<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/NCT01715324</url>
  </required_header>
  <id_info>
    <org_study_id>OVO-09-03</org_study_id>
    <nct_id>NCT01715324</nct_id>
  </id_info>
  <brief_title>Adjuvant Growth Therapy in in Vitro Fertilization</brief_title>
  <official_title>Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EMD Serono</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinique Ovo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually&#xD;
      taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols&#xD;
      are constantly under review in order to improve the recruitment of the follicles, which&#xD;
      contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate&#xD;
      aim of increasing the live birth rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The addition of growth hormone, which is a biological hormone that can be synthetically&#xD;
      produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been&#xD;
      suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth&#xD;
      hormone has been shown, in animal and human studies, to be important in the recruitment of&#xD;
      follicles.However, to date, only a limited number of clinical studies have been performed in&#xD;
      order to assess whether the addition of growth hormone can improve the probability of&#xD;
      pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total&#xD;
      number of patients analysed in these studies was small it has not been possible to determine&#xD;
      whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a&#xD;
      woman is given growth hormone therapy as a supplement during her treatment.&#xD;
&#xD;
      This goal of this study is to determine the effectiveness of using growth hormone therapy as&#xD;
      a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">August 2021</completion_date>
  <primary_completion_date type="Actual">July 2021</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>Clinical pregnancy rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total dose of gonadotropins</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of observed follicles</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of mature (Metaphase II) oocytes retrieved</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oocyte morphology</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo morphology</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo cleavage rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of embryos available</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of supernumerary embryos available for cryopreservation</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>40 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>40 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse side effects in women</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">288</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Growth Hormon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant Growth Hormon</intervention_name>
    <description>The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering</description>
    <arm_group_label>Growth Hormon</arm_group_label>
    <other_name>Saizen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between the ages of 35 to 42&#xD;
&#xD;
          -  Primary or secondary infertility)&#xD;
&#xD;
               -  No previous treatment IVF cycle using the same proposed protocol&#xD;
&#xD;
          -  Negative pregnancy test at randomization (urine or blood)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to Saizen®&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial&#xD;
&#xD;
          -  follicle stimulating hormone &gt; 12 IU/L and/or anti-mullerian hormone &lt; 0.5 pg/ml&#xD;
&#xD;
          -  Body mass index ≥ 35 kg/m2&#xD;
&#xD;
          -  Known risk of gestational diabetes&#xD;
&#xD;
          -  Administration of any investigational medication three months prior to study enrolment&#xD;
&#xD;
          -  Positive results of screening for either partner for HIV antibodies, Hepatitis B&#xD;
             (other than surface antibodies present after vaccination) or Hepatitis C&#xD;
&#xD;
          -  Not able to communicate in French or English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Kadoch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Ovo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Ovo</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In vitro fertilization</keyword>
  <keyword>Antagonist protocol</keyword>
  <keyword>Growth Hormone</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/NCT01715324
org study id: OVO-09-03
nct id: NCT01715324
lead sponsor: 
collaborator: 
has dmc: Yes
In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually
      taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols
      are constantly under review in order to improve the recruitment of the follicles, which
      contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate
      aim of increasing the live birth rate.
The addition of growth hormone, which is a biological hormone that can be synthetically
      produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been
      suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth
      hormone has been shown, in animal and human studies, to be important in the recruitment of
      follicles.However, to date, only a limited number of clinical studies have been performed in
      order to assess whether the addition of growth hormone can improve the probability of
      pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total
      number of patients analysed in these studies was small it has not been possible to determine
      whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a
      woman is given growth hormone therapy as a supplement during her treatment.

      This goal of this study is to determine the effectiveness of using growth hormone therapy as
      a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization
      protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical pregnancy rate
time frame: 7 weeks
description: To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).
measure: Total dose of gonadotropins
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Number of observed follicles
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Number of mature (Metaphase II) oocytes retrieved
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Oocyte morphology
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Fertilization rate
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Embryo morphology
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Embryo cleavage rate
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Number of embryos available
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Number of supernumerary embryos available for cryopreservation
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Implantation rate
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Miscarriage rate
time frame: 40 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Live birth rate
time frame: 40 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
measure: Adverse side effects in women
time frame: 7 weeks
description: To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
arm group label: Growth Hormon
arm group type: Experimental
description: The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering.
arm group label: Control
arm group type: No Intervention
description: The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen).
intervention type: Drug
intervention name: Adjuvant Growth Hormon
description: The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering
arm group label: Growth Hormon
other name: Saizen
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 42 Years
healthy volunteers: No
last name: Jacques Kadoch, MD
role: Principal Investigator
affiliation: Clinique Ovo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infertility