<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/NCT01682642</url>
  </required_header>
  <id_info>
    <org_study_id>2012-000784-25</org_study_id>
    <nct_id>NCT01682642</nct_id>
  </id_info>
  <brief_title>The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.</brief_title>
  <official_title>IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AZ Jan Palfijn Gent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AZ Jan Palfijn Gent</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study of endometriosis patients we compare a common treatment of surgical therapy and&#xD;
      medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In&#xD;
      both cases they immediately start In Vitro Fertilization (IVF) treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Metaphase II Cells (MII)</measure>
    <time_frame>3 weeks</time_frame>
    <description>number of MII cells retrieved</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of ongoing pregnancies obtained which still is the most important issue for the patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Good Embryo Quality</measure>
    <time_frame>3 days after oocyte retrieval</time_frame>
    <description>The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Pro Nuclear Cell (2PN)</measure>
    <time_frame>1 day after oocyte retrieval</time_frame>
    <description>number of 2PN</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cryopreserved Embryos</measure>
    <time_frame>1 week after oocyte retrieval</time_frame>
    <description>number of blastocytes that can be cryopreserved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Follicle Stimulating Hormone (FSH) Dose</measure>
    <time_frame>3 weeks</time_frame>
    <description>total dose of FSH needed at the end of stimulation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Days of Stimulation</measure>
    <time_frame>3 weeks</time_frame>
    <description>number of days needed before follicles in the ovary are mature for oocyte retrieval</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Infertility</condition>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Zoladex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaporization only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoladex</intervention_name>
    <description>after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment</description>
    <arm_group_label>Zoladex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laparoscopical vaporization of endometriosis&#xD;
&#xD;
          -  1,2, 3e IVF cycle&#xD;
&#xD;
          -  endometriosis stage I and II&#xD;
&#xD;
          -  younger than 38 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endometriosis cysts&#xD;
&#xD;
          -  uterine pathology&#xD;
&#xD;
          -  endocrinological diseases and problems&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wim Decleer, gynecologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fertility Center AZ Jan Palfijn Gent</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Devroey, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Fertility Center AZ Jan Palfijn Gent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Jan Palfijn</name>
      <address>
        <city>Gent</city>
        <state>Oost-vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>February 5, 2015</results_first_submitted>
  <results_first_submitted_qc>March 9, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 20, 2015</results_first_posted>
  <last_update_submitted>March 9, 2015</last_update_submitted>
  <last_update_submitted_qc>March 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AZ Jan Palfijn Gent</investigator_affiliation>
    <investigator_full_name>Dr. Decleer Wim</investigator_full_name>
    <investigator_title>gynecologist</investigator_title>
  </responsible_party>
  <keyword>endometriosis</keyword>
  <keyword>pregnancy</keyword>
  <keyword>In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI)</keyword>
  <keyword>peritoneal implants</keyword>
  <keyword>embryo quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Goserelin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zoladex</title>
          <description>After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.</description>
        </group>
        <group group_id="P2">
          <title>Vaporization Only</title>
          <description>After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>women between 18 and 38 years</population>
      <group_list>
        <group group_id="B1">
          <title>Zoladex</title>
          <description>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.&#xD;
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment</description>
        </group>
        <group group_id="B2">
          <title>Vaporization Only</title>
          <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="61"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.33" spread="3.63"/>
                    <measurement group_id="B2" value="31.70" spread="4.28"/>
                    <measurement group_id="B3" value="31.02" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Metaphase II Cells (MII)</title>
        <description>number of MII cells retrieved</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.&#xD;
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Metaphase II Cells (MII)</title>
          <description>number of MII cells retrieved</description>
          <units>MII cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="5.92"/>
                    <measurement group_id="O2" value="8.2" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pregnancy Rate</title>
        <description>The number of ongoing pregnancies obtained which still is the most important issue for the patients.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.&#xD;
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Pregnancy Rate</title>
          <description>The number of ongoing pregnancies obtained which still is the most important issue for the patients.</description>
          <units>percentage of ongoing pregnancies</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3"/>
