<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/NCT02208986</url>
  </required_header>
  <id_info>
    <org_study_id>NCKH/CGRH_01_2014</org_study_id>
    <nct_id>NCT02208986</nct_id>
  </id_info>
  <brief_title>GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study</brief_title>
  <official_title>GnRHa Trigger in Asian Oocyte Donors Co-treated With a GnRH Antagonist - a Dose Finding Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vietnam National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fertility Clinic, Skive Regional Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vietnam National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized single center study is to explore the most optimal dose of GnRHa&#xD;
      used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte&#xD;
      donors who have GnRHa trigger as a standard trigger concept.&#xD;
&#xD;
      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa&#xD;
      will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality&#xD;
      embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of&#xD;
      the dose of GnRHa used for trigger.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods&#xD;
&#xD;
      A randomized controlled single center study. All oocyte donors, fulfilling the inclusion&#xD;
      criteria, will be eligible for inclusion after randomization.&#xD;
&#xD;
      Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day&#xD;
      two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) -&#xD;
      donors will be randomized to one of three groups, using different doses of GnRHa&#xD;
      (Triptorelin) for trigger. Stimulation will be performed according to the standard&#xD;
      stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH&#xD;
      antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either&#xD;
      100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan&#xD;
      (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon&#xD;
      as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be&#xD;
      performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the&#xD;
      trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34&#xD;
      hours, according to the usual practice of the clinic. Importantly, each patient will be asked&#xD;
      to check the presence of an LH surge via a urine LH detection kit at 4 hours after the&#xD;
      trigger bolus has been administered. Embryo transfer will be performed on day two in all&#xD;
      recipients.&#xD;
&#xD;
      Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg&#xD;
      Triptorelin. All other procedures will be performed according to the practice of the clinic.&#xD;
&#xD;
      Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg&#xD;
      Triptorelin. All other procedures will be performed according to the practice of the clinic.&#xD;
&#xD;
      Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg&#xD;
      Triptorelin. All other procedures will be performed according to the practice of the clinic.&#xD;
&#xD;
      Randomization Randomization will be performed using sealed envelopes developed via a computer&#xD;
      generated list with blocks of twelve. The randomization will be performed on day two of the&#xD;
      cycle. Doctors will be blinded to the randomization, but not patients and nurses.&#xD;
&#xD;
      Follicular fluid (FF) collection FF from the first punctured follicle on each side will be&#xD;
      collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.&#xD;
&#xD;
      Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved&#xD;
      and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent&#xD;
      analysis will focus on possible differences in LHR gene expression according to GnRHa trigger&#xD;
      dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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 mature oocytes</measure>
    <time_frame>30 minutes after oocyte retrieval completed</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Day of bleeding after oocyte pick-up</measure>
    <time_frame>in 2 weeks after oocyte pick-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy</measure>
    <time_frame>5 weeks after oocyte pick-up</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Normal Oocyte Donors</condition>
  <arm_group>
    <arm_group_label>0.2mg Triptorelin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.3mg Triptorelin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: 0.4mg Triptorelin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin</intervention_name>
    <description>Triptorelin is given by s.c injection for ovulation triggering.</description>
    <arm_group_label>0.2mg Triptorelin</arm_group_label>
    <arm_group_label>0.3mg Triptorelin</arm_group_label>
    <arm_group_label>Active Comparator: 0.4mg Triptorelin</arm_group_label>
    <other_name>Diphereline 0.1 mg powder and solvent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Oocyte donors who meet the following criteria:&#xD;
&#xD;
          -  Age 18 - 35&#xD;
&#xD;
          -  BMI &lt; 28kg/m2&#xD;
&#xD;
          -  Normal ovarian reserve, defined by AMH &gt; 1.25 ng/ml or AFC ≥ 6 measured within two&#xD;
             months prior to stimulation start&#xD;
&#xD;
          -  Receiving GnRH-antagonist protocol for ovarian stimulation,&#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 without prejudice to future medical care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous poor response (≤ 3 oocytes) after high dose FSH stimulation&#xD;
&#xD;
          -  Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis&#xD;
             B and Sexually Transmitted Diseases Simultaneous participation in an interventional&#xD;
             clinical trial.&#xD;
&#xD;
          -  Concommitant use of either LH or hMG/uFSH preparations in study cycle&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 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>
  <overall_official>
    <last_name>Lan TN Vuong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Humaidan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>My Duc Hospital, IVFMD</name>
      <address>
        <city>Ho Chi Minh City</city>
        <state>Ho Chi Minh</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</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>GnRH antagonist</keyword>
  <keyword>GnRH agonist trigger</keyword>
  <keyword>Oocyte donor</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triptorelin Pamoate</mesh_term>
  </intervention_browse>
  <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/NCT02208986
org study id: NCKH/CGRH_01_2014
nct id: NCT02208986
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this randomized single center study is to explore the most optimal dose of GnRHa
      used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte
      donors who have GnRHa trigger as a standard trigger concept.

      Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa
      will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality
      embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of
      the dose of GnRHa used for trigger.
Methods

      A randomized controlled single center study. All oocyte donors, fulfilling the inclusion
      criteria, will be eligible for inclusion after randomization.

      Stimulation, monitoring, oocyte pick-up in donors and embryo transfer in recipients On day
      two of the cycle, - i.e. prior to commencing stimulation with long acting FSH (Elonva) -
      donors will be randomized to one of three groups, using different doses of GnRHa
      (Triptorelin) for trigger. Stimulation will be performed according to the standard
      stimulation protocol of the clinic, using Elonva followed by co-treatment with a GnRH
      antagonist from day 5 of stimulation . The dose of Elonva used for stimulation will be either
      100 or 150 µg according to the weight of the patient. The first transvaginal ultrasound scan
      (TVUS) will be performed after seven or eight days after the Elonva depot injection. As soon
      as two follicles have reached a size of ≥ 17mm, triggering of final oocyte maturation will be
      performed with one single bolus of Triptorelin, 0.2 mg, 0.3mg or 0.4 mg. The timing of the
      trigger will be 6 AM for all groups and the oocyte pick-up (OPU) will be performed after 34
      hours, according to the usual practice of the clinic. Importantly, each patient will be asked
      to check the presence of an LH surge via a urine LH detection kit at 4 hours after the
      trigger bolus has been administered. Embryo transfer will be performed on day two in all
      recipients.

      Study group I Stimulation according to the abovementioned and ovulation trigger with 0.2mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Study group II Stimulation according to the abovementioned and ovulation trigger with 0.3mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Study group III Stimulation according to the abovementioned and ovulation trigger with 0.4mg
      Triptorelin. All other procedures will be performed according to the practice of the clinic.

      Randomization Randomization will be performed using sealed envelopes developed via a computer
      generated list with blocks of twelve. The randomization will be performed on day two of the
      cycle. Doctors will be blinded to the randomization, but not patients and nurses.

      Follicular fluid (FF) collection FF from the first punctured follicle on each side will be
      collected and cryo-preserved at -20 degrees for subsequent analysis of steroids.

      Granulosa cell gene-expression analysis Cumulus and mural granulosa cells will be preserved
      and snap-frozen from a sub-group of 10 patients in each group. The primary subsequent
      analysis will focus on possible differences in LHR gene expression according to GnRHa trigger
      dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of mature oocytes
time frame: 30 minutes after oocyte retrieval completed
measure: Day of bleeding after oocyte pick-up
time frame: in 2 weeks after oocyte pick-up
measure: Clinical pregnancy
time frame: 5 weeks after oocyte pick-up
arm group label: 0.2mg Triptorelin
arm group type: Active Comparator
description: Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection.
arm group label: 0.3mg Triptorelin
arm group type: Active Comparator
description: Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection.
arm group label: Active Comparator: 0.4mg Triptorelin
arm group type: Active Comparator
description: Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection.
intervention type: Drug
intervention name: Triptorelin
description: Triptorelin is given by s.c injection for ovulation triggering.
arm group label: 0.2mg Triptorelin
arm group label: 0.3mg Triptorelin
arm group label: Active Comparator: 0.4mg Triptorelin
other name: Diphereline 0.1 mg powder and solvent
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Tuong M Ho, MD
role: Principal Investigator
affiliation: CGRH, School of Medicine, Vietnam National University HCMC, Vietnam
last name: Lan TN Vuong, MD
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam
last name: Peter Humaidan, MD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Vietnam National University
investigator full name: Manh Tuong Ho
investigator title: Doctor
mesh term: Triptorelin Pamoate
sharing ipd: No