<?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>IRCT20190824044599N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-27</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Effect of probiotic administration on male infertility</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effect of probiotic administration on sperm DNA fragmentation, sperm parameters and seminal oxidative stress in men diagnosed with idiopathic infertility</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will recruit permutation block randomization method. Regarding our sample size, 9 blocks containing 8 units (individuals) will be applied. Random sequence will be built on all the possible permutations. Due to our triple blinded design, no allocation concealment will be used, Blinding description: Drug and placebo packings are identical and given to the participants according to randomization sequence. In the present study, health caregivers, researcher(s) in charge of data collection and manuscript drafting, as well as statistical analysis will be blinded.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Idiopathic male infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group of patients receiving a single capsule (500 mg) of FamiLact daily (after meal). Each capsule of FamiLact contains bacterial strains of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus and also 10⁹ CFU of Fructooligosaccharides as prebiotic. FamiLact is a product of Zist Takhmir Pharmaceutical Company, under the permission of Food and Drug department of the Ministry of Health and Medical Education (reference no.: 0347756442342525). Intervention 2: Control group: A group of patients receiving a capsule containing 500 mg of starch per day.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA University of Medical Sciences, Etemadzadeh St., West Fatemi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>bhzd.abbasy@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA University of Medical Sciences, Etemadzadeh St., West Fatemi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 8609 6350</telephone>
        <email>bhzd.abbasy@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile men with abnormal sperm analysis due to unknown underlying cause</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Cryptorchidism
Varicocele
Chromosome abnormalities
Leukocytospermia
Epididymo-orchitis
History of trauma to genitourinary system
Prostatitis
History of testicular torsion
Previous inguinal surgeries
History of Hormonetherapy
History of endocrinopathies
History of medication with cytotoxic drugs, immunosuppressants, androgens, and anticonvulsants
Recent sexually transmitted infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Male infertility, unspecified</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: Group of patients receiving a single capsule (500 mg) of FamiLact daily (after meal). Each capsule of FamiLact contains bacterial strains of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus and also 10⁹ CFU of Fructooligosaccharides as prebiotic. FamiLact is a product of Zist Takhmir Pharmaceutical Company, under the permission of Food and Drug department of the Ministry of Health and Medical Education (reference no.: 0347756442342525).</i_keyword>
      <i_keyword>Control group: A group of patients receiving a capsule containing 500 mg of starch per day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm concentration. Timepoint: Evaluating sperm concentration before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Semen volume. Timepoint: Evaluating semen volume before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Percentage of abnormal sperm morphology. Timepoint: Evaluating the percentage of abnormal sperm morphology before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Percentage of sperm motility. Timepoint: Evaluating the percentage of motile sperm before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Percentage of sperm progressive motility. Timepoint: Evaluating the percentage of sperm progressive motility before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Percentage of sperm lipid peroxidation. Timepoint: Evaluating the percentage of sperm lipid peroxidation before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Intensity of sperm lipid peroxidation. Timepoint: Evaluation the intensity of sperm lipid peroxidation before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
      <prim_outcome>Percentage of sperm DNA damage index. Timepoint: Evaluating the percentage of sperm DNA damage index before and 80 days after probiotic administration. Method of measurement: Semen sample analysis (SCSA test).</prim_outcome>
      <prim_outcome>Percentage of sperm protamine deficiency. Timepoint: Evaluating the percentage of sperm protamine deficiency before and 80 days after probiotic administration. Method of measurement: Semen sample analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-30</approval_date>
        <contact_name>Ethics Committee of AJA University of Medical Sciences</contact_name>
        <contact_address>AJA University of Medical Sciences, Etemadzadeh St., West Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
