<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/NCT02987478</url>
  </required_header>
  <id_info>
    <org_study_id>6789</org_study_id>
    <nct_id>NCT02987478</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection</brief_title>
  <official_title>Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <brief_summary>
    <textblock>
      All patients will undergo in vitro fertilization.&#xD;
&#xD;
      Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.&#xD;
&#xD;
      Whole blood specimens will be collected in serum separator tubes using acceptable medical&#xD;
      techniques to avoid hemolysis.&#xD;
&#xD;
      Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.&#xD;
&#xD;
      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound&#xD;
      performed 4-5 weeks after embryo transfer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PATIENTS AND METHODS&#xD;
&#xD;
      Protocol Outline:&#xD;
&#xD;
      The Study:&#xD;
&#xD;
      Study site:&#xD;
&#xD;
      Ain Shams University Maternity Hospital.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      A prospective Cohort study.&#xD;
&#xD;
      Study setting:&#xD;
&#xD;
      The study will be conducted at Ain Shams University Maternity Hospital.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The study will include all women planned to undergo IVF due to unexplained infertility.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The study will be approved by the hospital ethics committee.&#xD;
&#xD;
      All included women will undergo the following:&#xD;
&#xD;
        -  History taking.&#xD;
&#xD;
        -  General and abdominal examination.&#xD;
&#xD;
        -  Vaginal examination and assessment&#xD;
&#xD;
        -  Pelvic ultrasound.&#xD;
&#xD;
        -  Routine laboratory investigations including complete blood picture, hematocrit, liver&#xD;
           and kidney function tests and coagulation profile.&#xD;
&#xD;
        -  Preoperative senior anesthetist assessment.&#xD;
&#xD;
        -  Hysteroscopy.&#xD;
&#xD;
      All patients will undergo IVF.&#xD;
&#xD;
      Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.&#xD;
&#xD;
      Whole blood specimens will be collected in serum separator tubes using acceptable medical&#xD;
      techniques to avoid hemolysis.&#xD;
&#xD;
      Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.&#xD;
&#xD;
      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound&#xD;
      performed 4-5 weeks after embryo transfer.&#xD;
&#xD;
      Measurement of Outcomes&#xD;
&#xD;
        1. serum 25 (OH) D levels.&#xD;
&#xD;
        2. Number of oocyte.&#xD;
&#xD;
           Most studies put the optimal number of retrieved oocytes between 10 and 15.&#xD;
&#xD;
        3. The implantation rate:&#xD;
&#xD;
           Calculated as the number of gestational sacs observed by ultrasound divided by the&#xD;
           number of embryos transferred, multiplied by 100.&#xD;
&#xD;
        4. Number of gestational sac.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">March 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy</measure>
    <time_frame>4-5 weeks</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Infertility</condition>
  <eligibility>
    <study_pop>
      <textblock>
        -  Age between 20 and 35 years old.&#xD;
&#xD;
          -  Body mass index between 20 - 30.&#xD;
&#xD;
          -  Unexplained infertility .&#xD;
&#xD;
          -  Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).&#xD;
&#xD;
          -  Normal hysteroscopy .&#xD;
&#xD;
          -  Fresh embryo transfer of 2 or more blastocysts stage.&#xD;
&#xD;
          -  Embryo transfer on day 5 after fertilization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20 and 35 years old.&#xD;
&#xD;
          -  Body mass index between 20 - 30.&#xD;
&#xD;
          -  Unexplained infertility .&#xD;
&#xD;
          -  Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).&#xD;
&#xD;
          -  Normal hysteroscopy ( healthy uterus with no fibroids or other growths)&#xD;
&#xD;
          -  Fresh embryo transfer of 2 or more blastocysts stage.&#xD;
&#xD;
          -  Embryo transfer on day 5 after fertilization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women younger than 20 years old or older than 35 years old.&#xD;
&#xD;
          -  Previous one or more failed IVF.&#xD;
&#xD;
          -  Uncorrected congenital or acquired uterine anomalies.&#xD;
&#xD;
          -  Other causes of infertility rather than unexplained infertility.&#xD;
&#xD;
          -  Less than 2 embryo transfer, cleavage stager frozen embryo transfer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammed Samy, MD</last_name>
    <phone>+20100 194 7488</phone>
    <email>dr_hend_kamal@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassia</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moh Samy, MD</last_name>
      <phone>201002554281</phone>
      <email>dr_hend_kamal@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Mohammed Samy, MD</last_name>
      <phone>+20100 194 7488</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Alaa Sayed Abdul-hafeez</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Vitamin D following intra cytoplasmic sperm injection</keyword>
  <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/NCT02987478
org study id: 6789
nct id: NCT02987478
lead sponsor: 
All patients will undergo in vitro fertilization.

      Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.

      Whole blood specimens will be collected in serum separator tubes using acceptable medical
      techniques to avoid hemolysis.

      Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.

      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound
      performed 4-5 weeks after embryo transfer.
PATIENTS AND METHODS

      Protocol Outline:

      The Study:

      Study site:

      Ain Shams University Maternity Hospital.

      Study Design:

      A prospective Cohort study.

      Study setting:

      The study will be conducted at Ain Shams University Maternity Hospital.

      Study population:

      The study will include all women planned to undergo IVF due to unexplained infertility.

      Methodology:

      The study will be approved by the hospital ethics committee.

      All included women will undergo the following:

        -  History taking.

        -  General and abdominal examination.

        -  Vaginal examination and assessment

        -  Pelvic ultrasound.

        -  Routine laboratory investigations including complete blood picture, hematocrit, liver
           and kidney function tests and coagulation profile.

        -  Preoperative senior anesthetist assessment.

        -  Hysteroscopy.

      All patients will undergo IVF.

      Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.

      Whole blood specimens will be collected in serum separator tubes using acceptable medical
      techniques to avoid hemolysis.

      Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.

      clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound
      performed 4-5 weeks after embryo transfer.

      Measurement of Outcomes

        1. serum 25 (OH) D levels.

        2. Number of oocyte.

           Most studies put the optimal number of retrieved oocytes between 10 and 15.

        3. The implantation rate:

           Calculated as the number of gestational sacs observed by ultrasound divided by the
           number of embryos transferred, multiplied by 100.

        4. Number of gestational sac.
observational model: Cohort
time perspective: Prospective
measure: pregnancy
time frame: 4-5 weeks
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohammed Samy, MD
phone: +20100 194 7488
email: dr_hend_kamal@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Alaa Sayed Abdul-hafeez
investigator title: Clinical Professor
mesh term: Infertility