<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/NCT03794037</url>
  </required_header>
  <id_info>
    <org_study_id>Hawaa-5</org_study_id>
    <nct_id>NCT03794037</nct_id>
  </id_info>
  <brief_title>Montelukast for Prevention &amp; Treatment of OHSS</brief_title>
  <official_title>Montelukast for Prevention &amp; Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hawaa Fertility Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Benha University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      montelukast &amp; dydrgesteron will be given to cases with suspected or proven ovarian&#xD;
      hyperstimulation in one group in comparison with dydrogesteron alone in the other group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then&#xD;
      montelukast &amp; dydrgesteron will be given to cases with suspected or proven ovarian&#xD;
      hyperstimulation in one group in comparison with dydrogesteron alone in the other group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    no fund&#xD;
  </why_stopped>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants who develop ovarian hyperstimulation syndrome</measure>
    <time_frame>0-14 days</time_frame>
    <description>incidence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants treated of ovarian hyperstimulation syndrome</measure>
    <time_frame>0-14 days</time_frame>
    <description>treatment &amp; resolution</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Ovarian Hyperstimulation Syndrome</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dydrgesterone 10 mg( tab)/12hs/14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dydrgesterone 10 mg( tab)/12hs/14 days</intervention_name>
    <description>Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup</description>
    <arm_group_label>control</arm_group_label>
    <other_name>progesterone only</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days</intervention_name>
    <description>montelukast 10 mg(tab) once daily oral for 7 days &amp; dydrgesterone 10 mg (tab) twice daily oral for 14 days &amp;</description>
    <arm_group_label>study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCOS high responders high numbers of ovum retrieved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensitivity to any drug components phenylketonuria patients depression liver&#xD;
             dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>infertile females undergoing ART cycles</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ahmed sa saad, MD, ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hawaa Fertility Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banha University- Hawaa Fertility center</name>
      <address>
        <city>Banha</city>
        <state>Qalyubiya</state>
        <zip>13512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 18, 2022</last_update_submitted>
  <last_update_submitted_qc>September 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Ahmed Saad</investigator_full_name>
    <investigator_title>Assistant professor of Ob. &amp; Gyn.</investigator_title>
  </responsible_party>
  <keyword>ovarian hyperstimulation syndrome</keyword>
  <keyword>Montelukast</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>Montelukast</mesh_term>
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>study protocol, results,statistics</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
    <ipd_access_criteria>drahmedsaad@live.com</ipd_access_criteria>
  </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/NCT03794037
org study id: Hawaa-5
nct id: NCT03794037
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
montelukast & dydrgesteron will be given to cases with suspected or proven ovarian
      hyperstimulation in one group in comparison with dydrogesteron alone in the other group.
patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then
      montelukast & dydrgesteron will be given to cases with suspected or proven ovarian
      hyperstimulation in one group in comparison with dydrogesteron alone in the other group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of Participants who develop ovarian hyperstimulation syndrome
time frame: 0-14 days
description: incidence
measure: Number of Participants treated of ovarian hyperstimulation syndrome
time frame: 0-14 days
description: treatment & resolution
arm group label: control
arm group type: Active Comparator
description: dydrgesterone 10 mg( tab)/12hs/14 days
arm group label: study
arm group type: Experimental
description: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
intervention type: Drug
intervention name: dydrgesterone 10 mg( tab)/12hs/14 days
description: Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup
arm group label: control
other name: progesterone only
intervention type: Combination Product
intervention name: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
description: montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &
arm group label: study
criteria: 
gender: Female
gender based: Yes
gender description: infertile females undergoing ART cycles
minimum age: 20 Years
maximum age: 37 Years
healthy volunteers: No
last name: ahmed sa saad, MD, ph D
role: Principal Investigator
affiliation: Hawaa Fertility Center
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Ahmed Saad
investigator title: Assistant professor of Ob. & Gyn.
mesh term: Ovarian Hyperstimulation Syndrome
mesh term: Syndrome
mesh term: Montelukast
mesh term: Progesterone
sharing ipd: Yes
ipd description: study protocol, results,statistics
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 6 months
ipd access criteria: drahmedsaad@live.com