Cabanillas S, Diaz A, Faus A, Pellicer A, Simon C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.</citation>
    <PMID>26384164</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Platelet-Rich Plasma</keyword>
  <keyword>Cell therapy</keyword>
  <keyword>Regenerative factors</keyword>
  <keyword>Autologous treatment</keyword>
  <keyword>Paracrine factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gynatresia</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/NCT03249415
org study id: 1701-FIVI-003-IC
nct id: NCT03249415
lead sponsor: 
Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes;
      some causes result from issues related to the endometrium. Unfortunately, no cure exists for
      medical conditions resulting in the destruction of the endometrium, or for non-functional
      uterus. Thus, safe and effective therapies are needed to treat these diseases and to
      establish fertility in affected women. These novel techniques refer to the use and
      application of regenerative/paracrine factors to regenerate the endometrium in patients with
      Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the
      injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP)
      from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution
      and/or effect in the endometrial repair by functional proofs.
The objective is to know the effect of these regenerative factors obtained from Platelet-Rich
      Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's
      Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant
      solution and after several centrifugations PRP will be obtained. Demonstration of a
      functional endometrium will be proved determining pregnancy and implantation rates as well as
      the number of live pups/pregnant female in our mice model. Also, the uterus histology will be
      analysed in treated and untreated mice
observational model: Case-Control
time perspective: Prospective
measure: Endometrial thickness after reconstruction in murine model
time frame: through study completion, an average of 1 year
description: Using histological and functional technologies demonstration of regeneration ability of PRP
Platelet-Rich Plasma from Whole Blood.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Participant with endometrial pathologies.
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: No
last name: Irene Cervello, PhD
role: Principal Investigator
affiliation: Fundación IVI
last name: Irene Cervello, PhD
phone: 0034963903305
email: Irene.Cervello@ivi.es
facility: 
status: Recruiting
contact: 
country: Spain
citation: Cervello I, Gil-Sanchis C, Santamaria X, Cabanillas S, Diaz A, Faus A, Pellicer A, Simon C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.
PMID: 26384164
responsible party type: Sponsor
mesh term: Gynatresia