<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/NCT01714648</url>
  </required_header>
  <id_info>
    <org_study_id>MSD-ELISHA1</org_study_id>
    <secondary_id>8328-086</secondary_id>
    <nct_id>NCT01714648</nct_id>
  </id_info>
  <brief_title>Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?</brief_title>
  <official_title>An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elisha Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Elisha Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for&#xD;
      IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using&#xD;
      GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final&#xD;
      oocyte maturation after ovarian stimulation. In high responder patients with potential risk&#xD;
      of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without&#xD;
      obtaining (cryopreserved) embryos for replacement.&#xD;
&#xD;
      An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist&#xD;
      instead of hCG. This method is not possible following a long GnRH agonist protocol which&#xD;
      causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the&#xD;
      GnRH receptor remains receptive to competitive binding by a GnRH agonist.&#xD;
&#xD;
      It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace&#xD;
      the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and&#xD;
      FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the&#xD;
      risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to&#xD;
      the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would&#xD;
      require alternative luteal phase support to secure good clinical outcome. Alternatively, good&#xD;
      quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in&#xD;
      following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS&#xD;
      due to pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated: recruiting or enrolling participants has halted prematurely and will not resume;&#xD;
    participants are no longer being examined or treated&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.</measure>
    <time_frame>12 day from GnRH agonist trigger day.</time_frame>
    <description>OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.</measure>
    <time_frame>One month from embryo transfer date</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Ovarian Hyperstimulation Syndrome</condition>
  <arm_group>
    <arm_group_label>OHSS high risk patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Triptorelin 0.2 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin 0.2 mg</intervention_name>
    <description>A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.</description>
    <arm_group_label>OHSS high risk patients</arm_group_label>
    <other_name>Decapeptyl 0.2 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A female patient who needs IVF to become pregnant.&#xD;
&#xD;
          -  Regular menstrual cycle.&#xD;
&#xD;
          -  Antral follicular count (AFC) &gt; 18&#xD;
&#xD;
          -  Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to the active substance or to any of the medications used.&#xD;
&#xD;
          -  Tumors of the ovary, breast, uterus, pituitary or hypothalamus.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.&#xD;
&#xD;
          -  Primary ovarian failure.&#xD;
&#xD;
          -  Ovarian cysts or enlarged ovaries.&#xD;
&#xD;
          -  A history of Ovarian Hyperstimulation Syndrome (OHSS).&#xD;
&#xD;
          -  A previous COS cycle that resulted in more than 30 follicles &gt; 11 mm measured by&#xD;
             ultrasound examination.&#xD;
&#xD;
          -  Fibroid tumours of the uterus incompatible with pregnancy.&#xD;
&#xD;
          -  Malformations of the reproductive organs incompatible with pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shahar Kol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elisha Hospital, Haifa, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVF Unit, Elisha Hospital</name>
      <address>
        <city>Haifa</city>
        <zip>31064</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>August 3, 2015</last_update_submitted>
  <last_update_submitted_qc>August 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Elisha Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Shahar Kol</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>OVULATION INDUCTION</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Hyperstimulation Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triptorelin Pamoate</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/NCT01714648
org study id: MSD-ELISHA1
secondary id: 8328-086
nct id: NCT01714648
lead sponsor: 
collaborator: 
has dmc: No
Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for
      IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using
      GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final
      oocyte maturation after ovarian stimulation. In high responder patients with potential risk
      of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without
      obtaining (cryopreserved) embryos for replacement.

      An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist
      instead of hCG. This method is not possible following a long GnRH agonist protocol which
      causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the
      GnRH receptor remains receptive to competitive binding by a GnRH agonist.

      It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace
      the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and
      FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the
      risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to
      the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would
      require alternative luteal phase support to secure good clinical outcome. Alternatively, good
      quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in
      following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS
      due to pregnancy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
time frame: 12 day from GnRH agonist trigger day.
description: OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
measure: Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.
time frame: One month from embryo transfer date
arm group label: OHSS high risk patients
arm group type: Experimental
description: Triptorelin 0.2 mg
intervention type: Drug
intervention name: Triptorelin 0.2 mg
description: A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
arm group label: OHSS high risk patients
other name: Decapeptyl 0.2 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Shahar Kol, MD
role: Principal Investigator
affiliation: Elisha Hospital, Haifa, Israel
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Elisha Hospital
investigator full name: Dr. Shahar Kol
investigator title: Principal Investigator
mesh term: Ovarian Hyperstimulation Syndrome
mesh term: Syndrome
mesh term: Triptorelin Pamoate