<?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>IRCT20210911052439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-03</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Ovarian reserve after abdominal hysterectomy.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ovarian reserve after abdominal hysterectomy with&amp; without bilateral salpingectomy in women in reproductive age.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58629</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of 30 using 6 blocks and a ratio of 1: 1. The free website www.randomization.com will be used for the allocation sequence. The obtained sequence will be written in separate sheets and will be placed in sealed envelopes and will be given to the main researcher for study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ectopic pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group underwent abdominal hysterectomy. After round ligament amputation, the eutrophic ligament was isolated instead of infendibliplovik and the ovary (one or both ovaries) was preserved and then the cardinal ligament and vaginal cuff were isolated according to the routine protocol of arterial and venous surgery. And the uterus and fallopian tubes come out. Intervention 2: Control group: Patients in this group undergo abdominal hysterectomy at the junction of the fallopian tubes and the uterine ligament and the fallopian tubes and ovaries (one or both ovaries and fallopian tubes) are preserved. And the uterus comes out.</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:
All procedures performed, including how patients are selected, laboratory procedures and ultrasound, and the procedure performed during surgery and how patients are followed up after the study will be shared.

When:
The access period will start one year after the results are published.

To whom:
Academics, researchers, and students, can access the study.

Conditions:
All analyzes are performed in order to make better and more use of the research and to upgrade the knowledge and surgical processes.

Where to obtain:
mahboobehmohammadpour@gmail.com
00989111191874

How to obtain:
After viewing the email and verifying the identity of the applicant, the data file will be provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboobeh Mohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshjoo5,.Keshavarz Blvd.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-59964</zip>
        <telephone>+98 11 3220 8726</telephone>
        <email>mahboobehmohammadpour@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azita Ghanbarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj afrooz Ave.,Keshavarz Blvd.,Babol.</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3223 8301</telephone>
        <email>a.ghanbarpour@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients in reproductive age without a history of oligomenorrhea who candidates for hysterectomy.
Patients with no menopausal symptoms and FSH levels less than 10 units / liter.
Patients who are candidates for abdominal hysterectomy without oophorectomy because of benign reasons.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients in premenopausal age.
Patients with a family history of genital or breast cancers.
Patients whose ovarian cysts have been reported in previous ultrasound examinations.
Patients who have a history of taking hormonal or ocp medications within two months before surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O00.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tubal pregnancy</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: Patients in this group underwent abdominal hysterectomy. After round ligament amputation, the eutrophic ligament was isolated instead of infendibliplovik and the ovary (one or both ovaries) was preserved and then the cardinal ligament and vaginal cuff were isolated according to the routine protocol of arterial and venous surgery. And the uterus and fallopian tubes come out.</i_keyword>
      <i_keyword>Control group: Patients in this group undergo abdominal hysterectomy at the junction of the fallopian tubes and the uterine ligament and the fallopian tubes and ovaries (one or both ovaries and fallopian tubes) are preserved. And the uterus comes out.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anti-Mullerian Hormone level. Timepoint: At the beginning of the study and three months after hysterectomy. Method of measurement: Chemiluminescence method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Follicle-stimulating Hormone (FSH) level. Timepoint: At the beginning of the study and three months after hysterectomy. Method of measurement: Chemiluminescence method.</sec_outcome>
      <sec_outcome>Number of antral follicles OF ovary. Timepoint: At the beginning of the study and three months after hysterectomy. Method of measurement: Sonography.</sec_outcome>
      <sec_outcome>Ovarian volume. Timepoint: At the beginning of the study and three months after hysterectomy. Method of measurement: Sonography.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-31</approval_date>
        <contact_name>Ethics committee of Babol university of medical sciences</contact_name>
        <contact_address>Daveshjoo 5, keshavarz Blvd. Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
