<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/NCT02210611</url>
  </required_header>
  <id_info>
    <org_study_id>0038-14-EMC</org_study_id>
    <nct_id>NCT02210611</nct_id>
  </id_info>
  <brief_title>36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination</brief_title>
  <official_title>36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved&#xD;
      with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination&#xD;
      than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH&#xD;
      antagonists.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruition too slow&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 29, 2018</completion_date>
  <primary_completion_date type="Actual">April 29, 2018</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 rate</measure>
    <time_frame>4 weeks following insemination</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>36 hours</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intrauterine insemination 36 hours after ovulation induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>42 hours</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intrauterine insemination 42 hours after ovulation induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrauterine Insemination 36 hours</intervention_name>
    <description>Intrauterine insemination 36 hours after ovulation induction</description>
    <arm_group_label>36 hours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrauterine Insemination 42 hours</intervention_name>
    <description>Intrauterine insemination 42 hours after ovulation induction</description>
    <arm_group_label>42 hours</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who can be monitored for follicle growth and hormone measurements on the day&#xD;
             of ovulation trigger, or one day before.&#xD;
&#xD;
          2. Patients who have no more than 4 follicles of 14 mm or more&#xD;
&#xD;
          3. Patients who have no more than 6 follicles of 10 mm or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who cannot give informed consent to language or comprehension barriers&#xD;
&#xD;
          2. Patients who are deemed to be at high risk for high order multiple gestations&#xD;
&#xD;
          3. Patients who cannot be monitored on the day of hCG administration or one day before&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haemek Medical Center, Afula, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emek Medical Center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 25, 2019</last_update_submitted>
  <last_update_submitted_qc>August 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT02210611
org study id: 0038-14-EMC
nct id: NCT02210611
lead sponsor: 
has dmc: No
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved
      with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination
      than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH
      antagonists.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical pregnancy rate
time frame: 4 weeks following insemination
arm group label: 36 hours
arm group type: Active Comparator
description: Intrauterine insemination 36 hours after ovulation induction
arm group label: 42 hours
arm group type: Active Comparator
description: Intrauterine insemination 42 hours after ovulation induction
intervention type: Procedure
intervention name: Intrauterine Insemination 36 hours
description: Intrauterine insemination 36 hours after ovulation induction
arm group label: 36 hours
intervention type: Procedure
intervention name: Intrauterine Insemination 42 hours
description: Intrauterine insemination 42 hours after ovulation induction
arm group label: 42 hours
criteria: 
gender: Female
minimum age: 17 Years
maximum age: 44 Years
healthy volunteers: No
last name: Amir Weiss, MD
role: Principal Investigator
affiliation: Haemek Medical Center, Afula, Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Infertility