<?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>IRCT2014123020486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-15</date_registration>
      <primary_sponsor>Research Deputy of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation intrauterine adhesion after uterine myoma surgery</public_title>
      <acronym></acronym>
      <scientific_title>Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18165</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>intrauterine synechia.</hc_freetext>
      <i_freetext>Intervention 1: All patients in intervention group underwent myomectomy by laparoscopy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia).&#13;
Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by control group (laparotomy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used. Intervention 2: All patients  in control group underwent myomectomy by laparotomy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia). Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by intervention group (laparoscopy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used.</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>Zahra Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Women's Hospital, Laparoscopy Department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 7773 3934</telephone>
        <email>dr.zahra.asgari@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leili Hafizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gynecology Department, Imam Reza Hospital, Ebnesina Street, Mashad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3802 2608</telephone>
        <email>hafizil@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: all of the married fertile women who had undergone myomectomy; having intra-mural and sub-serosal fibroids; types 3-6 (according to FIGO classification). &#13;
Exclusion criteria: receiving GnRH analogous; a history of uterine surgery; the presence of systemic conditions which increase the occurrence rate of synechiae such as genital tuberculosis, endometritis or post-operative fever of unknown origin; no desire to includr in the survey; patients for whom laparoscopy was contra-indicated due to the myoma size or other parameters.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N85.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified noninflammatory disorders of uterus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All patients in intervention group underwent myomectomy by laparoscopy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia).&#13;
Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by control group (laparotomy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used.</i_keyword>
      <i_keyword>All patients  in control group underwent myomectomy by laparotomy method. Surgeries were performed in the follicular phase of menstrual cycle (except for those with metrorrhagia). Surgery was performed under generalized anesthesia. Hysteroscopy was initially performed in order to determine the type of myoma and detect the intra-uterine pathology; if there was any, the patient would excluded of the survey. The myomectomy surgical technique was similar by intervention group (laparoscopy). For uterine suturing, the 1 and 0 vicryl suture was used. In the case of endometrial opening, 3 layers and in other cases 2 layers were used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intrauterine synechia. Timepoint: 3 months after myomectomy. Method of measurement: According to the modified classification of the European Society of Gynecological Endoscopy (ESGE).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation relationship between type, size and location of myoma with frequency and severity of intrauterine adhesion. Timepoint: 3 months after myomectomy. Method of measurement: Based on FIGO classification.</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>Research Deputy of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-02</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Centeral Organization of Tehran University of Medical Sciences, Across from Ghoda Street, Keshavarz Boulevard, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
