<?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>IRCT20180725040587N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-29</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on quality of life in patients with polycystic ovarian syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on quality of life in patients with polycystic ovarian syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization using software Sample Randomizer, Blinding description: The study will be blind-doubled. In this way, patients will be blinded according to the type of intervention. Patients participating in the study will not know whether the pressure points are real acupressure points or false points. Also statistical analyst about the data of the intervention group (real points of acupressure) and the control group (false points of acupressure)
Will not know.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Polycystic ovary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention in group A (real points of acupressure) for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, (SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector. Intervention 2: Control group: intervention in group B (false points of acupressure), for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor Naza Afrin Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasouj University of Medical Sciences،School of Nursing and Midwifery Zeinab Yasouj</address>
        <city>Yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>hosseinichenar@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nazafarin Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasouj University of Medical Sciences،School of Nursing and Midwifery Zeinab Yasouj</address>
        <city>Yasouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>75919-94799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>hosseinichenar@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>By the gynecologist, polycystic ovarian syndrome has been confirmed
Marital status
Earning the minimum basic score (1.3 points for the correction version of the quality of life questionnaire related to health of polycystic ovary syndrome), Quality of life questionnaire 12 questions, minimum score 24-12
Absence of male infertility (confirmed by spermogram test)
Having ages 45-15 years</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having any systemic or endocrine and neurological disease based on the patient's question including: cardiovascular disease, type 1 and type 2 diabetes, neoplastic diseases including Cushing's syndrome, congenital adrenal hyperplasia and hyperprolactinemia (approved by a specialist)
Addiction to hookah, cigarettes, drugs and alcohol according to the research unit
Taking any hormonal medication except clomiphene
Presence of male infertility (confirmed by spermogram test)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Polycystic ovarian syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention in group A (real points of acupressure) for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, (SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector.</i_keyword>
      <i_keyword>Control group: intervention in group B (false points of acupressure), for a month and a half (equivalent to 12 sessions) twice a week, each session for one hour (each point 5 minutes including points REN-3, REN-4, IV3 L, SP10, SP6) and will start with the amount of pressure to the extent that the pressure point is anesthetized. The location of acupressure points and false points will be determined by a laser point detector</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life in Patients with Polycystic Ovary Syndrome. Timepoint: Before the intervention, three months after the intervention. Method of measurement: Modified Polycystic Ovary Syndrome Health-Related Quality Of Life Questionnaire (MPCOSQ) ،Short Form12 (SF-12).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hirsutism. Timepoint: Before intervention, three months after the intervention. Method of measurement: Friedman Galway Scale.</sec_outcome>
      <sec_outcome>Acne. Timepoint: Before intervention, three months after the intervention. Method of measurement: Global Acne Grading System (GAGS).</sec_outcome>
      <sec_outcome>Alopecia. Timepoint: Before intervention, three months after the intervention. Method of measurement: Ludwig scale.</sec_outcome>
      <sec_outcome>Total Testosterone. Timepoint: Before intervention, three months after the intervention. Method of measurement: NG/L.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-20</approval_date>
        <contact_name>Ethics Committee in Yasouj University of Medical Sciences</contact_name>
        <contact_address>Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
