<?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>IRCT2013012512262N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-05</date_registration>
      <primary_sponsor>Tehran University of Medical Science,</primary_sponsor>
      <public_title>The effect of Vasopressin on decreasing  time of surgery</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of Vasopressin injection on decreasing  time  of  surgery  and  need  to  electrooagulation  for  hemostasis   during laparascopic cystectomy of patients refered to Zanan Hospital because of endometriomas</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ovarian Endometrioma.</hc_freetext>
      <i_freetext>Intervention 1: In case group,before the dissection of cyst wall ,3 mililiters containing 0.3 units diluted  vasopressin of an ampule of vasopressin named (Hypress) which contains 20 units of vasopressin and diluted 200 times by adding 200 mililiters normal salin will be injected in the space between cyst wall and ovary by the specific needle,the injection will be in one place near the grater vessels. Then, 50-70 mililiters normal saline will be injected in multiple points . The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis. Intervention 2: In control group,before the dissection of cyst wall , 50-70 mililiters of normal saline will be injected in multiple points in the space between cyst wall and ovary by the specific needle,the. Then, The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis.</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 Marzie Ghafarnejhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The Great Women Hospital, North Nejatolahi St, Krimkhane Zand Aven, Valliasr Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8890 0002</telephone>
        <email>ghafarin2@yahoo.com</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Marzie Ghafarnejhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The Great Women Hospital, North Nejatolahi St, Krimkhane Zand Aven, Valliasr Sq, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8890 0002</telephone>
        <email>ghafarin2@yahoo.com</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:female;18-35 years old; a unilateral ovarian endometrioma; regular menstrual cycles&#13;
exclusion criteria : female younger than 18;female older than 35;bilateral ovarian cyst;irregular menstural cycles; prior  ovarian  surgery ;usage of oral contraceptive pills before surgery;diagnosis of malignancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of ovary</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In case group,before the dissection of cyst wall ,3 mililiters containing 0.3 units diluted  vasopressin of an ampule of vasopressin named (Hypress) which contains 20 units of vasopressin and diluted 200 times by adding 200 mililiters normal salin will be injected in the space between cyst wall and ovary by the specific needle,the injection will be in one place near the grater vessels. Then, 50-70 mililiters normal saline will be injected in multiple points . The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis</i_keyword>
      <i_keyword>In control group,before the dissection of cyst wall , 50-70 mililiters of normal saline will be injected in multiple points in the space between cyst wall and ovary by the specific needle,the. Then, The cyst wall will be sent for pathological evaluation after stripping.Then the cyst`s bed would be assessed for bleeding and if needed electrocoagulation would be used for hemostasis</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Operation time. Timepoint: from the begining of dissection of the cyst wall till the complete dissection. Method of measurement: seconds.</prim_outcome>
      <prim_outcome>Electrocagulation to achieve hemostasis. Timepoint: during operation. Method of measurement: counting the number of it in the film of surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ovarian reserve. Timepoint: before and 2 months after surgery. Method of measurement: antral follicules by sonography.</sec_outcome>
      <sec_outcome>Bleeding rate. Timepoint: before and 72 houres later than surgery. Method of measurement: hemoglubin (mg/dl).</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>Tehran University of Medical Science,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-13</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>Tehran University of Medical Science, Poursina Ave, Keshavarz Blvd, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
