<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/NCT02213627</url>
  </required_header>
  <id_info>
    <org_study_id>1403-MAD-013-AR</org_study_id>
    <nct_id>NCT02213627</nct_id>
  </id_info>
  <brief_title>Use of Corifolitropin Alfa in Oocyte Donors</brief_title>
  <official_title>Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Madrid</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>Instituto Valenciano de Infertilidad, IVI Alicante</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IVI Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin&#xD;
      administration) is effective in a controlled ovarian stimulation protocol in oocyte donors&#xD;
      compared to daily gonadotropin administration (recombinant FSH or HP-hMG)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, increasingly advances have been developed in terms of controlled ovarian&#xD;
      stimulation protocols. These improvements have also moved into the way of administration of&#xD;
      the different treatments, and at present, with subcutaneous devices, it is possible to offer&#xD;
      advantages such as the ability to ensure administration of the correct dose or modify the&#xD;
      dose before charging.&#xD;
&#xD;
      Simplification of ovarian stimulation protocols can help to reduce physical stress of the&#xD;
      donors and the cancellation rate. The need for daily injection does not worsen the degree of&#xD;
      compliance, but it generates some anxiety related to the administration of the right dose and&#xD;
      / or the possibility of making a unconsciously mistake . Innovations in delivery devices&#xD;
      could help reduce the stress associated with the stimulation itself and improve the welfare&#xD;
      of the donor. Given these considerations, the need to develop a stimulation protocol that&#xD;
      reduces the physical and emotional burden of reproduction treatment is established.&#xD;
&#xD;
      Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect&#xD;
      of stimulation; a single subcutaneous injection of this drug is able to replace the first&#xD;
      seven injections of any daily FSH preparation, so finally, the result would be an overall&#xD;
      decrease in the number of injections needed for the whole cycle. Pharmacological and&#xD;
      pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple&#xD;
      stimulation protocols and the need for fewer resources when monitoring the donor, including&#xD;
      fewer clinic visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of oocytes and mature oocytes</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization and implantation rates</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop-out rate and cancellation rate</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness analysis</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endocrine profile in serum and follicular fluid</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apoptosis rate in cumulus cells</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Female Reproductive Problem</condition>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Corifollitropin alfa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recombinant FSH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HP-hMG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin alfa</intervention_name>
    <arm_group_label>Corifollitropin alfa</arm_group_label>
    <other_name>Elonva 100 micrograms</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant FSH</intervention_name>
    <arm_group_label>Recombinant FSH</arm_group_label>
    <other_name>Puregon 50 IU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HP-hMG</intervention_name>
    <arm_group_label>HP-hMG</arm_group_label>
    <other_name>Menopur 600 IU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:&#xD;
&#xD;
          -  Weight &lt; 60 Kg&#xD;
&#xD;
          -  Women with at least 6 antral follicles per ovary&#xD;
&#xD;
          -  Women who will fit the protocoo during the period of the study&#xD;
&#xD;
          -  Women who give written consent to participate in the test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with basal antral follicle count above 20 or below 6.&#xD;
&#xD;
          -  Women with comorbidities, in the judgement of the investigator, that may interfere&#xD;
             with the trearment of ovarian stimulation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Requena, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Muñoz, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Valenciano de Infertilidad, IVI Alicante</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pilar Alamá, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IVI Valencia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María Cruz, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>IVI Madrid</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Antonio Requena, MD, PhD</last_name>
    <phone>+34 911802900</phone>
    <email>Antonio.Requena@ivi.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>María Cruz, PhD</last_name>
    <phone>+34 911802900</phone>
    <email>Maria.Cruz@ivi.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IVI Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Requena, MD, PhD</last_name>
      <phone>+34 911802900</phone>
      <email>Antonio.Requena@ivi.es</email>
    </contact>
    <contact_backup>
      <last_name>María Cruz, PhD</last_name>
      <phone>+34 911802900</phone>
      <email>Maria.Cruz@ivi.es</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio Requena, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>María Cruz, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>July 16, 2015</last_update_submitted>
  <last_update_submitted_qc>July 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IVI Madrid</investigator_affiliation>
    <investigator_full_name>Antonio Requena</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Corifollitropin alfa, recombinant FSH, HP-hMG, apoptosis, oocyte donation</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>Menotropins</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>July 21, 2016</submitted>
    <returned>September 2, 2016</returned>
  </pending_results>
  <!-- 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/NCT02213627
org study id: 1403-MAD-013-AR
nct id: NCT02213627
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin
      administration) is effective in a controlled ovarian stimulation protocol in oocyte donors
      compared to daily gonadotropin administration (recombinant FSH or HP-hMG)
In recent years, increasingly advances have been developed in terms of controlled ovarian
      stimulation protocols. These improvements have also moved into the way of administration of
      the different treatments, and at present, with subcutaneous devices, it is possible to offer
      advantages such as the ability to ensure administration of the correct dose or modify the
      dose before charging.

      Simplification of ovarian stimulation protocols can help to reduce physical stress of the
      donors and the cancellation rate. The need for daily injection does not worsen the degree of
      compliance, but it generates some anxiety related to the administration of the right dose and
      / or the possibility of making a unconsciously mistake . Innovations in delivery devices
      could help reduce the stress associated with the stimulation itself and improve the welfare
      of the donor. Given these considerations, the need to develop a stimulation protocol that
      reduces the physical and emotional burden of reproduction treatment is established.

      Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect
      of stimulation; a single subcutaneous injection of this drug is able to replace the first
      seven injections of any daily FSH preparation, so finally, the result would be an overall
      decrease in the number of injections needed for the whole cycle. Pharmacological and
      pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple
      stimulation protocols and the need for fewer resources when monitoring the donor, including
      fewer clinic visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of oocytes and mature oocytes
time frame: 3 months
measure: Fertilization and implantation rates
time frame: 3 months
measure: Drop-out rate and cancellation rate
time frame: 3 months
measure: Cost-effectiveness analysis
time frame: 6 months
measure: Endocrine profile in serum and follicular fluid
time frame: 3 months
measure: Apoptosis rate in cumulus cells
time frame: 6 months
arm group label: Corifollitropin alfa
arm group type: Experimental
description: From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.
arm group label: Recombinant FSH
arm group type: Experimental
description: From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.
arm group label: HP-hMG
arm group type: Experimental
description: From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.
intervention type: Drug
intervention name: Corifollitropin alfa
arm group label: Corifollitropin alfa
other name: Elonva 100 micrograms
intervention type: Drug
intervention name: Recombinant FSH
arm group label: Recombinant FSH
other name: Puregon 50 IU
intervention type: Drug
intervention name: HP-hMG
arm group label: HP-hMG
other name: Menopur 600 IU
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antonio Requena, MD, PhD
role: Principal Investigator
affiliation: IVI Madrid
last name: Manuel Muñoz, MD, PhD
role: Study Chair
affiliation: Instituto Valenciano de Infertilidad, IVI Alicante
last name: Pilar Alamá, MD, PhD
role: Study Chair
affiliation: IVI Valencia
last name: María Cruz, PhD
role: Study Chair
affiliation: IVI Madrid
last name: Antonio Requena, MD, PhD
phone: +34 911802900
email: Antonio.Requena@ivi.es
last name: María Cruz, PhD
phone: +34 911802900
email: Maria.Cruz@ivi.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: IVI Madrid
investigator full name: Antonio Requena
investigator title: MD, PhD
mesh term: Infertility
mesh term: Menotropins
submitted: July 21, 2016
returned: September 2, 2016