<?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>IRCT2016092129909N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>interventions based on lifestyle modification</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation  the effectiveness of interventions based on life style modification in women with polycystic ovarian syndrom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>energy restricted low glycemic اindex  diet.</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:
Main consequences, statistical analysis

When:
The access period will start 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Use of statistical tests in the present research in similar studies, Use the main results of current research by citing references to the main authors to compare the results of the current research with the studies of others.

Where to obtain:
Email address
shishehgarf@yahoo.com

How to obtain:
6 months after the publication of the current research results, the information requested by the academic persons will be sent to their e-mail.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Shishehgar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard, Shahid Sattari Highway,  Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1477893855</zip>
        <telephone>+98 21 2243 2500</telephone>
        <email>fshishehgar@iaut.mu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Shishehgar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>floor 5, block 1, Islamic Azad University, Science and Research Branch, University Square, Shohada Hesarak Boulevard,  Shahid Sattari Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2240 9309</telephone>
        <email>fshishehgar@iaut.mu.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of PCOS according to Rotterdam criteria
All participants are Iranian speakers and have the ability to read and write
Age between 18-40 years old
BMI &gt; 25 kg / m² and &lt; 38 kg / m²</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>chronic disease
Using insulin-sensitizing drugs;
Using contraceptive drugs
Using antihypertensive drugs
Using lipid lowering drugs
Using any hormonal drugs
Using any antidepressants
Special diets or exercise for weight loss in past 6 months
Participating in previous similar studies
Ovulation induction in the past year
Smoking or using alcohol
Mental disorders
History of any type of malignancy
Being pregnant
Lactation in the past year
Bleeding of unknown cause</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E20-E35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of other endocrine glands</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>energy restricted low glycemic اindex  diet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Score in the Health Short Form Questionnaire (SF-36). Timepoint: 0-24 weeks. Method of measurement: The Short Form Health Survey(SF-36).</prim_outcome>
      <prim_outcome>Quality of Life Score in Polycystic Ovary Syndrome Questionnaire (PCOSQ). Timepoint: 0--24 weeks. Method of measurement: Polycystic Ovary Syndrome Questionnaire (PCOSQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hirsutism. Timepoint: 0-12-24 weeks. Method of measurement: Ferriman-Gallwey scoring.</sec_outcome>
      <sec_outcome>Menstural Cyclicity. Timepoint: 0-12-24 weeks. Method of measurement: Questionnare.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: 0-12-24 weeks. Method of measurement: non flexible tape measure.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: 0-12-24 weeks. Method of measurement: non flexible tape measure.</sec_outcome>
      <sec_outcome>Weight. Timepoint: 0-12-24 weeks. Method of measurement: digital scale.</sec_outcome>
      <sec_outcome>Hospital Depression and Anxiety Scale. Timepoint: 0-24 weeks. Method of measurement: Hospital Depression and Anxiety Scale.</sec_outcome>
      <sec_outcome>Self-esteem. Timepoint: 0-24 weeks. Method of measurement: Rosenberg Self-esteem Scale (RSES).</sec_outcome>
      <sec_outcome>ُSexual function. Timepoint: Female Sexual Function Index (FSFI). Method of measurement: 0-24 weeks.</sec_outcome>
      <sec_outcome>Body Shape Questionnaire. Timepoint: 0-24 weeks. Method of measurement: Body Shape Questionnaire.</sec_outcome>
      <sec_outcome>Multidimensional Body-self Relations Questionnaire (MBSRQ). Timepoint: 0-24 weeks. Method of measurement: Multidimensional Body-self Relations Questionnaire (MBSRQ).</sec_outcome>
      <sec_outcome>Binge Eating Scale (BES). Timepoint: 0-24 weeks. Method of measurement: Binge Eating Scale (BES).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-15</approval_date>
        <contact_name>Ethics committee of research institute for endocrine sciences, Shahid Beheshti Universityof Medical</contact_name>
        <contact_address>24 Parvaneh, Yaman Street, Velenjak, Tehran, I.R.Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
