<?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>IRCT20200929048878N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-18</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>Comparison of the effect of combined herbal medicine with routine medicine on sperm quality and chromatine integrity in oligoasthenoteratozoospermia men</public_title>
      <acronym></acronym>
      <scientific_title>The study of the effect of combination herbal therapy (zayesh booalidaroo®+ Safoof hefz + Royal gel) on sperm quality and chromatine integrity in oligoasthenoteratozoospermia men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51284</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The way to select groups is that they will be assigned to groups based on block randomization. Blocks of size 4 are considered. So we will have six blocks containing AABB, ABAB, BBAA, BABA, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if thrown dice is 3, the BBAA block is considered, and therefore the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown 20 times to complete the assignment of patients to the treatment groups. randomization is performed using the DOE option in MINITAB ver 15 software.</study_design>
      <phase>3</phase>
      <hc_freetext>Oligoasthenotratosospermia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group of Zayesh Majoon(Twice a day, 8 grams each time), Royal Jelly capsule and Safof hefz capsule (made by BooaliDaroo company) Twice a day for a 90-day period. Intervention 2: Control group: Sprigen oral supplement (contains vitamins C, E, D3, B1, B2, B6, B12, A, folic acid, Zinc, niacin, biotin, magnesium, L-carnitine, coenzyme Q10, inositol and N-acetylcysteine) and tamoxifen (2 tablets in the morning and evening) over a period of 90 days.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Naserpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom, Shahid Karimi Blvd., Isar Town, Isar Square, Shabnam St.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716986466</zip>
        <telephone>+98 25 3270 0155</telephone>
        <email>Leilanasery48@gmail.com</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Naserpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qom, Shahid Karimi Blvd., Isar Town, Isar Square, Shabnam St.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716986466</zip>
        <telephone>+98 25 3270 0155</telephone>
        <email>Leilanasery48@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>Patients with oligo asthenotratospermia(Total sperm count is 15 or less than 15 million per milliliter.The percentage of normal morphology or appearance is less than 4.Sperm motility is less than 40%.
The patient's spouse is fertile.
Have a history of infertility for at least one year.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of receiving chemotherapy drugs, corticosteroids, anticoagulants, testosterone, anti-androgens two months before the start of the study
Genital infections, anatomical abnormalities, chromosomal abnormalities, history of genital surgery (varicocele, ...)
Alcohol or drug use
Patients with Ejaculation disorder
Systemic diseases (malignancy, thyroid disease, liver and gallbladder)
Cr&gt;1.5
Sgot&gt;80
Sgpt&gt;80
Hb&lt;10</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group of Zayesh Majoon(Twice a day, 8 grams each time), Royal Jelly capsule and Safof hefz capsule (made by BooaliDaroo company) Twice a day for a 90-day period</i_keyword>
      <i_keyword>Control group: Sprigen oral supplement (contains vitamins C, E, D3, B1, B2, B6, B12, A, folic acid, Zinc, niacin, biotin, magnesium, L-carnitine, coenzyme Q10, inositol and N-acetylcysteine) and tamoxifen (2 tablets in the morning and evening) over a period of 90 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm count. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: optical microscope.</prim_outcome>
      <prim_outcome>Sperm motility. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: optical microscope.</prim_outcome>
      <prim_outcome>Sperm morphology. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: staining.</prim_outcome>
      <prim_outcome>Sperm DNA fragmentation. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: optical microscope.</prim_outcome>
      <prim_outcome>Protamine deficiency. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Fluorescent microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Follicle-stimulating hormone,Luteinizing Hormone,Testosterone. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: kit.</sec_outcome>
      <sec_outcome>Malondialdehyde. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: ELISA Kit.</sec_outcome>
      <sec_outcome>Total antioxidant capacity. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: ELISA Kit.</sec_outcome>
      <sec_outcome>Erectile quality. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: International Index of Erectile Function Questionnaire (IIEF).</sec_outcome>
      <sec_outcome>Quality of sexual life. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Sexual Quality of Life Questionnaire (SQOL).</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>BooaliDaroo pharmaceutical company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-26</approval_date>
        <contact_name>Organizational Committee of Ethics in Biomedical Research</contact_name>
        <contact_address>15 Khordad Blvd., Islamic Azad University, Qom Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
