<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/NCT01709942</url>
  </required_header>
  <id_info>
    <org_study_id>C05</org_study_id>
    <nct_id>NCT01709942</nct_id>
  </id_info>
  <brief_title>Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)</brief_title>
  <official_title>Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Endocrinology and Reproductive Medicine, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Endocrinology and Reproductive Medicine, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a&#xD;
      unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian&#xD;
      hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For&#xD;
      this reason in this study the degarelix was tested in order to minimize the risk of OHSS as&#xD;
      well as to improve the pregnancy rate in these patients. The use of long acting GnRH&#xD;
      antagonist promotes a deep suppression of LH and consequently the activity of theca cells,&#xD;
      which secrete androgens (the precursors of estradiol), and consequently the levels of&#xD;
      estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle&#xD;
      with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in&#xD;
      order to establish the best way to perform controlled hyperstimulation in IVF cycles and&#xD;
      minimize the risk of OHSS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PREGNANCY RATE</measure>
    <time_frame>6 MONTHS</time_frame>
    <description>number of ongoing pregnancy obtained in the group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ovarian hyperstimulation syndrome rate</measure>
    <time_frame>6 MONTHS</time_frame>
    <description>incidence of ovarian hyperstimulation syndrome in the groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>implantation rate</measure>
    <time_frame>6 months</time_frame>
    <description>number of implanted embryos divided for the number of transferred embryos</description>
  </secondary_outcome>
  <other_outcome>
    <measure>number of mature oocytes</measure>
    <time_frame>6 months</time_frame>
    <description>number of mature oocytes obtained in each patient</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>PCOS</condition>
  <condition>OHSS</condition>
  <condition>INFERTILITY</condition>
  <arm_group>
    <arm_group_label>degarelix group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group of patients treated with long acting GnRH antagonist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cetrorelix 0.25mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>degarelix (long acting GnRH antagonist)</intervention_name>
    <description>20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration</description>
    <arm_group_label>degarelix group</arm_group_label>
    <other_name>Firmagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cetrorelix 0.25mg</intervention_name>
    <description>0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were &gt;300pg/ml</description>
    <arm_group_label>Cetrorelix 0.25mg</arm_group_label>
    <other_name>cetrotide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with PCOS&#xD;
&#xD;
          -  previous OHSS&#xD;
&#xD;
          -  Infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  more than 38 years old&#xD;
&#xD;
          -  Body mass index pore than 30&#xD;
&#xD;
          -  other systemic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Sbracia, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre for Endocrinology and Reproductive Medicine, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cerm-Hungaria</name>
      <address>
        <city>Rome</city>
        <zip>00153</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.</citation>
    <PMID>22197127</PMID>
  </results_reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 25, 2016</last_update_submitted>
  <last_update_submitted_qc>April 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Endocrinology and Reproductive Medicine, Italy</investigator_affiliation>
    <investigator_full_name>Fabio Scarpellini</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>GnRH antagonist</keyword>
  <keyword>PCOS</keyword>
  <keyword>OHSS</keyword>
  <keyword>COH</keyword>
  <keyword>IVF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetrorelix</mesh_term>
  </intervention_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/NCT01709942
org study id: C05
nct id: NCT01709942
lead sponsor: 
has dmc: Yes
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a
      unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian
      hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For
      this reason in this study the degarelix was tested in order to minimize the risk of OHSS as
      well as to improve the pregnancy rate in these patients. The use of long acting GnRH
      antagonist promotes a deep suppression of LH and consequently the activity of theca cells,
      which secrete androgens (the precursors of estradiol), and consequently the levels of
      estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle
      with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in
      order to establish the best way to perform controlled hyperstimulation in IVF cycles and
      minimize the risk of OHSS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: PREGNANCY RATE
time frame: 6 MONTHS
description: number of ongoing pregnancy obtained in the group
measure: ovarian hyperstimulation syndrome rate
time frame: 6 MONTHS
description: incidence of ovarian hyperstimulation syndrome in the groups
measure: implantation rate
time frame: 6 months
description: number of implanted embryos divided for the number of transferred embryos
measure: number of mature oocytes
time frame: 6 months
description: number of mature oocytes obtained in each patient
arm group label: degarelix group
arm group type: Experimental
description: group of patients treated with long acting GnRH antagonist
arm group label: Cetrorelix 0.25mg
arm group type: Active Comparator
description: patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
intervention type: Drug
intervention name: degarelix (long acting GnRH antagonist)
description: 20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
arm group label: degarelix group
other name: Firmagon
intervention type: Drug
intervention name: cetrorelix 0.25mg
description: 0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
arm group label: Cetrorelix 0.25mg
other name: cetrotide
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: No
last name: Marco Sbracia, MD
role: Study Chair
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
facility: 
country: Italy
citation: Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.
PMID: 22197127
responsible party type: Principal Investigator
investigator affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
investigator full name: Fabio Scarpellini
investigator title: Principal Investigator
mesh term: Infertility
mesh term: Cetrorelix