<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/NCT03305510</url>
  </required_header>
  <id_info>
    <org_study_id>Reproductive center of Tongji</org_study_id>
    <nct_id>NCT03305510</nct_id>
  </id_info>
  <brief_title>Vitamin D Deficiency of Couples and Infertility</brief_title>
  <official_title>Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Between March 2016 and March 2017, we performed a large retrospective, non-interventional,&#xD;
      single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation&#xD;
      in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and&#xD;
      reproductive capacity .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before conducting ovarian stimulation, all couples must conduct preoperative routine&#xD;
      examination such as routine blood test, blood group examination and infectious disease&#xD;
      examination. We collected 2ml remaining blood from the examination by use of sodium heparin,&#xD;
      which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.&#xD;
&#xD;
      All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and&#xD;
      fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization&#xD;
      rate was defined as the presence of two pronuclei (2PN) at the time of fertilization&#xD;
      assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality&#xD;
      embryos was defined as the percentage of top quality embryos among the total number of 2PN&#xD;
      embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by&#xD;
      number of cultured blastocysts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fertilization rate</measure>
    <time_frame>the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination</time_frame>
    <description>Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <condition>Infertility</condition>
  <condition>Couples</condition>
  <condition>In-vitro Fertilization</condition>
  <arm_group>
    <arm_group_label>Vitamin D deficiency</arm_group_label>
    <description>The level of vitamin D is below 20ng/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D insufficient</arm_group_label>
    <description>The level of vitamin D is between 20ng/ml and 30ng/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin D sufficient</arm_group_label>
    <description>The level of vitamin D is above 30ng/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>vitamin D is below 20ng/ml</intervention_name>
    <arm_group_label>Vitamin D deficiency</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to&#xD;
        ovarian stimulation in couples who underwent IVF/ICSI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  couples who underwent IVF/ICSI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for&#xD;
             fertilization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kun Qian, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 8, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Liu Jiang</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 3, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>March 29, 2018</submitted>
    <returned>October 18, 2018</returned>
    <submitted>April 10, 2019</submitted>
    <returned>July 11, 2019</returned>
  </pending_results>
  <!-- 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/NCT03305510
org study id: Reproductive center of Tongji
nct id: NCT03305510
lead sponsor: 
has dmc: Yes
Between March 2016 and March 2017, we performed a large retrospective, non-interventional,
      single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation
      in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and
      reproductive capacity .
Before conducting ovarian stimulation, all couples must conduct preoperative routine
      examination such as routine blood test, blood group examination and infectious disease
      examination. We collected 2ml remaining blood from the examination by use of sodium heparin,
      which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.

      All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and
      fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization
      rate was defined as the presence of two pronuclei (2PN) at the time of fertilization
      assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality
      embryos was defined as the percentage of top quality embryos among the total number of 2PN
      embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by
      number of cultured blastocysts.
observational model: Cohort
time perspective: Retrospective
measure: fertilization rate
time frame: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination
description: Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.
arm group label: Vitamin D deficiency
description: The level of vitamin D is below 20ng/ml.
arm group label: Vitamin D insufficient
description: The level of vitamin D is between 20ng/ml and 30ng/ml.
arm group label: Vitamin D sufficient
description: The level of vitamin D is above 30ng/ml.
intervention type: Diagnostic Test
intervention name: vitamin D is below 20ng/ml
arm group label: Vitamin D deficiency
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 42 Years
healthy volunteers: No
last name: Kun Qian, Doctor
role: Study Chair
affiliation: Tongji Hospital
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Liu Jiang
investigator title: MD
mesh term: Infertility
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
sharing ipd: Undecided
submitted: November 3, 2017
submission canceled: Unknown
submitted: March 29, 2018
returned: October 18, 2018
submitted: April 10, 2019
returned: July 11, 2019