                    <measurement group_id="O2" value="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Good Embryo Quality</title>
        <description>The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.</description>
        <time_frame>3 days after oocyte retrieval</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Good Embryo Quality</title>
          <description>The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.</description>
          <units>percentage of good quality embryos</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.3"/>
                    <measurement group_id="O2" value="67.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Pro Nuclear Cell (2PN)</title>
        <description>number of 2PN</description>
        <time_frame>1 day after oocyte retrieval</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Pro Nuclear Cell (2PN)</title>
          <description>number of 2PN</description>
          <units>number of pro nuclear cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="4.03"/>
                    <measurement group_id="O2" value="5.6" spread="4.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cryopreserved Embryos</title>
        <description>number of blastocytes that can be cryopreserved</description>
        <time_frame>1 week after oocyte retrieval</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cryopreserved Embryos</title>
          <description>number of blastocytes that can be cryopreserved</description>
          <units>number of cryopreserved embryos</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.40"/>
                    <measurement group_id="O2" value="1.6" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Days of Stimulation</title>
        <description>number of days needed before follicles in the ovary are mature for oocyte retrieval</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days of Stimulation</title>
          <description>number of days needed before follicles in the ovary are mature for oocyte retrieval</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="1.86"/>
                    <measurement group_id="O2" value="11.3" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Follicle Stimulating Hormone (FSH) Dose</title>
        <description>total dose of FSH needed at the end of stimulation</description>
        <time_frame>3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zoladex</title>
            <description>After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.</description>
          </group>
          <group group_id="O2">
            <title>Vaporization Only</title>
            <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Follicle Stimulating Hormone (FSH) Dose</title>
          <description>total dose of FSH needed at the end of stimulation</description>
          <units>IUs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2561" spread="621.7"/>
                    <measurement group_id="O2" value="2303" spread="604.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Zoladex</title>
          <description>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.&#xD;
Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment</description>
        </group>
        <group group_id="E2">
          <title>Vaporization Only</title>
          <description>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>OHSS</sub_title>
                <description>Ovary Hyper Stimulation Syndrome (OHSS)</description>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>miscarriage</sub_title>
                <description>pregnancy lost in first trimester</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>dr. Wim Decleer, PI</name_or_title>
      <organization>Fertility Center AZ Jan Palfijn</organization>
      <phone>0032 9 325 92 20 ext 09/2248851</phone>
      <email>wim.decleer@janpalfijngent.be</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01682642
org study id: 2012-000784-25
nct id: NCT01682642
lead sponsor: 
collaborator: 
has dmc: Yes
In this study of endometriosis patients we compare a common treatment of surgical therapy and
      medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In
      both cases they immediately start In Vitro Fertilization (IVF) treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Metaphase II Cells (MII)
time frame: 3 weeks
description: number of MII cells retrieved
measure: Pregnancy Rate
time frame: 12 weeks
description: The number of ongoing pregnancies obtained which still is the most important issue for the patients.
measure: Good Embryo Quality
time frame: 3 days after oocyte retrieval
description: The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.
measure: Number of Pro Nuclear Cell (2PN)
time frame: 1 day after oocyte retrieval
description: number of 2PN
measure: Number of Cryopreserved Embryos
time frame: 1 week after oocyte retrieval
description: number of blastocytes that can be cryopreserved
measure: Total Follicle Stimulating Hormone (FSH) Dose
time frame: 3 weeks
description: total dose of FSH needed at the end of stimulation
measure: Number of Days of Stimulation
time frame: 3 weeks
description: number of days needed before follicles in the ovary are mature for oocyte retrieval
arm group label: Zoladex
arm group type: Active Comparator
description: After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
arm group label: vaporization only
arm group type: No Intervention
description: Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
intervention type: Drug
intervention name: Zoladex
description: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
arm group label: Zoladex
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Wim Decleer, gynecologist
role: Principal Investigator
affiliation: Fertility Center AZ Jan Palfijn Gent
last name: Paul Devroey, Professor
role: Study Chair
affiliation: Fertility Center AZ Jan Palfijn Gent
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: AZ Jan Palfijn Gent
investigator full name: Dr. Decleer Wim
investigator title: gynecologist
mesh term: Infertility
mesh term: Endometriosis
mesh term: Goserelin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 