<?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>IRCT20170923036334N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-07</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>Modification of Complications in Infertile Men with Varicocele by Curcumin Nanomicels</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Curcumin Nanomicelle on Semen Parameters, Oxidative Stress, and Reproductive Hormones in Varicocele Men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62766</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this Study Simple Individual Randomization Using Software
The Rendering is Done, Blinding description: Urologist by the Project Manager about the Drug Nanocell Curcumin
  He was Fully Informed and Informed about the Properties and Side Effects of the Drug Placement of Patients in the Control and Treatment Group is the Responsibility of the Urologist Be Patients who have Entered the Plan with Full Consent but are Informed of the Appointment There is no Control or Treatment in the Control Group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Varicocele.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:In the Intervention Group of Varicocele Patients Who were Treated with Nano-micelles Curcumin 80 mg Daily for 10 Weeks, Serum and Semen Samples were Taken from them After Taking the Drug. Intervention 2: Control group: In the Control Group of Varicocele Patients who Received Placebo for 10 Weeks, Blood Serum and Semen Samples were Taken After Taking the Drug.</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 Its Release Schedule is not Yet Known."No more information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Verdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713133483</zip>
        <telephone>+98 25 3270 0155</telephone>
        <email>Atefeh.Verdi@yahoo.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahil Jannatifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713133483</zip>
        <telephone>+98 25 3270 0155</telephone>
        <email>rahiljanati2016@gmail.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile Men with Varicocele</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I86.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Scrotal varices</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group:In the Intervention Group of Varicocele Patients Who were Treated with Nano-micelles Curcumin 80 mg Daily for 10 Weeks, Serum and Semen Samples were Taken from them After Taking the Drug.</i_keyword>
      <i_keyword>Control group: In the Control Group of Varicocele Patients who Received Placebo for 10 Weeks, Blood Serum and Semen Samples were Taken After Taking the Drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Levels of Sex Hormones. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: Eliza Kit.</prim_outcome>
      <prim_outcome>Sperm Parameters. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: Standard Clinical Analysis of Semen for Evaluation of Sperm Parameters with The Usual Laboratory Method and Light Microscope According to the Organization CriteriaWHO-2010 World Health Takes Place.</prim_outcome>
      <prim_outcome>Oxidative Stress Rate. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: ROS Positive Sperms were Evaluated Using H2DCFDA (DCFH - DA: 2 ', 7'-dichlorodihydrofluoresceindiacetat) (Sigma Co., USA) and Analyzed by Flow Cytometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Viability. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: Viability is Assessed by Eosin-Nigrosin Staining and Examined Using a Light Microscope.</sec_outcome>
      <sec_outcome>DNA Damage Assessment. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: Tunnel Kit.</sec_outcome>
      <sec_outcome>Measurement of Sperm Mitochondrial Activity. Timepoint: Before Taking the Drug and 10 Weeks After Taking the Drug. Method of measurement: Rhodamine Staining is Used to Assess the Mitochondrial Activity of Sperm.</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>Iranian academic center for education culture and research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-14</approval_date>
        <contact_name>Ethics Committee Mashhad University Jahad</contact_name>
        <contact_address>No 13,Floor 4, Nilofar Unit,Bahar Building,3 th Alley,Naja Street,Loghman Ave Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
