<?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>IRCT201604304076N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-27</date_registration>
      <primary_sponsor>Resaerch Deputy of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Response to Treatment of HIV-1 Infected Men's Semen Sperm Washing Method in Pregnancy of Sero-Discordant Couples</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Response to Treatment of HIV-1 Infected Men's Semen Sperm Washing Method in Pregnancy of Sero-Discordant Couples who Referred to Behavioral Diseases Consultation Center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4263</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: HIV/AIDS. Condition 2: Pregnancy, childbirth and the puerperium.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this method, healthy and motile uninfected sperm cells are isolated from other cells. Semen samples will be loaded on a sperm washing medium gradient and then centrifuged. Finally healthy and motile uninfected sperm cells will deposit. For the next step, sperm pellet will be load on the bottom of a sterile tube which is filled with Ham's F10 and will be incubate for 30 minutes in 37 C temperature. Healthy and motile sperm cells will swim to the upper surface of medium, and concentrate there and will be isolated for next step. For evaluating of the effectiveness of the sperm washing, viral load counting (Real Time PCR) will be done on a part of the washed sperm pellet. If the test's result is reported negative (Undetectable), the sample will send for Intra-Cytoplasmic Sperm Injection (ICSI). Intervention 2: Control group: This study is a single arm clinical trial that has no control group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Minoo Mohraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6694 7984</telephone>
        <email>ircha@tums.ac.ir</email>
        <affiliation>Iranian research Center for HIV AIDS (IRCHA)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Minoo Mohraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1583</telephone>
        <email>ircha@tums.ac.ir</email>
        <affiliation>Iranian Research Center for HIV AIDS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
&#13;
Being Married; Men who living with HIV-1; The consent of both spouses; Uninfected women.&#13;
Exclusion criteria:&#13;
&#13;
Lack of consent; Serum Viral load of over 500 RNA copy number/ ml.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B20</hc_code>
      <hc_code>O82.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases</hc_keyword>
      <hc_keyword>Delivery by caesarean section, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this method, healthy and motile uninfected sperm cells are isolated from other cells. Semen samples will be loaded on a sperm washing medium gradient and then centrifuged. Finally healthy and motile uninfected sperm cells will deposit. For the next step, sperm pellet will be load on the bottom of a sterile tube which is filled with Ham's F10 and will be incubate for 30 minutes in 37 C temperature. Healthy and motile sperm cells will swim to the upper surface of medium, and concentrate there and will be isolated for next step. For evaluating of the effectiveness of the sperm washing, viral load counting (Real Time PCR) will be done on a part of the washed sperm pellet. If the test's result is reported negative (Undetectable), the sample will send for Intra-Cytoplasmic Sperm Injection (ICSI).</i_keyword>
      <i_keyword>Control group: This study is a single arm clinical trial that has no control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother infection status. Timepoint: Before the first-trimester, second-trimester and third-trimester of pregnancy. Method of measurement: Laboratory tests.</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>Resaerch Deputy of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-03-08</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Central building of TUMS, Ghods St, Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
