<?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>IRCT20200925048836N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation  the effect of vasopressin in ovarian endometriosis surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of vasopressin injection during operation of endometrioma on the ovarian reserve in reproductive age endometriotic women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51232</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Treatment of ovarian endometrioma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the intervention group, 5 cc of vasopressin solution(Hay press, Exir Pharmaceutical company, Iran) (10 milli intensive units in 20 cc of normal saline) is injected into the avascular part of meso ovarium and then  cystectomy is performed by an expert surgone with laparoscopic methods,the point of bleeding coagulated with bipolar Bissinger Medizintechnik device and amount of bleeding is recorded according to suction device content /milliliter, then the ovarian wall is sutured . Intervention 2: Control group: In the control group, without injection of vasopressin, ovarian cystectomy is performed by a skilled surgeon with laparoscopic method . Number of ovarian cauterization points that is performed wit Bissinger Medizintechnik bipolar device for homeostasis and the amount of bleeding during cyst removal is measured in milliliters that are collected in the suction device during surgery, then ovarian wall suturing is performed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Using vasopressine causes less bleeding and therefore does not reduce ovarian reserve after surgery

When:
Until the publication of the article

To whom:
Main and corresponding authors

Conditions:
With respect to inclusion and exclusion criteria

Where to obtain:
Main author

How to obtain:
Collected by the first author and evaluated by the documentary team and converted into statistical data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Alborzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Blvd, Faghihi Hospital, OB&amp;GYN central office</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>07134814336</zip>
        <telephone>+98 71 3233 2356</telephone>
        <email>alborzisa@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand Blvd, Faghihi Hospital</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>07134814336</zip>
        <telephone>0712332365</telephone>
        <email>elliaskary_md@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-45
With unilateral endometriosis of the ovaries undergoing cystectomy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Bilateral endometrioma
Menopausal women
Any contraindication for surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</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>Intervention group: in the intervention group, 5 cc of vasopressin solution(Hay press, Exir Pharmaceutical company, Iran) (10 milli intensive units in 20 cc of normal saline) is injected into the avascular part of meso ovarium and then  cystectomy is performed by an expert surgone with laparoscopic methods,the point of bleeding coagulated with bipolar Bissinger Medizintechnik device and amount of bleeding is recorded according to suction device content /milliliter, then the ovarian wall is sutured .</i_keyword>
      <i_keyword>Control group: In the control group, without injection of vasopressin, ovarian cystectomy is performed by a skilled surgeon with laparoscopic method . Number of ovarian cauterization points that is performed wit Bissinger Medizintechnik bipolar device for homeostasis and the amount of bleeding during cyst removal is measured in milliliters that are collected in the suction device during surgery, then ovarian wall suturing is performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovarian reserve. Timepoint: 0,3,6 Months post operation. Method of measurement: Blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of cauterization points needed for homeostasis. Timepoint: At time of operation. Method of measurement: The number of points that are catheterized by a bipolar Bissinger Medizintechnik device to perform homeostasis during a cystectomy is counted and recorded.</sec_outcome>
      <sec_outcome>The amount of bleeding (milliliter) in both groups were recorded. Timepoint: At time of operation. Method of measurement: Amount of bleeding (milliliter) is measured according to suction device measuring.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-14</approval_date>
        <contact_name>Shiraz Ethics Committee in Medical School Research</contact_name>
        <contact_address>Zand Blvd, Faghihi hospital OB&amp; GYN ward Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
