<?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>IRCT20181031041519N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Myo-inositol on the treatment of male infertility in couples under IUI</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Myo-inositol on Sperm Parameters and Fertility Rate in Patients with Oligoasthenospermia Treated with IUI: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: - Patients were randomly divided into two groups using Excel software
- We used stratified randomization
- Each code contained in sealed envelopes was provided to clinical care, Blinding description: Patients are divided into two groups of case and control according to the random numbers table, and patient, the physician and responsible for examining the sperm parameters didnt know which sample containing or not containing inositol.</study_design>
      <phase>3</phase>
      <hc_freetext>Male infertility due to oligoastenospermia.</hc_freetext>
      <i_freetext>Intervention 1: Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups.  Intervention Group: in the semen of this group, add .5 milliliter of myoinositol at a concentration of 2 mg/ml and incubate for 37 °C in the incubator for 2 hours. Intervention 2: Control group: Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups.  Control Group: in the semen of this group not add myoinositol, but only incubate for 37 °C in the incubator for 2 hours.</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 I will decide upon the completion of the residency</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyedeh Tahereh Ghazi mirsaeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no8.colop 18 Ally.imam montazer St.Satarkhan St</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1444933611</zip>
        <telephone>+98 21 8826 5089</telephone>
        <email>dr.ghazi83@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr.zahra doroodian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasul akram Hospital Satarkhan St</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6655 9595</telephone>
        <email>dr.ghazi83@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Couples who have not been pregnant for one year
In the studies included hysterosalpingography and hormonal testing all women were uncomplicated
Men have oligo or asthenospermia.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>38 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sever male factor (Oligo Stoenou men)
Untreated hormonal problem
BMI higher than 35
The age of a woman is over 38 years old</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>Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups.  Intervention Group: in the semen of this group, add .5 milliliter of myoinositol at a concentration of 2 mg/ml and incubate for 37 °C in the incubator for 2 hours.</i_keyword>
      <i_keyword>Control group: Semen sample removed after 48-72h from the ejaculation method and then placed in a 37-degree incubator for 30 minutes. After liquefying the sample, the sperm analysis with gradient method (sill select plus)After the sperm separation step, the subjects were randomly divided into two groups.  Control Group: in the semen of this group not add myoinositol, but only incubate for 37 °C in the incubator for 2 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sperm motility    Morphology   Agglutination   Volume  Acidity   Duration of liquefaction Dfi. Timepoint: sperm sample day                                                              After sample incubation                                                              Two hours after treatment with myo-inositol. Method of measurement: Examination of sperm samples under a microscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fertility. Timepoint: Two weeks after iui. Method of measurement: Serum 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-21</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences.Hemmat Ave.Tehran Town tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
