<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/NCT01675843</url>
  </required_header>
  <id_info>
    <org_study_id>AG/4/2010</org_study_id>
    <nct_id>NCT01675843</nct_id>
  </id_info>
  <brief_title>Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome</brief_title>
  <acronym>OSIPS</acronym>
  <official_title>Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy&#xD;
      rates in women with polycystic ovary syndrome. Infertile women with pcos will receive&#xD;
      gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse&#xD;
      (TI)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live Birth Rate</measure>
    <time_frame>20 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>multiple pregnancy rate</measure>
    <time_frame>20 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Infertility</condition>
  <condition>Polycystic Ovarian Syndrome</condition>
  <condition>Intrauterine Insemination</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrauterine insemination (IUI)</intervention_name>
    <description>The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>IUI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - women who failed to get pregnant after 6 ovulation induction cycles with clomiphene&#xD;
        citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as&#xD;
        confirmed by hysterosalpingography and their partners had fertile semen parameters&#xD;
        according to criteria of World Health Organization (WHO 2010)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        male factor infertility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Gibreel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Care Unit</name>
      <address>
        <city>Mansoura</city>
        <state>Eldakahlia</state>
        <zip>53111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ahmed Gibreel</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>PCOS</keyword>
  <keyword>IUI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Syndrome</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/NCT01675843
org study id: AG/4/2010
nct id: NCT01675843
lead sponsor: 
has dmc: Yes
The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy
      rates in women with polycystic ovary syndrome. Infertile women with pcos will receive
      gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse
      (TI)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Live Birth Rate
time frame: 20 months
measure: Clinical pregnancy rate
time frame: 16 months
measure: multiple pregnancy rate
time frame: 20 months
arm group label: Group A
arm group type: Experimental
description: controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)
arm group label: Group B
arm group type: No Intervention
description: Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)
intervention type: Procedure
intervention name: Intrauterine insemination (IUI)
description: The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
arm group label: Group A
other name: IUI
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 38 Years
healthy volunteers: No
last name: Ahmed Gibreel, MD
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ahmed Gibreel
investigator title: Dr
mesh term: Polycystic Ovary Syndrome
mesh term: Infertility
mesh term: Syndrome