<?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>IRCT20090526001952N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of two methods of cabergoline administration to prevent ovarian hyperstimulation syndrome in women with polycystic ovary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two cabergoline administration methods to prevent ovarian hyperstimulation syndrome (OHSS) in patients with polycystic ovary syndrome (PCO)  under IVF</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70355</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Our sample size is 200 people, with 100 people in each group. The randomization method used in this study will be the block randomization method developed by the statistics expert by using the STATA software in a randomization list format. Then, according to the randomization list, the type of intervention for each individual will be written on paper, and the paper will be put in a sealed envelope. Envelopes will be numbered according to the randomization list. The physician will examine the patient's eligibility, and if the patient is eligible, she will tell the hospital research assistant. The research assistant will then provide the sealed envelope to the physician, and the physician will begin the intervention according to the contents of the envelope.or, Blinding description: Because of the kind of intervention, The patient will be aware of the treatment. Outcomes assessor will not be informed about the kind of treatment A statistician who is unaware of the type of interventions in each group will analyze the data.</study_design>
      <phase>3</phase>
      <hc_freetext>Polycystic ovarian syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: At the same time as starting the GNRH antagonist, cabergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 15 days. Intervention 2: Intervention group2:In this group, at the same time as the trigger (GNRH agonist) begins, abergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 8 days.</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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashraf Moini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Hospital, Rashid Ave., Resalat Highway, Tehranpars, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7788 3283</telephone>
        <email>hosp_arash@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashraf Moini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arash Hospital, Rashid Ave., Resalat Highway, Tehranpars, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1653915981</zip>
        <telephone>+98 21 7788 3283</telephone>
        <email>hosp_arash@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of 18 to 45 years old
Patients with polycystic ovary syndrome
high level of anti-müllerian hormone (AMH) level (&gt; 3 ng/ml) and/or high antral follicle count (AFC)&gt;20</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to cabergoline
Not taking the drug completely
Stopping the drug due to side effects or drug sensitivity</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: At the same time as starting the GNRH antagonist, cabergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 15 days.</i_keyword>
      <i_keyword>Intervention group2:In this group, at the same time as the trigger (GNRH agonist) begins, abergoline 0.5 mg tablets (Aborihan Pharmaceuticals, Iran) are administered orally once a day for 8 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovarian hyperstimulation syndrome. Timepoint: Three days after pancture. Method of measurement: Ultrasound and clinical findings.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Checking the hematocrit level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the hematocrit level will be measured in Arash Hospital's laboratory with the (Counter SYSMEX KS-500i) device, and the device is calibrated every morning by the responsible expert.</sec_outcome>
      <sec_outcome>Abdominal circumference. Timepoint: Three days after ovum-pick up day. Method of measurement: The abdominal circumference is measured at the midpoint of the line between the rib or costal margin and the iliac crest in the midaxillary line by using tape measure.</sec_outcome>
      <sec_outcome>Patient’s satisfaction. Timepoint: 2 weeks after ovum-pick up day. Method of measurement: Patient satisfaction is assessed with a verbal scale of poor, satisfactory, good via telephone call.</sec_outcome>
      <sec_outcome>Serum creatinine level. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in the fasting state and and the level of serum creatinine will be measured in the laboratory of Arash hospital using the Hitachi 717 device and the Jaffe’s method.</sec_outcome>
      <sec_outcome>Serum sodium and potassium levels. Timepoint: Three days after ovum-pick up day. Method of measurement: 5 cc of blood is drawn in fasting state and the serum levels of sodium and potassium will be measured in the laboratory of Arash Hospital using the Automatic Electrolyte analyzer of AUDICOM company and the ion selective electrode (ISE)  method.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-27</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>Vice-Chancellor in Research Affairs-Tehran University of Medical Science, 6th floor, near Qods st, keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
