<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/NCT03804294</url>
  </required_header>
  <id_info>
    <org_study_id>Vitamin D and ART</org_study_id>
    <nct_id>NCT03804294</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);</brief_title>
  <acronym>ART</acronym>
  <official_title>Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the&#xD;
      male and female reproductive system. Animal experiments have shown that vitamin D deficiency&#xD;
      can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related&#xD;
      to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be&#xD;
      related to androgen levels and sperm quality, but whether vitamin D affects the outcome of&#xD;
      assisted reproduction is controversial and inconclusive. This study intends to explore&#xD;
      whether vitamin D affects the outcome of assisted reproduction through a large sample cohort&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin&#xD;
      D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for&#xD;
      vitamin D deﬁciency (&lt;20 ng/mL), insufﬁciency (20-30 ng/mL), and replete (&gt;30 ng/mL).&#xD;
&#xD;
      This is a retrospective cohort study of about 2000 infertile couples who undergo their ﬁrst&#xD;
      IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.&#xD;
      Patients will be excluded if they refuse to be recruited. Serum samples are collected the day&#xD;
      when patients first time to Reproductive Medicine Center and were stored at -20℃ until&#xD;
      assayed. Life style of patients is collected by questionair. Vitamin D status is measured by&#xD;
      assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples&#xD;
      using radioimmunoassay.&#xD;
&#xD;
      The investigators will comapere the ART outcomes in different groups according to serum&#xD;
      25(OH)D status.&#xD;
&#xD;
      In female, the primary outcome is clinical pregnancy rates deﬁned as the presence of an&#xD;
      intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation.&#xD;
      Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.&#xD;
&#xD;
      In male, the primary outcome is semen quality, such as semen volume, sperm concentration,&#xD;
      sperm motility, morphologically normal percent and progressive motile spermatozoa percent.&#xD;
      Secondary outcomes are clinical pregnancy rates and live birth rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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 rates</measure>
    <time_frame>12 weeks after transplantation</time_frame>
    <description>Time Frame:&#xD;
the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>ART</condition>
  <arm_group>
    <arm_group_label>vitamin D-ART</arm_group_label>
    <description>Infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle in Reproductive Medicin Center of Peking university Third Hosiptal.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        infertile couples&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle at Reproductive Medicine&#xD;
        Center of Peking University Third Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        refusing to be recruited.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>XU ZHI</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>XU ZHI, doctor</last_name>
    <phone>01082266757</phone>
    <phone_ext>01082266757</phone_ext>
    <email>zhixujp@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yilu chen, bachelor</last_name>
    <phone>8601082266752</phone>
    <phone_ext>01082266757</phone_ext>
    <email>yilua_chen@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100091</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>XU ZHI</last_name>
      <phone>01082266757</phone>
      <email>zhixujp@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
    <investigator_full_name>Zhi Xu</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03804294
org study id: Vitamin D and ART
nct id: NCT03804294
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vitamin D has many biological functions. Vitamin D receptors are widely distributed in the
      male and female reproductive system. Animal experiments have shown that vitamin D deficiency
      can affect hormone synthesis and gamete formation, reduce sperm motility, and may be related
      to diseases such as PCOS and endometriosis. Population studies suggest that vitamin D may be
      related to androgen levels and sperm quality, but whether vitamin D affects the outcome of
      assisted reproduction is controversial and inconclusive. This study intends to explore
      whether vitamin D affects the outcome of assisted reproduction through a large sample cohort
      study.
Vitamin D plays an important role in reproduction, while there is high prevalence of vitamin
      D deficiency. Serum 25(OH)D was categorized according to clinically accepted ranges for
      vitamin D deﬁciency (<20 ng/mL), insufﬁciency (20-30 ng/mL), and replete (>30 ng/mL).

      This is a retrospective cohort study of about 2000 infertile couples who undergo their ﬁrst
      IVF/ICSI and IUI cycle at Reproductive Medicine Center of Peking University Third Hospital.
      Patients will be excluded if they refuse to be recruited. Serum samples are collected the day
      when patients first time to Reproductive Medicine Center and were stored at -20℃ until
      assayed. Life style of patients is collected by questionair. Vitamin D status is measured by
      assessing circulating levels of 25(OH)D in frozen, never previously thawed serum samples
      using radioimmunoassay.

      The investigators will comapere the ART outcomes in different groups according to serum
      25(OH)D status.

      In female, the primary outcome is clinical pregnancy rates deﬁned as the presence of an
      intrauterinesac with an embryonic pole demonstrating cardiacactivity at 7 weeks of gestation.
      Secondary outcomes are quality of embryo, positive hCG rates and live birth rates.

      In male, the primary outcome is semen quality, such as semen volume, sperm concentration,
      sperm motility, morphologically normal percent and progressive motile spermatozoa percent.
      Secondary outcomes are clinical pregnancy rates and live birth rates.
observational model: Cohort
time perspective: Prospective
measure: clinical pregnancy rates
time frame: 12 weeks after transplantation
description: Time Frame:
the presence of an intrauterinesac with an embryonic pole demonstrating cardiacactivity
arm group label: vitamin D-ART
description: Infertile couples who undergo their ﬁrst IVF/ICSI and IUI cycle in Reproductive Medicin Center of Peking university Third Hosiptal.
serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: XU ZHI
role: Study Chair
affiliation: Peking University Third Hospital
last name: XU ZHI, doctor
phone: 01082266757
phone ext: 01082266757
email: zhixujp@163.com
last name: yilu chen, bachelor
phone: 8601082266752
phone ext: 01082266757
email: yilua_chen@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Third Hospital
investigator full name: Zhi Xu
investigator title: associate professor
sharing ipd: Undecided