<?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>IRCT201104032892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-04-03</date_registration>
      <primary_sponsor>Vice chancellor for research,  Islamic Azad University of karaj branch</primary_sponsor>
      <public_title>Effect of diet and exercise program to improve polycystic ovary syndrome (PCOS)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effects of diet and exercise program to improve clinical symptoms and laboratory tests in obese women with polycystic ovary syndrome (PCOS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-01-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2777</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: Diet and exercise program &#13;
Diet plan: at the beginning of study a check list prepared for each individual and weekly regimen recommended separately based on feeding patterns and individual facilities. The method of regimen calculation based on total energy for each individual (TEE). We set the countable energy for reducing weight 1000 grams per week. Reduced the amount of energy and some energy into the physical activity to lose weight fraction are obtained. The combination of energy, including 40% carbohydrate, 30% fat (less than 8% saturated fatty acids was) and 30% protein is high physiological value. &#13;
 Fitness program: exercise sessions that included 24 meeting which duration per session was variable according to the program. For improving aerobic energy system and strengthen cardiovascular system a series exercises (slow jogging) will be used. &#13;
At the beginning of the first practice sessions will be used slow intensity aerobic exercise. The first training sessions with 5 minutes of times, and 50 percent of maximum heart rate of cholera in the form alternating between resting half the time repeating the exercise. &#13;
In each session we were trying to follow the principle of overload for improving cardiovascular efficiency. In higher stages (after the fifth session) of the repetition of exercises with some 60 percent of maximum heart rate is achieved. &#13;
Of the ninth session, training intensity reaches to 70 percent of maximum heart rate and in last sessions with 80 percent maximum heart rate do their exercise. In each session, subjects in the first 10 minutes to warm the body and also the final 10 minutes of cooling down exercises and return to the initial state. Intervention 2: For controls group: The standard drugs &#13;
Diane:  from fifth Day of cycle for 21 days every night, once a day &#13;
Spironolactone: 25 mg twice a day.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mani Mirfeizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculity of Nursing &amp; Midwifery, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00982614403254; 00982614182580; 00982614455635</telephone>
        <email>Mani@kiau.ac.ir; Manimirfeizi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mani Mirfeizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculity of Nursing &amp; Midwifery, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00982614403254; 00982614182580; 00982614455635</telephone>
        <email>Man@kiau.ac.ir; Manimirfeizi@yahoo.com</email>
        <affiliation>Islamic Azad University Karaj branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1- Participants have body mass index≥ 25 kg/ m2; 2- All Participants treat with same dose of oral contraceptives pill and spirnolacton; 3- All Participants have  menstrual pattern as oligomenorrhea (irregular bleeding episodes with intervals occur more than 35 days); 4- All Participants have suffered some degree of hirsutism.&#13;
Exclusion criteria:&#13;
1- Use of any drug other than the standard drug for the treatment of polycystic ovary syndrome, which is the same for everyone. (Including drugs to treat infertility, diabetes, hormonal drugs, reduce appetite and etc);  2- Smoking;  3- Being in pregnancy and lactation period or pregnancy decision; 4- Having cardiovascular, renal, liver, respiratory diseases, diabetes, uncontrolled hypertension, malignancy or any other acute or chronic disease;  5- Prohibition of the exercise due to illness or any other cause according to physician order;  6- Participating in regular exercise before the start of the study; 7- Having a separate diet programs before the start of the study.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocrine, nutritional and metabolic diseases(E00-E90)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: Diet and exercise program &#13;
Diet plan: at the beginning of study a check list prepared for each individual and weekly regimen recommended separately based on feeding patterns and individual facilities. The method of regimen calculation based on total energy for each individual (TEE). We set the countable energy for reducing weight 1000 grams per week. Reduced the amount of energy and some energy into the physical activity to lose weight fraction are obtained. The combination of energy, including 40% carbohydrate, 30% fat (less than 8% saturated fatty acids was) and 30% protein is high physiological value. &#13;
 Fitness program: exercise sessions that included 24 meeting which duration per session was variable according to the program. For improving aerobic energy system and strengthen cardiovascular system a series exercises (slow jogging) will be used. &#13;
At the beginning of the first practice sessions will be used slow intensity aerobic exercise. The first training sessions with 5 minutes of times, and 50 percent of maximum heart rate of cholera in the form alternating between resting half the time repeating the exercise. &#13;
In each session we were trying to follow the principle of overload for improving cardiovascular efficiency. In higher stages (after the fifth session) of the repetition of exercises with some 60 percent of maximum heart rate is achieved. &#13;
Of the ninth session, training intensity reaches to 70 percent of maximum heart rate and in last sessions with 80 percent maximum heart rate do their exercise. In each session, subjects in the first 10 minutes to warm the body and also the final 10 minutes of cooling down exercises and return to the initial state.</i_keyword>
      <i_keyword>For controls group: The standard drugs &#13;
Diane:  from fifth Day of cycle for 21 days every night, once a day &#13;
Spironolactone: 25 mg twice a day</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum testosterone(total &amp; free). Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</prim_outcome>
      <prim_outcome>Serum Dehydroepiandrosterone Sulphate (DHEAS). Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</prim_outcome>
      <prim_outcome>Serum sex hormone binding globulin (SHBG). Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</prim_outcome>
      <prim_outcome>Body mass index(BMI). Timepoint: Before intervention - three months after intervention. Method of measurement: By measuring the height (m) and weight (kg).</prim_outcome>
      <prim_outcome>Hirsutism. Timepoint: Before intervention - three months after intervention. Method of measurement: Using Friedman and Galway scale.</prim_outcome>
      <prim_outcome>Oligomenorrhea. Timepoint: Before intervention - three months after intervention. Method of measurement: Considering the menstrual cycle (irregular bleeding episodes with intervals of more than 35 days).</prim_outcome>
      <prim_outcome>Ovary status. Timepoint: Before intervention - three months after intervention. Method of measurement: using abdominal ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum Progestron. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum LH. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum FSH. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum stradiol. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum prolactin. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum T3. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum T4. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</sec_outcome>
      <sec_outcome>Serum TSH. Timepoint: Before intervention - three months after intervention. Method of measurement: Serological test with Electro Komolomynsans method with using of the company's ROCHE kits.</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>Vice chancellor for research,  Islamic Azad University of karaj branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-07-18</approval_date>
        <contact_name>Ethics Committee of  Islamic Azad university Karj barnch</contact_name>
        <contact_address>Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Mailbox: 31485-313 Karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
