<?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>IRCT20201208049652N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-15</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Tranexamic acid injection effect at laparoscopic cystectomy</public_title>
      <acronym></acronym>
      <scientific_title>Evalution of tranexamic acid injection effect at laparoscopic cystectomy on AMH level in endometrioma patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52892</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: On the 30 small cards, the letter A is written and on the other 30 cards, the letter B is written. In the previous section, it was explained how the execution protocol is. Gives the operating room technician to select one of the cards and place the patient in one of the groups according to the same protocol and indicate the group on the patient information questionnaire. In this process, the surgeon and the researcher are blind to the group in which the patient is located. In other words, he becomes blind on both sides, Blinding description: On the 30 small cards, the letter A is written and on the other 30 cards, the letter B is written. In the previous section, it was explained how the execution protocol is. Gives the operating room technician to select one of the cards and place the patient in one of the groups according to the same protocol and indicate the group on the patient information questionnaire. In this process, the surgeon and the researcher are blind to the group in which the patient is located. In other words, he becomes blind on both sides.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Endometriosis , Laparoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cystectomy with tranexamic acid injection. Patients are randomly assigned to two groups of routine cystectomy without injection of tranexamic acid (A)  and the group with injection of tranexamic acid (B) and then cystectomy. After induction of anesthesia in group B patients at a rate of 10 mg / kg , body weight of the drug tranexamic acid is infused with 100 ml of 0.9% sodium chloride serum half an hour before surgery. During surgery, minimal interventions (such as sutures or the use of a catheter) are performed to maintain homeostasis to prevent a reduction in ovarian reserve. Cystectomy is then performed routinely. Surgery is performed by a surgeon. Intervention 2: Control group: (Group A) : Cystectomy without tranexamic acid injection. In group A (control), only 100 ml of 0.9% sodium chloride serum is infused without tranexamic acid and then cystectomy is performed by the same surgeon.</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:
After determining the results of the article printing program

When:
It is not clear.

To whom:
People allowed by Zahedan University of Medical Sciences .

Conditions:
People allowed by Zahedan University of Medical Sciences .

Where to obtain:
People allowed by Zahedan University of Medical Sciences .

How to obtain:
Correspondence with Zahedan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ebne Abitaleb Hospital</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5570</telephone>
        <email>dr.razavi351@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Ebne Abitaleb Hospital</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743111</zip>
        <telephone>+98 54 3329 5570</telephone>
        <email>dr.razavi351@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 18-40 years old with regular menstruation and endometrioma
Unilateral endometrioma cyst with 4-10 cm</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of previous ovarian surgery and pelvic adhesion
History of previous endocrinology diseases (Diabetes, Hyperprolactinoma )
PID
History of previous chemotherapy
History of previous PTE
Cyst other than endometrioma intraoperative
Cigarette Smoking , OCP consumption
Severe Renal Disease
Tranexamic acid injection contraindication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis</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>Intervention group: Cystectomy with tranexamic acid injection. Patients are randomly assigned to two groups of routine cystectomy without injection of tranexamic acid (A)  and the group with injection of tranexamic acid (B) and then cystectomy. After induction of anesthesia in group B patients at a rate of 10 mg / kg , body weight of the drug tranexamic acid is infused with 100 ml of 0.9% sodium chloride serum half an hour before surgery. During surgery, minimal interventions (such as sutures or the use of a catheter) are performed to maintain homeostasis to prevent a reduction in ovarian reserve. Cystectomy is then performed routinely. Surgery is performed by a surgeon</i_keyword>
      <i_keyword>Control group: (Group A) : Cystectomy without tranexamic acid injection. In group A (control), only 100 ml of 0.9% sodium chloride serum is infused without tranexamic acid and then cystectomy is performed by the same surgeon.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Antimullerian Hormone Level. Timepoint: 3 , 6 month. Method of measurement: ng/ml.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Antimullerian Hormone Level. Timepoint: 3 , 6 month. Method of measurement: ng/ml.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-21</approval_date>
        <contact_name>Zahedan University of Medical Sciences Ethic Committee</contact_name>
        <contact_address>Pardis of Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
