<?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>IRCT20160717028967N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Avicenna infertility center</primary_sponsor>
      <public_title>The effect of melatonin in patients with polycystic ovary syndrom</public_title>
      <acronym></acronym>
      <scientific_title>The effect of melatonin supplemention for ovarian stimulation cycles on sleep and mood and microinjection outcomes in patients with polycystic ovary syndrom</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two equal groups (A and B) based on a randomized six-block table that is designed by Random allocation software.</study_design>
      <phase>3</phase>
      <hc_freetext>Poly Cystic Ovary Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Melatonin 3 mg tablets (nature made company) daily with oral contraceptive pill and Folic Acid start from the third day of the menstrual cycle before stimulation of ovaries and are continued till the oocyte pick up after the ovarian stimulation with the antagonist method in the next menstrual  cycle(for 6 week). Intervention 2: Control group:  Oral contraceptives and folic acid start from the third day of menstrual cycle and oocyte pick up after ovarian stimulation with antagonist method will be performed in the next menstrual cycle.</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>Dr. Soheila Ansaripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>Soh.ansaripour@gmail.com</email>
        <affiliation>Avecinna infertility center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Soheila Ansaripour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>Soh.ansaripour@gmail.com</email>
        <affiliation>Avicenna infertility center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 to 40 years old
Having symptoms of polycystic ovary syndrome
candidate of micro-injection for infertility treatment</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Azospermia in sperm analysis of male partner
The use of alternative infertility treatment services
Uncontrolled medical condition
Abnormal karyotype
Uterine  abnormal anatomy
Immune and coagulation dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Poly cystic ovarian syndrome</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>Intervention group: Melatonin 3 mg tablets (nature made company) daily with oral contraceptive pill and Folic Acid start from the third day of the menstrual cycle before stimulation of ovaries and are continued till the oocyte pick up after the ovarian stimulation with the antagonist method in the next menstrual  cycle(for 6 week)</i_keyword>
      <i_keyword>Control group:  Oral contraceptives and folic acid start from the third day of menstrual cycle and oocyte pick up after ovarian stimulation with antagonist method will be performed in the next menstrual cycle</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of retrieved oocytes. Timepoint: on the day of oocyte pick up. Method of measurement: Microscopic Assessment of oocytes count by the embryologist.</prim_outcome>
      <prim_outcome>Fertilization rate. Timepoint: The fertilization rate will be checked on the day after sperm injection. Method of measurement: Is calculated as percentage transformation of micro injected oocytes in to two pronuclei.</prim_outcome>
      <prim_outcome>Number  of embryos. Timepoint: The time of the assessment is 3 days after fertilization. Method of measurement: Microscopic assessment of the embryes count by the embryologist.</prim_outcome>
      <prim_outcome>Sleep. Timepoint: Before the intervention and after 6 weeks. Method of measurement: Pittsburgh sleep quality index questionnaire,STOP  Bang questionnaire and insomnia severity index questionnair.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention and after 6 weeks. Method of measurement: Beck depression short Inventory.</prim_outcome>
      <prim_outcome>Quality of retrieved oocytes. Timepoint: on the day of oocyte pick up. Method of measurement: Microscopic assessment of the oocytes morphology by the embryologist.</prim_outcome>
      <prim_outcome>Quality of embryos. Timepoint: The time of the assessment is 3 days after fertilization. Method of measurement: Microscopic assessment of the embryes morphology by the embryologist.</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>Vice chancellor for research, Avicenna infertility center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-05</approval_date>
        <contact_name>Ethics committee of Avecinna infertility center</contact_name>
        <contact_address>Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
