<?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>IRCT20171209037794N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-10</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ceratonia siliqua on male infertility.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of Ceratonia siliqua fruit syrup and vitamin E on sperm parameters, oxidative stress index and sex hormones in infertile men.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29376</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization will be used to achieve balance in the allocation of participants to intervention arms. Before initiation of the run- in phase of the study, two 40- sets of random numbers will be created by a member of the research team not involved in recruitment. 15 blocks with size of 4 and combination of A for the carob and B for vitamin E group will be prepared. Allocation sequence will be password-protected and only accessible to the reproductive health researcher. She folds  the paper containing 4-size blocks, put them in the standard thick envelopes and write the serial numbers on them. All of the envelope will be kept at the recruitment center. Thus, for every eligible patient, the researcher randomly selects one of the envelopes after  assign subjects into intervention and comparison group, Blinding description: outcome assessor and data analyser will be blinded to group assignment for the exploratory outcomes of treatment, treatment completion and treatment response which will be assessed by medical staff not otherwise involved in the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Male infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ceratonia siliqua syrup twice a day for three months. Intervention 2: Control group: 100 mg capsule of vitamin E once a day for three months.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Parvaneh Mirabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۵۴</zip>
        <telephone>+98 11 3219 0558</telephone>
        <email>parvaneh.mirabi@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Parvaneh Mirabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۵۴</zip>
        <telephone>+98 11 3219 0557</telephone>
        <email>parvaneh.mirabi@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20 - 45 years of age, who had complained of infertility for at least 12 months, and had no history of surgical or medical treatments for infertility
Unspecified oligospermia based on WHO criteria (sperm count less than 20 million per ml, type A motility less than 25%, and type B motility less than 50%; normal morphology less than 15%);
Having a BMI less than 30
Not smoking, drinking alcohol, and addiction to substance
Normal level of gonadotropins, testosterone and Prolactin
Lack of systemic diseases, such as diabetes and thyroid, cerebrovascular disease and had no history of chemotherapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>A history of vasectomy or obstructive azoospermia
Azospermia  and chromosomal abnormalities such as kleinfelter's Syndrome
Hypogonadism or pituitary abnormalities
The use of antioxidant supplements in the last three months
Taking medications that stimulate the sexual system or disrupt the sex hormones
Having severe physical activity
Genital tract infection, recurrent or residual varicocoele and history of cryptorchidism
Infectious diseases characterized by fever and leukocytosis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oligospermia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ceratonia siliqua syrup twice a day for three months</i_keyword>
      <i_keyword>Control group: 100 mg capsule of vitamin E once a day for three months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm count. Timepoint: Before and three months after intervention. Method of measurement: Semen analysis.</prim_outcome>
      <prim_outcome>Sperm morphology. Timepoint: Before intervention and three months after intervention. Method of measurement: Semen analysis.</prim_outcome>
      <prim_outcome>Sperm motility. Timepoint: Before and three months after intervention. Method of measurement: Semen analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum concentrations of Malondialdehyde. Timepoint: Before and three months after intervention. Method of measurement: TBARS method using Spectrophotometer.</sec_outcome>
      <sec_outcome>Sex hormones. Timepoint: Before and three months after intervention. Method of measurement: Eliza.</sec_outcome>
      <sec_outcome>Superoxide dismutase enzyme. Timepoint: Before and three months after intervention. Method of measurement: Calorimetric.</sec_outcome>
      <sec_outcome>Zinc. Timepoint: Before and three months after intervention. Method of measurement: Atomic Absorption Spectrophotometry.</sec_outcome>
      <sec_outcome>Selenium. Timepoint: Before and three months after intervention. Method of measurement: Atomic Absorption Spectrophotometry.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Babol University of Medical Sciences</sponsor_name>
      <sponsor_name>Babol University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Babol University of Medical Sciences</source_name>
      <source_name>Babol University of Medical Sciences</source_name>
      <source_name>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-24</approval_date>
        <contact_name>Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Mazandaran, Babol, Ganj Afrooz Avenue, Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
