<?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>IRCT20231217060434N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-26</date_registration>
      <primary_sponsor>Faculty of Physical Education and Sport Sciences - University of Tehran</primary_sponsor>
      <public_title>The effects of exercise and supplement on infertile women with PCOS</public_title>
      <acronym></acronym>
      <scientific_title>The effect of high-intensity interval training and nanocurcumin consumption of microRNAs(miRNA) 29a-5P, 93 and Anti Mullerian Hormone(AMH)  in infertile women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Basic scienece, Randomization description: Forty beads are placed in a box numbered from 1 to 4. After accepting each patient and obtaining informed consent, one of the beads is randomly took out of the box, and people are classified into different groups based on the number on the beads, so that numbers 1 belong to the group of HIIT, numbers 2: nanoCurcumin supplement, Numbers 3: HIIT+nanocurcumin, numbers 4: placebo. In general, this will be done on 40 patients, Blinding description: The method of blinding will be in a way that the patients will be unaware of their treatment group, and the training-supplement group will receive nanocurcumin and the training-placebo group will receive capsules containing flour.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Polycystic ovary syndrome. Condition 2: Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: exercise-supplement. Subjects of the exercise-supplement group take one 80 mg capsule of nanocurcumin with a daily dose during the period.                                                          High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds. Intervention 2: Intervention group2: Exercise-placebo group. They receive capsules containing flour. Because the exercise + supplement group and the exercise group will both exercise together in the hall, the exercise group will also be given a placebo so that the two groups of patients do not notice the difference between people.                                                           High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds. Intervention 3: Intervention group 3: supplementary group. Subjects in the supplement group will take 80 mg nanocurcumin capsules at a daily dose during the period. Intervention 4: Control group: Also, the control group will use a placebo (containing flour, but if not used, the people in the control group will be prone to celiac disease).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to participants' demands and the condition of this matter to participate in the project and to protect their privacy, the data will be preserved, but in case of reasonable request from the relevant organizations or people, the information of the project will be available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir hossain Delshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>After Quds settlement, Al-Ghadir Boulevard, Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716146611</zip>
        <telephone>+98 25 3210 3693</telephone>
        <email>ah_delshad@yahoo.com</email>
        <affiliation>The University of Qom</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad reza kordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, between 15th and 16th street, North Kargar street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>37 - 88351730</zip>
        <telephone>+98 21 8802 1527</telephone>
        <email>mrkordi@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infertile women
Women with PCOS
Age between 20 and 38 years (fertility age)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular disease
Respiratory disease
Using hormonal drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</hc_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: exercise-supplement. Subjects of the exercise-supplement group take one 80 mg capsule of nanocurcumin with a daily dose during the period.                                                          High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds.</i_keyword>
      <i_keyword>Intervention group2: Exercise-placebo group. They receive capsules containing flour. Because the exercise + supplement group and the exercise group will both exercise together in the hall, the exercise group will also be given a placebo so that the two groups of patients do not notice the difference between people.                                                           High-intensity interval training starts with 80% HRmax and ends with 95% HRmax in the last weeks. These exercises are held 3 days a week and each training session lasts for 30 minutes (5 minutes of warming up, 15 minutes of training, 10 minutes of cooling down) and includes 4 hours. Each set consists of 4 movements, each of which is performed for 30 seconds with high intensity and takes 15 seconds.</i_keyword>
      <i_keyword>Intervention group 3: supplementary group. Subjects in the supplement group will take 80 mg nanocurcumin capsules at a daily dose during the period.</i_keyword>
      <i_keyword>Control group: Also, the control group will use a placebo (containing flour, but if not used, the people in the control group will be prone to celiac disease).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>MicroRNA 29a-5P. Timepoint: before the start of the intervention and 3 months after the intervention at the end of the work. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>Anti Mullerian Hormone. Timepoint: before the start of the intervention and 3 months after the intervention at the end of the work. Method of measurement: blood test.</prim_outcome>
      <prim_outcome>MicroRNA 93. Timepoint: before the start of the intervention and 3 months after the intervention at the end of the work. Method of measurement: blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body Mass Index. Timepoint: before the start of the intervention and 3 months after the intervention at the end of the work. Method of measurement: BMI formula.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Iranian academic center for education culture and research</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Faculty of Physical Education and Sport Sciences - University of Tehran</source_name>
      <source_name>Rouya Infertility Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-26</approval_date>
        <contact_name>Faculty of Physical Education and Sport Sciences - University of Tehran</contact_name>
        <contact_address>Faculty of Physical Education and Sport Sciences, between 15th and 16th street, North Kargar street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
