<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20120913010826N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-29</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of vitamin D supplementation in people with sperm motility disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effect of vitamin D supplementation on androgen hormones, sperm motility, and morphology in patients with sperm motility disorder and vitamin D deficiency.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11257</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the randomized code obtained from the SPSS, Blinding description: Prescribing supplement and placebo by a researcher without knowledge of its type, as well as taking it by the participants in the study without their 
knowledge. In order to minimize bias in the intervention, one researcher randomly assigns random access to the patient in a randomized manner, without any knowledge of the patient's condition, and the other investigator who is associated with the patient, will place that person in the designated group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>asthenozoospermia.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, a dose of 50,000 units of vitamin D was administered for 12 weeks (one perl of vitamin D per week for 8 weeks and only one perl of vitamin d administered as a maintenance dose in the last 4 weeks). Intervention 2: In the control group, placebo was administered for 12 weeks (one placebo per week for 8 weeks and only one placebo administered in the last 4 weeks).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is decision will be made Depending on the case and the request of other researchers,</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Gheflati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>آدرس خیابان Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>alireza.2130@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Najarzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safaeieh, shohadaye gomnam Blvd, Shahid Sadoughi University of Medical Sciences</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 3820 9100</telephone>
        <email>azadehnajarzadeh@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study - men aged 20-45 years old - Passing for at least one year from the time that decide to have a baby and not use contraceptives - sperm motility disorder according to WHO criteria - Not using vitamin D supplements and calcium in the last 3 months- levels of 25 hydroxyvitamin D (25OHD) less than 30 ng / ml</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>unwillingness to participate - Having varicocele - individuals with azoospermia, cryptorchidism, and microorchidism - History of vasectomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Male infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, a dose of 50,000 units of vitamin D was administered for 12 weeks (one perl of vitamin D per week for 8 weeks and only one perl of vitamin d administered as a maintenance dose in the last 4 weeks)</i_keyword>
      <i_keyword>In the control group, placebo was administered for 12 weeks (one placebo per week for 8 weeks and only one placebo administered in the last 4 weeks)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm motility. Timepoint: Before and after intervention. Method of measurement: Semen sample.</prim_outcome>
      <prim_outcome>Total testosterone. Timepoint: Before and after intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Sex hormone binding globulin. Timepoint: Before and after intervention. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Free androgen index. Timepoint: Before and after intervention. Method of measurement: Total testosterone / SHBG.</prim_outcome>
      <prim_outcome>Sperm morphology. Timepoint: Before and after intervention. Method of measurement: Semen sample.</prim_outcome>
      <prim_outcome>Sperm concentration. Timepoint: Before and after intervention. Method of measurement: Semen sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Fat percent. Timepoint: Before and after intervention. Method of measurement: by body composition analyzer.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before and after intervention. Method of measurement: by body composition analyzer.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before and after intervention. Method of measurement: kg/m2.</sec_outcome>
      <sec_outcome>Muscle mass percent. Timepoint: Before and after intervention. Method of measurement: by body composition analyzer.</sec_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before and after intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before and after intervention. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Vitamin D. Timepoint: Before and after intervention. Method of measurement: blood sample.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-06</approval_date>
        <contact_name>Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
