<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/NCT02240342</url>
  </required_header>
  <id_info>
    <org_study_id>NEOFOL2014</org_study_id>
    <nct_id>NCT02240342</nct_id>
  </id_info>
  <brief_title>Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve</brief_title>
  <official_title>Ovarian Rejuvenation: Regeneration of Ovarian Follicles in Women With Poor Ovarian Reserve by Autologous Transplantation of Bone Marrow Derived Progenitors Cells in Peripheral Blood. Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Fe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women delay maternity and, as a consequence, available oocyte number and their quality&#xD;
      decrease (9-18% of all IVF patients). Different treatment protocols have been developed&#xD;
      nevertheless none of them optimal: the number of oocytes retrieved depends on the present&#xD;
      ones. New generation of oocytes and follicles has been defended by some authors and bone&#xD;
      marrow seems to be involved. What seems crucial is the niche that produces paracrine signals&#xD;
      able to activate dormant cells and to attract undifferentiated cells from other tissues&#xD;
      (homing). This phenomenon has been described by our group in other human reproductive tissues&#xD;
      like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women&#xD;
      with poor ovarian reserve by means of bone marrow protective capacity.&#xD;
&#xD;
      Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to&#xD;
      colonize ovarian niche.&#xD;
&#xD;
      The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve&#xD;
      differentiating themselves into germ cells or, more likely, stimulating the niche to activate&#xD;
      dormant follicles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2015</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>Ovarian reserve</measure>
    <time_frame>6 months</time_frame>
    <description>Measured by FSH-LH, oestradiol, AMH, antral follicle count</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ovarian response to controlled ovarian stimulation</measure>
    <time_frame>6 months</time_frame>
    <description>Number of MII oocytes obtained</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Take home baby</measure>
    <time_frame>2 years</time_frame>
    <description>healthy new born after controlled ovarian stimulation, ICSI and ET.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Ovarian Reserve</condition>
  <arm_group>
    <arm_group_label>Poor ovarian reserve women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bone marrow transplant into ovarian artery</intervention_name>
    <description>Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery</description>
    <arm_group_label>Poor ovarian reserve women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt; or= 40 years old&#xD;
&#xD;
          -  FSH&lt;15UI/L&#xD;
&#xD;
          -  poor ovarian response after controlled ovarian stimulation with conventional doses (&lt;3&#xD;
             oocytes) or two episodes of poor ovarian response after ovarian stimulation with&#xD;
             maximal doses even if young or normal ovarian reserve study.&#xD;
&#xD;
          -  Antral follicle count&gt;2&#xD;
&#xD;
          -  &gt;1 antral follicle in the perfused ovary&#xD;
&#xD;
          -  AMH between 0,5 and 3pmol/L&#xD;
&#xD;
          -  regular menstrual bleeding each 21-35 days&#xD;
&#xD;
          -  To be candidate to autologous hematopoietic progenitors transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Antonio Pellicer, Professor</last_name>
    <phone>+34961244000</phone>
    <phone_ext>245848</phone_ext>
    <email>pellicer_ant@gva.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario La fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susana Martínez, Doctor</last_name>
      <phone>+34961244000</phone>
      <phone_ext>244116</phone_ext>
      <email>susamc12@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Mónica Romeu, Doctor</last_name>
      <phone>+34961244000</phone>
      <phone_ext>244116</phone_ext>
      <email>monicaromeuvillarroya@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio Pellicer, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Dr. Antonio Pellicer Martínez</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Ovarian reserve</keyword>
  <keyword>Poor response</keyword>
  <keyword>Follicle recruitment</keyword>
  <keyword>Bone marrow transplant</keyword>
  <!-- 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/NCT02240342
org study id: NEOFOL2014
nct id: NCT02240342
lead sponsor: 
has dmc: No
Women delay maternity and, as a consequence, available oocyte number and their quality
      decrease (9-18% of all IVF patients). Different treatment protocols have been developed
      nevertheless none of them optimal: the number of oocytes retrieved depends on the present
      ones. New generation of oocytes and follicles has been defended by some authors and bone
      marrow seems to be involved. What seems crucial is the niche that produces paracrine signals
      able to activate dormant cells and to attract undifferentiated cells from other tissues
      (homing). This phenomenon has been described by our group in other human reproductive tissues
      like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women
      with poor ovarian reserve by means of bone marrow protective capacity.

      Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to
      colonize ovarian niche.

      The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve
      differentiating themselves into germ cells or, more likely, stimulating the niche to activate
      dormant follicles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ovarian reserve
time frame: 6 months
description: Measured by FSH-LH, oestradiol, AMH, antral follicle count
measure: Ovarian response to controlled ovarian stimulation
time frame: 6 months
description: Number of MII oocytes obtained
measure: Take home baby
time frame: 2 years
description: healthy new born after controlled ovarian stimulation, ICSI and ET.
arm group label: Poor ovarian reserve women
arm group type: Experimental
intervention type: Drug
intervention name: Bone marrow transplant into ovarian artery
description: Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery
arm group label: Poor ovarian reserve women
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Antonio Pellicer, Professor
phone: +34961244000
phone ext: 245848
email: pellicer_ant@gva.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Dr. Antonio Pellicer Martínez
investigator title: Professor