<?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>IRCT20220520054928N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-29</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Physiotherapy in thin endometrium</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of physical therapy manual techniques (visceral manipulation) on uterine endometrial thickness, pain and investigating the quality of sexual function in women in women with endometrial thickness less than 7 mm</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63703</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization by block, Blinding description: physical therapist.</study_design>
      <phase>3</phase>
      <hc_freetext>Thin uterus endometrium.</hc_freetext>
      <i_freetext>Intervention 1: Control group: vitamin E group of patients are randomly divided into intervention and control groups, there are twenty people in each group. In both control and treatment groups, vitamin E400 is taken orally twice a week. In addition to vitamin E, the intervention group also receives visceral manipulation techniques. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up. Intervention 2: Intervention group: Intervention group: In addition to vitamin E, visceral manipulation techniques are also performed in the intervention group. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up.</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:
Document with out name and number

When:
Start in six months after end of research

To whom:
University and academic research

Conditions:
Use od analysis process

Where to obtain:
USWR university

How to obtain:
Resquated in USWR.univercity

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mosslanezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Ave,Daneshjo Blvd,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14555858668</zip>
        <telephone>+98 21 2218 0032</telephone>
        <email>zmosallanezhad@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammedreza Norbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave,Daneshjo Blvd,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1455556585</zip>
        <telephone>+98 21 2218 8003</telephone>
        <email>hanyehhabibi2694@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Thickness od endometrium is lesser than 7mm
Patient is married</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Non malegnancy
Not pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N71.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inflammatory disease of uterus, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: vitamin E group of patients are randomly divided into intervention and control groups, there are twenty people in each group. In both control and treatment groups, vitamin E400 is taken orally twice a week. In addition to vitamin E, the intervention group also receives visceral manipulation techniques. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up.</i_keyword>
      <i_keyword>Intervention group: Intervention group: In addition to vitamin E, visceral manipulation techniques are also performed in the intervention group. In the intervention group, visceral manipulation techniques are used to treat patients. The number of treatment sessions is eight sessions for ten days, each session is 45 minutes. Each technique is performed 3 to 5 times in each session. After completing the treatment, the patients are evaluated again after two weeks of follow-up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Uterine endometrial thickness in women with endometrial thickness less than 7 mm. Timepoint: Assessment in  days of3_6in peroid cycle. Method of measurement: Sonography,visual analogue scale ,and form of sexual dysfunction.</prim_outcome>
      <prim_outcome>Pain higher than score five in visual pain measurement. Timepoint: At the beginning of the study and after the completion of treatment. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Investigating the quality of women's sexual performance using a sexual performance questionnaire. Timepoint: At the beginning of the study and after the completion of treatment. Method of measurement: Questionnaire form for assessing the quality of women's sexual performance.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Endometrial thickness,  and investigating the effect of physiotherapy in gynecological diseases and infertility. Timepoint: Post of treatment in 3_6days of perid. 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-20</approval_date>
        <contact_name>Ethics Committee of the University of Rehabilitation Sciences and Social Health</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd., Evin,  Velenjak.Tehran.Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
