<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/NCT02254928</url>
  </required_header>
  <id_info>
    <org_study_id>MANCOR</org_study_id>
    <nct_id>NCT02254928</nct_id>
  </id_info>
  <brief_title>Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders</brief_title>
  <acronym>MANCOR</acronym>
  <official_title>Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Sevilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Valenciano de Infertilidad, IVI VALENCIA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IVI Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IVI Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IVI Sevilla</source>
  <brief_summary>
    <textblock>
      A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of&#xD;
      corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian&#xD;
      stimulation of women with a poor ovarian response undergoing IVF treatments. The main&#xD;
      objective of this study is comparing the number of oocytes obtained after the follicle&#xD;
      puncture when using each of these two stimulation protocols. Only poor responders according&#xD;
      to the Bologna criteria will be recruited for this trial. All participants will undergo two&#xD;
      stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will&#xD;
      be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the&#xD;
      order of application of these protocols will be randomised (crossover clinical trial) in each&#xD;
      patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of mature oocytes (metaphase II)</measure>
    <time_frame>1 year</time_frame>
    <description>Number of mature oocytes (metaphase II) obtained after the follicle puncture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of oocytes</measure>
    <time_frame>1 year</time_frame>
    <description>Total number of oocytes obtained after the follicle puncture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms associated with the ovarian stimulation protocol</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception of the stimulation treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of the stimulation treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Days of stimulation treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subcutaneous injections</measure>
    <time_frame>1 year</time_frame>
    <description>Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin alfa</intervention_name>
    <description>One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Elonva</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced maternal age (≥40 years)&#xD;
&#xD;
          -  A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)&#xD;
&#xD;
          -  An abnormal ovarian reserve test (i.e. antral follicle count &lt;5-7 follicles or&#xD;
             anti-mullerian hormone level &lt;0.5-1.1 ng/ml)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IVI Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Sevilla</name>
      <address>
        <city>Seville</city>
        <zip>41006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVI Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>January 15, 2016</last_update_submitted>
  <last_update_submitted_qc>January 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>poor ovarian response</keyword>
  <keyword>controlled ovarian stimulation</keyword>
  <keyword>randomised clinical trial</keyword>
  <keyword>corifollitropin alfa</keyword>
  <keyword>recombinant follicle-stimulating hormone (rFSH)</keyword>
  <keyword>human menopausal gonadotropin (HMG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT02254928
org study id: MANCOR
nct id: NCT02254928
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of
      corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian
      stimulation of women with a poor ovarian response undergoing IVF treatments. The main
      objective of this study is comparing the number of oocytes obtained after the follicle
      puncture when using each of these two stimulation protocols. Only poor responders according
      to the Bologna criteria will be recruited for this trial. All participants will undergo two
      stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will
      be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the
      order of application of these protocols will be randomised (crossover clinical trial) in each
      patient.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of mature oocytes (metaphase II)
time frame: 1 year
description: Number of mature oocytes (metaphase II) obtained after the follicle puncture
measure: Total number of oocytes
time frame: 1 year
description: Total number of oocytes obtained after the follicle puncture
measure: Symptoms associated with the ovarian stimulation protocol
time frame: 1 year
description: Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain.
measure: Patient perception of the stimulation treatment
time frame: 1 year
description: Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length.
measure: Length of the stimulation treatment
time frame: 1 year
description: Days of stimulation treatment
measure: Number of subcutaneous injections
time frame: 1 year
description: Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)
arm group label: Group 1
arm group type: Other
description: First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)
arm group label: Group 2
arm group type: Other
description: First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)
intervention type: Drug
intervention name: Corifollitropin alfa
description: One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.
arm group label: Group 1
arm group label: Group 2
other name: Elonva
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infertility