<?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>IRCT2014081018662N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-21</date_registration>
      <primary_sponsor>Avicenna Infertility Clinic</primary_sponsor>
      <public_title>Effect of vitamin E, vitamin D on treatment of infertility in PCOS patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of supplementation with vitamin E and vitamin D on serum and follicular fluid oxidative and anti oxidative stress factors, oocyte quality and ICSI outcomes in PCOS infertile women candidate for ICSI who referred to Infertility Clinic of Avicenna Research Center during 2014-2015</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16859</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Polycystic ovarian syndrome. Condition 2: Infertility.</hc_freetext>
      <i_freetext>Intervention 1: placebo of vit E once daily for 2 months. Intervention 2: pearl vit D,Biweekly for 2 months. Intervention 3: placebo  of vit D,biweekly for 2 months. Intervention 4: pearl vit E,400 IU,once daily for 2 months.</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. Farnaz Fatemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal st., Shariati avenu,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>f.fatemi@avicenna.ac.ir</email>
        <affiliation>Avicenna Infertility Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnaz Fatemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal st., Shariati avenu,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>f.fatemi@avicenna.ac.ir</email>
        <affiliation>Avicenna Infertility Clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: PCOS patients based on ROTERDOM criteria; age:18-38 years old; day3 FSH level less than 12; BMI:20-34.  &#13;
Exclusion criteria: patients with heart, liver or renal disease; patients with Endometriosis; use of anticoagulats: ASA, Heparin, Warfarin; use of antidepresants:Fluoxetin, Certeralin; use of Statins: Levastatin, Atorvastatin; patients with Eye disease: Retinitis pigmentosa; use of anti inflammatory drugs and corticosteroids:prednisolon; use of vitamins and anti oxidants in 3 months ago; vit K deficiency and bleeding disorders; history of chemotherapy or radiotherapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
      <hc_code>Z31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sclerocystic ovary syndromeStein-Leventhal syndrome</hc_keyword>
      <hc_keyword>In vitro fertilization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>placebo of vit E once daily for 2 months</i_keyword>
      <i_keyword>pearl vit D,Biweekly for 2 months</i_keyword>
      <i_keyword>placebo  of vit D,biweekly for 2 months</i_keyword>
      <i_keyword>pearl vit E,400 IU,once daily for 2 months</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum malondealdehyde. Timepoint: before intervention and after intervention on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
      <prim_outcome>Serum total antioxidant capaity(TAC). Timepoint: before intervention and after intervention on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
      <prim_outcome>Serum super oxid dismuthase. Timepoint: before intervention and after intervention on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
      <prim_outcome>Follicular fluid malondealdehyde. Timepoint: on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
      <prim_outcome>Follicular fluid total anti oxidant capacity. Timepoint: on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
      <prim_outcome>Follicular fluid super oxid dismuthase. Timepoint: on the oocyte collection day. Method of measurement: American key man kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Oocyte quality. Timepoint: on the day of oocyte collection. Method of measurement: morphologic assesment with microscope.</sec_outcome>
      <sec_outcome>ICSI outcome. Timepoint: 2 weeks after embryo transfer. Method of measurement: serum BHCG.</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>Avicenna Infertility Clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-24</approval_date>
        <contact_name>Avicenna Research Institute Ethics Committee</contact_name>
        <contact_address>Avicenna Research Institute, Shahid Beheshti University, Velenjak Avenue, Chamran highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
