<?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>IRCT20170923036334N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect rhFSH drug in infertile men</public_title>
      <acronym></acronym>
      <scientific_title>The effect rhFSH drug on sperm parameters,choromatin status and clinical outcomes of  infertile men candidates for ICSI</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31233</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple individual randomization by use of randlist software is applied, Blinding description: In this study, participants were not aware of the drug dose and efficacy in knowing the use of the drug, which is why they are blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>oligospermia.</hc_freetext>
      <i_freetext>Intervention 1: 1-Control group:In the control group, at least 25 ICSI patients were not treated with rhFSH and sperm analysis was performed based on WHO-2010 criteria and DNA damage and blood serum was taken to measure hormones (T, LH, FSH) ) be done. Intervention 2: 2-Intervention group: At least 25 patients with oligo-spermatozoa who were treated with rhFSH (gel) for a period of 2 or 3 months (twice a week for subcutaneous injection), and serum samples were taken to measure hormones (T, LH, FSH). And the semen is prepared after taking the medication (between 48 and 72 hours from the closest approach) into sterile containers for various tests (sperm analysis, based on WHO-2010 benchmark criteria and DNA damage).</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 Due to the confidentiality of the data, no decision is taken to publish it and no further information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Verdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 unit., Hafez Bilding., khalili Ave., Salarieh street</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716963895</zip>
        <telephone>+98 25 3291 7757</telephone>
        <email>Atefeh.Verdi@Yahoo.Com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefeh Verdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 unit., Hafez Bilding., khalili Ave., Salarieh street</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716963895</zip>
        <telephone>+98 25 3291 7757</telephone>
        <email>Atefeh.Verdi@Yahoo.Com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Oligozospermia infertile men</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Men with varicocele, history of varicoceles surgery, systemic disease or taking medication for systemic disease, chemotherapy or radiotherapy history, anatomical problems in the genitals, including testicular atrophy, treatment with antidepressants, are excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>n00-n99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>بیماریهای سیستم تناسلی XIV</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1-Control group:In the control group, at least 25 ICSI patients were not treated with rhFSH and sperm analysis was performed based on WHO-2010 criteria and DNA damage and blood serum was taken to measure hormones (T, LH, FSH) ) be done.</i_keyword>
      <i_keyword>2-Intervention group: At least 25 patients with oligo-spermatozoa who were treated with rhFSH (gel) for a period of 2 or 3 months (twice a week for subcutaneous injection), and serum samples were taken to measure hormones (T, LH, FSH). And the semen is prepared after taking the medication (between 48 and 72 hours from the closest approach) into sterile containers for various tests (sperm analysis, based on WHO-2010 benchmark criteria and DNA damage).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm parameters. Timepoint: In this study, the evaluation of sperm parameters before and after rhFSH is evaluated and the rate of use of rhFSH is three months. Method of measurement: Clinical analysis of semen standard for sperm parameters with the usual laboratory method and optical microscope according to WHO-2010 WHO criteria.</prim_outcome>
      <prim_outcome>DNA Damage. Timepoint: In this study, the evaluation of DNA damage before and after taking rhFSH is measured and the rate of use of rhFSH is three months. Method of measurement: DNA damage is done using the SDF laboratory kit and optical microscope.</prim_outcome>
      <prim_outcome>The amount of hormone FSH. Timepoint: In this study, the amount of FSH is measured before and after the administration of the drug, and the rate of use of rhFSH is three months. Method of measurement: Measurement of FSH levels is done by ELIZA commercial kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Check fertilization rates. Timepoint: One day after sperm injection into the oocyte cytoplasme . Method of measurement: Fertilization can be seen with an inverted microscope.</sec_outcome>
      <sec_outcome>Quality of the embryo. Timepoint: Three days after sperm injection into oocyte cytoplasm. Method of measurement: Evaluating the quality of the embryo is based on the number of cells and the number of blastomers and the fragmentation of the blastomers and is observed with the Invert microscope.</sec_outcome>
      <sec_outcome>Pregnancy. Timepoint: 14 days after the transfer of the embryo into the uterus. Method of measurement: Pregnancy testing is done by giving beta-HCG.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-13</approval_date>
        <contact_name>Ethics Committee Islamic Azad University Medical Sciences</contact_name>
        <contact_address>5 unit., Hafez Bilding., khalili Ave., Salarieh street Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
