<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/NCT01690858</url>
  </required_header>
  <id_info>
    <org_study_id>10/6-K</org_study_id>
    <nct_id>NCT01690858</nct_id>
  </id_info>
  <brief_title>Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions</brief_title>
  <official_title>Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the role of complement dysregulation and its impact on&#xD;
      antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Females with medical history of repeated foetal losses will have blood sampling to perform&#xD;
      analyses. If pregnant, blood sampling will be performed at different times throughout the&#xD;
      pregnancy.&#xD;
&#xD;
      Controls will be females without medical history of repeated foetal losses. They will also&#xD;
      have blood sampling to perform analyses. If pregnant, blood sampling will be performed at&#xD;
      different times throughout the pregnancy.&#xD;
&#xD;
      Blood analyses will focus on :&#xD;
&#xD;
        -  mutations in genes coding for molecules that modulate complement activity&#xD;
&#xD;
        -  serum levels of sFlt1 and endoglin and their link to complement activation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>mutations in genes coding for molecules that modulate complement activity</measure>
    <time_frame>day1 (at inclusion)</time_frame>
    <description>to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum levels of sFlt1 and endoglin and their link to complement activation markers</measure>
    <time_frame>4 weeks post pregnancy start</time_frame>
    <description>To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum levels of sFlt1 and endoglin and their link to complement activation</measure>
    <time_frame>8 weeks post pregnancy start</time_frame>
    <description>To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum levels of sFlt1 and endoglin and their link to complement activation</measure>
    <time_frame>16 weeks post pregnancy start</time_frame>
    <description>To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum levels of sFlt1 and endoglin and their link to complement activation</measure>
    <time_frame>24 weeks post pregnancy start</time_frame>
    <description>To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Fetal Losses</condition>
  <arm_group>
    <arm_group_label>females with medical history of repeated foetal losses</arm_group_label>
    <description>The females can be pregnant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>females without medical history of repeated foetal losses</arm_group_label>
    <description>The females can be pregnant</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <description>blood sampling at inclusion and throughout pregnancy when pregnant</description>
    <arm_group_label>females with medical history of repeated foetal losses</arm_group_label>
    <arm_group_label>females without medical history of repeated foetal losses</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Females with medical history of repeated foetal losses and females without medical history&#xD;
        of repeated foetal losses as controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for females with repeated fetal losses:&#xD;
&#xD;
          -  Age&gt; 18&#xD;
&#xD;
          -  Female affiliated to French health insurance (Social Security),&#xD;
&#xD;
          -  Informed consent form signed&#xD;
&#xD;
          -  Patient with history of at least three foetal losses without any cause found&#xD;
             (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)&#xD;
&#xD;
        Exclusion criteria for females with repeated fetal losses :&#xD;
&#xD;
          -  Patient not fulfilling inclusion criteria&#xD;
&#xD;
          -  Age &gt; 40&#xD;
&#xD;
          -  Female unable to understand benefits and risks of protocol&#xD;
&#xD;
          -  Female with history of repeated foetal losses of infectious or endocrine origin.&#xD;
&#xD;
        Inclusion criteria for females without repeated fetal losses:&#xD;
&#xD;
          -  Age&gt; 18&#xD;
&#xD;
          -  Female affiliated to the French health insurance (Social Security)&#xD;
&#xD;
          -  Informed consent form signed&#xD;
&#xD;
          -  Female without history of repeated foetal losses&#xD;
&#xD;
        Exclusion criteria for females without repeated fetal losses:&#xD;
&#xD;
          -  Patient not fulfilling inclusion criteria&#xD;
&#xD;
          -  Female with age above 40&#xD;
&#xD;
          -  Female unable to understand benefits and risks of protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antoine Beclere Hospital (AP-HP)</name>
      <address>
        <city>Clamart</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>November 29, 2011</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Foetal loss</keyword>
  <keyword>complement</keyword>
  <keyword>antiangiogenic factors</keyword>
  <keyword>Repeated fetal losses</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/NCT01690858
org study id: 10/6-K
nct id: NCT01690858
lead sponsor: 
has dmc: No
The aim of the study is to assess the role of complement dysregulation and its impact on
      antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.
Females with medical history of repeated foetal losses will have blood sampling to perform
      analyses. If pregnant, blood sampling will be performed at different times throughout the
      pregnancy.

      Controls will be females without medical history of repeated foetal losses. They will also
      have blood sampling to perform analyses. If pregnant, blood sampling will be performed at
      different times throughout the pregnancy.

      Blood analyses will focus on :

        -  mutations in genes coding for molecules that modulate complement activity

        -  serum levels of sFlt1 and endoglin and their link to complement activation
observational model: Case-Control
time perspective: Prospective
measure: mutations in genes coding for molecules that modulate complement activity
time frame: day1 (at inclusion)
description: to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.
measure: serum levels of sFlt1 and endoglin and their link to complement activation markers
time frame: 4 weeks post pregnancy start
description: To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
measure: serum levels of sFlt1 and endoglin and their link to complement activation
time frame: 8 weeks post pregnancy start
description: To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
measure: serum levels of sFlt1 and endoglin and their link to complement activation
time frame: 16 weeks post pregnancy start
description: To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
measure: serum levels of sFlt1 and endoglin and their link to complement activation
time frame: 24 weeks post pregnancy start
description: To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
arm group label: females with medical history of repeated foetal losses
description: The females can be pregnant
arm group label: females without medical history of repeated foetal losses
description: The females can be pregnant
intervention type: Other
intervention name: blood sample
description: blood sampling at inclusion and throughout pregnancy when pregnant
arm group label: females with medical history of repeated foetal losses
arm group label: females without medical history of repeated foetal losses
blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: France
responsible party type: Sponsor