<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/NCT01723085</url>
  </required_header>
  <id_info>
    <org_study_id>AMH</org_study_id>
    <nct_id>NCT01723085</nct_id>
  </id_info>
  <brief_title>Anti-Mullerian Hormone Levels Before and After an Open Myomectomy</brief_title>
  <official_title>Anti-Mullerian Hormone Levels Variations Following an Open Myomectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Ovo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian&#xD;
      surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other&#xD;
      surgeries. We seek to investigate the hormone variations before and after an open myomectomy.&#xD;
&#xD;
      Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels&#xD;
      in a few months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    It has been put on hold for the moment due to logistic problems&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-Mullerian Hormone levels variation</measure>
    <time_frame>6 months</time_frame>
    <description>Anti-Mullerian Hormone levels before and 6 months after surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Anti-Mullerian Hormone</condition>
  <arm_group>
    <arm_group_label>Open myomectomy</arm_group_label>
    <description>All patients belong to the same group Description includes the surgical technique</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples collected to measure Anti-Mullerian hormone levels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women 18 to 42 tears old Indication for myomectomy by laparotomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 42 years old&#xD;
&#xD;
          -  Requiring open myomectomy for any indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapable of informed consent&#xD;
&#xD;
          -  Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3&#xD;
             months&#xD;
&#xD;
          -  Woman over 42 years old&#xD;
&#xD;
          -  Post-menopause women&#xD;
&#xD;
          -  Positive B-human chorionic gonadotropin the day of surgery&#xD;
&#xD;
          -  Ovarian surgery (at the same time)&#xD;
&#xD;
          -  Pre-operative AMH below 0.3 ng/mL&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Himaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Saint-Luc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anti-Mullerian hormone</keyword>
  <keyword>Myomectomy</keyword>
  <keyword>Laparotomy</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/NCT01723085
org study id: AMH
nct id: NCT01723085
lead sponsor: 
has dmc: No
Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian
      surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other
      surgeries. We seek to investigate the hormone variations before and after an open myomectomy.

      Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels
      in a few months
observational model: Cohort
time perspective: Prospective
measure: Anti-Mullerian Hormone levels variation
time frame: 6 months
description: Anti-Mullerian Hormone levels before and 6 months after surgery
arm group label: Open myomectomy
description: All patients belong to the same group Description includes the surgical technique
Blood samples collected to measure Anti-Mullerian hormone levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Eric Himaya, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
responsible party type: Sponsor