<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/NCT02187146</url>
  </required_header>
  <id_info>
    <org_study_id>RG_13-100</org_study_id>
    <nct_id>NCT02187146</nct_id>
  </id_info>
  <brief_title>The Effects of Serum Vitamin D and IVF Outcome</brief_title>
  <acronym>VIDIO</acronym>
  <official_title>The Effects of Serum Vitamin D and IVF Outcome: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether an association exists between serum&#xD;
      vitamin D levels and IVF treatment outcome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>7 weeks after embryo transfer</time_frame>
    <description>USS appearances of intrauterine pregnancy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical pregnancy rate</measure>
    <time_frame>2 weeks after embryo transfer</time_frame>
    <description>Urinary pregnancy test result 2 weeks after embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>20 weeks after embryo transfer</time_frame>
    <description>Pregnancy outcome of miscarriage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>42 weeks after embryo transfer</time_frame>
    <description>Live birth outcome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">504</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Vitamin D Insufficiency</condition>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>ART population</arm_group_label>
    <description>Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens&#xD;
        Fertility Centre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility&#xD;
             Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Birmingham Womens NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>October 24, 2016</last_update_submitted>
  <last_update_submitted_qc>October 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Birmingham</investigator_affiliation>
    <investigator_full_name>Justin Chu</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Vitamin D</keyword>
  <keyword>Infertility</keyword>
  <keyword>IVF</keyword>
  <keyword>ART</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Vitamin D Deficiency</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/NCT02187146
org study id: RG_13-100
nct id: NCT02187146
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate whether an association exists between serum
      vitamin D levels and IVF treatment outcome
observational model: Cohort
time perspective: Prospective
measure: Clinical Pregnancy Rate
time frame: 7 weeks after embryo transfer
description: USS appearances of intrauterine pregnancy
measure: Biochemical pregnancy rate
time frame: 2 weeks after embryo transfer
description: Urinary pregnancy test result 2 weeks after embryo transfer
measure: Miscarriage rate
time frame: 20 weeks after embryo transfer
description: Pregnancy outcome of miscarriage
measure: Live birth rate
time frame: 42 weeks after embryo transfer
description: Live birth outcome
arm group label: ART population
description: Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 23 Years
maximum age: 43 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Birmingham
investigator full name: Justin Chu
investigator title: Research Fellow
mesh term: Infertility
mesh term: Vitamin D Deficiency