<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/NCT03832699</url>
  </required_header>
  <id_info>
    <org_study_id>0013-19-WOMC</org_study_id>
    <nct_id>NCT03832699</nct_id>
  </id_info>
  <brief_title>Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer</brief_title>
  <official_title>Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current trial is intended to assess the efficacy of oral versus vaginal progesterone for&#xD;
      luteal support in frozen IVF cycles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered&#xD;
      vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven&#xD;
      effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF.&#xD;
      Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone&#xD;
      in frozen IVF cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Live birth rate</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Birth of a live infant after 24 weeks gestation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Outcome assesed 6-7 weeks following treatment</time_frame>
    <description>Viable pregnancy as demonstrated by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>Outcome assessed 6-7 weeks following treatment</time_frame>
    <description>Number of gestational sacs divided by number of embryos transferred (percentage)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>ART</condition>
  <arm_group>
    <arm_group_label>Oral progesterone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal progesterone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dydrogesterone 10 MG</intervention_name>
    <description>Oral progesterone 10 mg TID</description>
    <arm_group_label>Oral progesterone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endometrin 100Mg Vaginal Insert</intervention_name>
    <description>Vaginal Endometrin 100 mg twice daily</description>
    <arm_group_label>Vaginal progesterone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-39&#xD;
&#xD;
          -  Modified natural cycle (induction of ovulation with HCG)&#xD;
&#xD;
          -  Consent to participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hadas Ganer Herman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edith Wolfson Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hadas Ganer Herman, MD</last_name>
    <phone>972526206696</phone>
    <email>hadassganer@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hadas Ganer Herman, MD</last_name>
      <phone>9720526206696</phone>
      <email>hadassganer@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Hadas Ganer Herman</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dydrogesterone</mesh_term>
    <mesh_term>Progesterone</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/NCT03832699
org study id: 0013-19-WOMC
nct id: NCT03832699
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The current trial is intended to assess the efficacy of oral versus vaginal progesterone for
      luteal support in frozen IVF cycles.
Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered
      vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven
      effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF.
      Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone
      in frozen IVF cycles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Live birth rate
time frame: Up to 9 months
description: Birth of a live infant after 24 weeks gestation
measure: Clinical pregnancy rate
time frame: Outcome assesed 6-7 weeks following treatment
description: Viable pregnancy as demonstrated by ultrasound
measure: Implantation rate
time frame: Outcome assessed 6-7 weeks following treatment
description: Number of gestational sacs divided by number of embryos transferred (percentage)
arm group label: Oral progesterone
arm group type: Experimental
arm group label: Vaginal progesterone
arm group type: Active Comparator
intervention type: Drug
intervention name: Dydrogesterone 10 MG
description: Oral progesterone 10 mg TID
arm group label: Oral progesterone
intervention type: Drug
intervention name: Endometrin 100Mg Vaginal Insert
description: Vaginal Endometrin 100 mg twice daily
arm group label: Vaginal progesterone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hadas Ganer Herman, MD
role: Principal Investigator
affiliation: Edith Wolfson Medical Center
last name: Hadas Ganer Herman, MD
phone: 972526206696
email: hadassganer@yahoo.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Hadas Ganer Herman
investigator title: Principal investigator
mesh term: Dydrogesterone
mesh term: Progesterone