<?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>IRCT2013030312672N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-04-22</date_registration>
      <primary_sponsor>Shiraz  University Of Medical Sciences</primary_sponsor>
      <public_title>The effect vitamin C supplementation on infertile women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of vitamin C supplementation with balance diet, versus Placebo on the Luteinizing hormone, follicle-stimulating hormone, Dehydroepiandrosterone, testosterone, estradiol, progesterone and sex hormone-binding protein in infertile women with polycystic ovary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility, polycystic ovarian disease.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group in the early period of hormone tests performed and then 750 mg of vitamin C per day prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a placebo control group. Intervention 2: The control group in the early period of hormone tests performed and then placebo prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a 750 mg of vitamin C Intervention group .</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>Sadigheh Forouhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College Of  Nursing Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1242 4128</telephone>
        <email>Forouharism@yahoo.com</email>
        <affiliation>Shiraz College Of Nursing Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadigheh Forouhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College Of Nursing Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1242 4128</telephone>
        <email>Forouharism@yahoo.com</email>
        <affiliation>Shiraz College Of Nursing Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: People who are willing to cooperate؛ Having  2 of 3 criteria Rotterdam; Women with at least one year before entering the study had tried unsuccessfully to conceive; women aged 35-18 years; Do not use alcohol; Not used hormonal drugs within the last 2 months; No abnormal bleeding; Women who still have a normal uterus and tubal; Normal Spermogram man; Disorders related to reproductive hormones; no history of pelvic surgery; The absence of Laparoscopic Surgery; Body Mass Index between 19/8 to 29&#13;
exclusion criteria: Unwillingness to continue working; sensitivity to vitamin c; abnormal bleeding.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N.97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group in the early period of hormone tests performed and then 750 mg of vitamin C per day prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a placebo control group.</i_keyword>
      <i_keyword>The control group in the early period of hormone tests performed and then placebo prescribed treatment period lasted up to 22 days and then tested progesterone medication is discontinued. In the next cycle day 3 hormonal tests done again, this time as the 22 day period will receive a 750 mg of vitamin C Intervention group .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>LH. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>FSH. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>DHEAS. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Testosterone. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Estradiol. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>Progesteone. Timepoint: Day 22 of first cycle, Day 22 of the second cycle. Method of measurement: ELIZA.</prim_outcome>
      <prim_outcome>SHBG. Timepoint: Day 3 of the first menstruation, second cycle Day 3, Day 3 of the third period. Method of measurement: ELIZA.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shiraz  University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-14</approval_date>
        <contact_name>Ethics Committee, Shiraz University Of Medical Of Research , Ministry of Health</contact_name>
        <contact_address>Research Deputy, Shiraz  University of Medical Science Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
