<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/NCT02244866</url>
  </required_header>
  <id_info>
    <org_study_id>NCKH/CGRH_01_2012</org_study_id>
    <nct_id>NCT02244866</nct_id>
  </id_info>
  <brief_title>Efficacy of Pergoveris in Aged IVF Patients</brief_title>
  <official_title>A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vietnam National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vietnam National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation&#xD;
      (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.&#xD;
&#xD;
      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH&#xD;
      supplementation) for ovarian stimulation in aged IVF patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled single center study.&#xD;
&#xD;
      Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment&#xD;
      groups, with and without LH supplementation, in a previous study, with 90% power and a&#xD;
      2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The&#xD;
      recruitment target was 120 subjects per group (total 240) to allow for dropouts.&#xD;
&#xD;
      Eligible subjects were randomized in blocks of 4 via a computer generated random number list&#xD;
      to either the Pergoveris arm or the follitropin alpha arm.&#xD;
&#xD;
      Ovarian stimulation was performed by using GnRH antagonist protocol.&#xD;
&#xD;
      Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle.&#xD;
      The first FSH dose was determined according to each individual patient, based on the process&#xD;
      as follows:&#xD;
&#xD;
        -  AFC ≤ 6: 300 IU/day&#xD;
&#xD;
        -  AFC 7-15: 225 IU/day&#xD;
&#xD;
        -  AFC ≥ 16: 150 IU/day&#xD;
&#xD;
      GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.&#xD;
&#xD;
        -  Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH&#xD;
           administration. Patients in the Pergoveris group would be administered a reduced dose of&#xD;
           recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH +&#xD;
           75IU LH)/day.&#xD;
&#xD;
        -  The Follitropin alpha group retained recombinant FSH. In both groups, if the number of&#xD;
           developing follicles was inappropriate, the dose could be titrated depending on the&#xD;
           physician's judgment.&#xD;
&#xD;
      Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying&#xD;
      LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of&#xD;
      the hospital.&#xD;
&#xD;
      OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were&#xD;
      transferred on day 2.&#xD;
&#xD;
      Luteal phase support: daily vaginal progesterone&#xD;
&#xD;
      Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer.&#xD;
      Beta hCG &gt; 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a&#xD;
      positive pregnancy test to verify clinical pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Clinical pregnancy</measure>
    <time_frame>7 weeks after embryo transfer</time_frame>
    <description>Clinical pregnancy is defined by the image gestational sac under ultrasonography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Live birth</measure>
    <time_frame>at the time of delivery</time_frame>
    <description>Live birth is defined if a live newborn delivered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total FSH international units (IU) used for stimulation</measure>
    <time_frame>Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days</time_frame>
    <description>Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Pergoveris (FSH and LH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Follitropin alpha (FSH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pergoveris (FSH and LH)</intervention_name>
    <description>Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.</description>
    <arm_group_label>Pergoveris (FSH and LH)</arm_group_label>
    <other_name>Pergoveris</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin alpha (FSH)</intervention_name>
    <description>Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.</description>
    <arm_group_label>Follitropin alpha (FSH)</arm_group_label>
    <other_name>Gonal-F</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 35 years&#xD;
&#xD;
          -  body mass index &lt;28 kg/m2&#xD;
&#xD;
          -  had ≤ 3 previous IVF attempts&#xD;
&#xD;
          -  receiving a GnRH-antagonist protocol&#xD;
&#xD;
          -  agreement to participate in the study, and to disclose any medical events to the&#xD;
             investigator. The subject must be willing and able to comply with the protocol&#xD;
             requirements for the duration of the study.&#xD;
&#xD;
          -  have given written informed consent with the understanding that the subject may&#xD;
             withdraw consent at any time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participating in another interventional clinical trial&#xD;
&#xD;
          -  PCOS or WHO group 1&#xD;
&#xD;
          -  have uterine abnormalities&#xD;
&#xD;
          -  have endocrine disorders such as hyperprolactinemia, thyroid disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuong M Ho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CGRH, School of Medicine, Vietnam National University HCMC, Vietnam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>An Sinh Hospital</name>
      <address>
        <city>Ho Chi Minh</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>December 23, 2014</last_update_submitted>
  <last_update_submitted_qc>December 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vietnam National University</investigator_affiliation>
    <investigator_full_name>Manh Tuong Ho</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>LH supplementation</keyword>
  <keyword>ovarian stimulation</keyword>
  <keyword>poor responder</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>Follicle Stimulating Hormone</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/NCT02244866
org study id: NCKH/CGRH_01_2012
nct id: NCT02244866
lead sponsor: 
has dmc: No
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation
      (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.

      Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH
      supplementation) for ovarian stimulation in aged IVF patients.
A randomized controlled single center study.

      Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment
      groups, with and without LH supplementation, in a previous study, with 90% power and a
      2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The
      recruitment target was 120 subjects per group (total 240) to allow for dropouts.

      Eligible subjects were randomized in blocks of 4 via a computer generated random number list
      to either the Pergoveris arm or the follitropin alpha arm.

      Ovarian stimulation was performed by using GnRH antagonist protocol.

      Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle.
      The first FSH dose was determined according to each individual patient, based on the process
      as follows:

        -  AFC ≤ 6: 300 IU/day

        -  AFC 7-15: 225 IU/day

        -  AFC ≥ 16: 150 IU/day

      GnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.

        -  Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH
           administration. Patients in the Pergoveris group would be administered a reduced dose of
           recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH +
           75IU LH)/day.

        -  The Follitropin alpha group retained recombinant FSH. In both groups, if the number of
           developing follicles was inappropriate, the dose could be titrated depending on the
           physician's judgment.

      Monitoring the follicular development was performed by vaginal ultrasound probe, quantifying
      LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of
      the hospital.

      OPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were
      transferred on day 2.

      Luteal phase support: daily vaginal progesterone

      Pregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer.
      Beta hCG > 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a
      positive pregnancy test to verify clinical pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical pregnancy
time frame: 7 weeks after embryo transfer
description: Clinical pregnancy is defined by the image gestational sac under ultrasonography.
measure: Live birth
time frame: at the time of delivery
description: Live birth is defined if a live newborn delivered.
measure: Total FSH international units (IU) used for stimulation
time frame: Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days
description: Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.
arm group label: Pergoveris (FSH and LH)
arm group type: Active Comparator
description: 150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection
arm group label: Follitropin alpha (FSH)
arm group type: Active Comparator
description: 150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection
intervention type: Drug
intervention name: Pergoveris (FSH and LH)
description: Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
arm group label: Pergoveris (FSH and LH)
other name: Pergoveris
intervention type: Drug
intervention name: Follitropin alpha (FSH)
description: Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
arm group label: Follitropin alpha (FSH)
other name: Gonal-F
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 45 Years
healthy volunteers: No
last name: Tuong M Ho, MD
role: Principal Investigator
affiliation: CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Vietnam National University
investigator full name: Manh Tuong Ho
investigator title: Doctor
mesh term: Infertility
mesh term: Follicle Stimulating Hormone