<?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>IRCT2015020120895N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-12</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Antioxidant role of palm pollen in infertility</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Antioxidant Role of Palm Pollen in Oligospermic and Asthenozoospermic Men and Its Correlation with Count, Motility and Morphology of the Sperm</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Participants entered the study after signing a personal and written consent form based on inclusion criteria. Their cement sample was measured before and after treatment with palm pollen capsule for two months in the case group and also the sample of the control group was measured according to the WHO 2010 analysis analysis guidelines. Also, the concentration of 8-Isoprostane, antioxidant genes was examined, Randomization description: Simple randomization with sealed envelope, Blinding description: This study is a randomized, single-blind and comparative clinical trial including 60 cases of male infertility that was conducted during the year March to June 17, 2016. Palm pollen powder at a rate of 400 mg / kg in gelatin capsules was used for two consecutive months to treat eligible individuals.Have been received. The coding is done by one of the project partners and they are blind evaluators.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Male infertility.</hc_freetext>
      <i_freetext>In addition to standard treatment by a urologist, the case group received 400 mg / kg of palm pollen powder in gelatin capsules for two 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Abstract and original article after publication

When:
two months

To whom:
researchers

Conditions:
To conduct scientific research

Where to obtain:
To the clinical trial site

How to obtain:
Email - Call - SMS

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Soghra Fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>fallahi.leila@gmail.com</email>
        <affiliation>fertility and infertility Research Center of Shahid Mohammadi Hospital, Bandar Abbas, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Soghra Fallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamarbandi St., Islamic Republic Boulevard, Shahid Mohammadi Hospital, fertility and Infertility Research Center, Bandar Abbas, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7915915517</zip>
        <telephone>+98 76 3333 7192</telephone>
        <email>fallahi.leila@gmail.com</email>
        <affiliation>fertility and infertility Research Center  Shahid Mohammadi Hospital,Bandar Abbas</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Normal anatomy of the genital area; Infertility due to oligo asthenospermia</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>42 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The case with the following criteria were excluded from the study: history of genetic and systemic disorders, reproductive tract abnormality, testicular trauma, alcohol and substance abuse, and fertility medications at least for six months before participation.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Azoospermia NOS     Oligospermia NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In addition to standard treatment by a urologist, the case group received 400 mg / kg of palm pollen powder in gelatin capsules for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of count, motility and morphology of sperm. Timepoint: 2 months. Method of measurement: Semen analysis.</prim_outcome>
      <prim_outcome>Evaluation of expression of antioxidant SOD, CAT, GPX, NRF2 and KEAP1 genes. Timepoint: 2 months. Method of measurement: RT-PCR.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Semen samples were obtained twice from the case group, before and after treatment, and once from the control group through masturbation, masturbation and abstinence for three to five days. We then collected fresh semen samples in sterile plastic containers. Timepoint: 2 months  after consumption of palm pollen. Method of measurement: The samples were exposed to 37 ° C for 30 minutes for liquefaction and semen analysis (fluid volume, pH, viscosity, sperm morphology, concentration and motility) was performed immediately according to the WHO guideline. Sex hormones were also examined using ELISA. In addition, in this clinical trial, a blind and comparative semen analysis was performed by a technician blindly.</sec_outcome>
      <sec_outcome>Measurement of antioxidant genes and 8- isoprene index. Timepoint: After two months, receive palm pollen. Method of measurement: BSA-free Ham’s-F10  was used twice to wash the samples and then stored in RNALater solution (Qiagen: Germany) at -80 ° C until RNA extraction. Then, after extraction and PCR test, real-time test was performed on the samples.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-23</approval_date>
        <contact_name>Ethics Committee of Molecular Medical Research Center of Bandar Abbas University of Medical Sciences</contact_name>
        <contact_address>Kamarbandi St., Jomhuri Eslami Boulevard,Shahid Mohammadi Hospital,Molecular Medicine Laboratory, Bandar Abbas, Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
