<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/NCT03816670</url>
  </required_header>
  <id_info>
    <org_study_id>IIS#53736</org_study_id>
    <nct_id>NCT03816670</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF</brief_title>
  <official_title>Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard&#xD;
      CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also&#xD;
      performed in specific subgroups of patients: expected poor-responders, expected normal&#xD;
      responders and expected hyper-responders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that:&#xD;
&#xD;
        1. CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved&#xD;
           oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa&#xD;
           late start might show differences in terms of efficacy such as in poor-responder&#xD;
           patients.&#xD;
&#xD;
        2. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates&#xD;
           with a similar safety profile with respect to COS performed using CF-alfa standard&#xD;
           administration (day 2) in expected normal, poor, or high responders.&#xD;
&#xD;
        3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological&#xD;
           features and development potential than those obtained with CF-alfa standard.&#xD;
&#xD;
        4. The patients' satisfaction will possibly be higher using CF-alfa late start than with&#xD;
           CF-alfa standard expecially in those patients who will not have the need to add further&#xD;
           daily recFSH injections&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</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 retrieved oocytes</measure>
    <time_frame>1 year</time_frame>
    <description>To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Fertility Disorders</condition>
  <arm_group>
    <arm_group_label>poor responders day 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;poor responders&quot; women stimulated with CF from day 2 of menstrual cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>poor responders day 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;poor responders&quot; women stimulated with CF from day 4 of menstrual cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal responders day 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;normal responders&quot; women stimulated with CF from day 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal responders day 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;normal responders&quot; women stimulated with CF from day 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high responders day 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;high responders&quot; women stimulated with CF from day 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high responders day 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>&quot;high responders&quot; women stimulated with CF from day 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corifollitropin Alfa</intervention_name>
    <description>late start (day 4) vs. corifollitropin-alfa standard start (day 2)</description>
    <arm_group_label>high responders day 2</arm_group_label>
    <arm_group_label>high responders day 4</arm_group_label>
    <arm_group_label>normal responders day 2</arm_group_label>
    <arm_group_label>normal responders day 4</arm_group_label>
    <arm_group_label>poor responders day 2</arm_group_label>
    <arm_group_label>poor responders day 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18- 43 years&#xD;
&#xD;
          -  Male or tubal infertility with indication for IVF treatment&#xD;
&#xD;
          -  No PCOS&#xD;
&#xD;
          -  No previous IVF treatments in the past two months&#xD;
&#xD;
          -  No history of previous Ovarian Hyperstimulation Syndrome (OHSS)&#xD;
&#xD;
          -  No previous IVF cycle with more than 30 growing follicles ≥ 11 mm&#xD;
&#xD;
          -  Antral Follicle Count (AFC) &lt;20&#xD;
&#xD;
          -  No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AMH &lt; 0.2 ng/ml&#xD;
&#xD;
          -  Età &gt; 43 anni&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Physiopathology of Reproduction and IVF Unit, S. Anna Hospital</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Alberto Revelli</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03816670
org study id: IIS#53736
nct id: NCT03816670
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard
      CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also
      performed in specific subgroups of patients: expected poor-responders, expected normal
      responders and expected hyper-responders
The investigators hypothesize that:

        1. CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved
           oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa
           late start might show differences in terms of efficacy such as in poor-responder
           patients.

        2. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates
           with a similar safety profile with respect to COS performed using CF-alfa standard
           administration (day 2) in expected normal, poor, or high responders.

        3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological
           features and development potential than those obtained with CF-alfa standard.

        4. The patients' satisfaction will possibly be higher using CF-alfa late start than with
           CF-alfa standard expecially in those patients who will not have the need to add further
           daily recFSH injections
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of retrieved oocytes
time frame: 1 year
description: To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF
arm group label: poor responders day 2
arm group type: Experimental
description: "poor responders" women stimulated with CF from day 2 of menstrual cycle
arm group label: poor responders day 4
arm group type: Experimental
description: "poor responders" women stimulated with CF from day 4 of menstrual cycle
arm group label: normal responders day 2
arm group type: Experimental
description: "normal responders" women stimulated with CF from day 2
arm group label: normal responders day 4
arm group type: Experimental
description: "normal responders" women stimulated with CF from day 4
arm group label: high responders day 2
arm group type: Experimental
description: "high responders" women stimulated with CF from day 2
arm group label: high responders day 4
arm group type: Experimental
description: "high responders" women stimulated with CF from day 4
intervention type: Drug
intervention name: Corifollitropin Alfa
description: late start (day 4) vs. corifollitropin-alfa standard start (day 2)
arm group label: high responders day 2
arm group label: high responders day 4
arm group label: normal responders day 2
arm group label: normal responders day 4
arm group label: poor responders day 2
arm group label: poor responders day 4
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Alberto Revelli
investigator title: Professor
sharing ipd: No