<?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>IRCT20180305038953N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-15</date_registration>
      <primary_sponsor>Sarem Fertility and Infertility Research Center (SAFIR)</primary_sponsor>
      <public_title>Mannitol efficacy in ovarian hyper stimulation syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy Assessment of Mannitol vs Albumin in Management of Ovarian Hyperstimulation Syndrome – A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block, individual randomization, using software; not blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Ovarian hyper stimulation syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intravenous infusion of 500 ml Mannitol 20%  at the same time with 500 ml Glucose 5% using y-site over 4 hours daily or twice a day a (based on clinical responses). Intravenous solutions are the products of Shahid Ghazi (Tabriz- Iran) factories. Intervention 2: Control group: Intravenous infusion of 100g Human Albumin (5 vials of 20% Albumin) over 4 hours, repeating every 4 ti 12 hours (based on clinical responses). Albumin vials are the product of OCTAPHARMA AG- Switzerland.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All information on the main outcomes of the study is available for sharing.

When:
The beginning of the access period is 6 months after the publication of the results of the study.

To whom:
Official assessors of the research field of the Iran University of Medical Sciences (IUMS)

Conditions:
- To verify the accuracy of the analysis of the study
- Modeling for future studies
- Use for future meta analyzes

Where to obtain:
Sarem Fertility and Infertility Research Center (SAFIR)

How to obtain:
The official application to "Iran University of Medicalscience (IUMS)" will be communicated to the "Sarem Fertility and Infertility  Research Center (SAFIR)" after being approved by the competent authorities. After receiving the request, SAFIR will contact the applicant within 10 days to answer the questions.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Namdar Khanzedeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sarem fertility and Infertility Research Center (SAFIR), Sarem women's hospital, shahrak-e-Ekbatan, phase 3, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1396956111</zip>
        <telephone>+98 21 4467 0883</telephone>
        <email>dr.m_namdar@saremcrc.com</email>
        <affiliation>sarem Fertility and Infertility Research Center (SAFIR)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>AboTaleb Saremi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sarem Fertility and Infertility Research Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1396956111</zip>
        <telephone>+98 21 4467 0883</telephone>
        <email>saremiat@yahoo.com</email>
        <affiliation>Sarem Fertility and Infertility Research Center (SAFIR)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Severe ovarian htper stimulation syndrome</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patient dissatisfaction to participate in the study
History of / sensitivity to the used drug</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hyperstimulation of ovaries</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intravenous infusion of 500 ml Mannitol 20%  at the same time with 500 ml Glucose 5% using y-site over 4 hours daily or twice a day a (based on clinical responses). Intravenous solutions are the products of Shahid Ghazi (Tabriz- Iran) factories.</i_keyword>
      <i_keyword>Control group: Intravenous infusion of 100g Human Albumin (5 vials of 20% Albumin) over 4 hours, repeating every 4 ti 12 hours (based on clinical responses). Albumin vials are the product of OCTAPHARMA AG- Switzerland.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abdominal girth. Timepoint: Every morning. Method of measurement: Centimeter.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Every morning. Method of measurement: Digital scale; kilogram.</prim_outcome>
      <prim_outcome>Hematocrite. Timepoint: Every 8 to 24 hours based on clinical severity of symptoms. Method of measurement: Colormetry; Percent.</prim_outcome>
      <prim_outcome>Serum creatinine. Timepoint: Every 8 to 24 hours based on clinical severity of symptoms. Method of measurement: Milligram/deciliter.</prim_outcome>
      <prim_outcome>Serum sodium level. Timepoint: Every 8 to 24 hours based on clinical severity of symptoms. Method of measurement: Ion Selective Electrode (ISE); millimol/milliliter.</prim_outcome>
      <prim_outcome>Serum potassium level. Timepoint: Every 8 to 24 hours based on clinical severity of symptoms. Method of measurement: Ion Selective Electrode (ISE); millimol/milliliter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of hospitalization. Timepoint: At the end of hospitalization. Method of measurement: Number of days.</sec_outcome>
      <sec_outcome>Total cost of medicine used. Timepoint: At the end of drug therapy. Method of measurement: Total cost of medicine in Rials.</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>Sarem Fertility and Infertility Research Center (SAFIR)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-04</approval_date>
        <contact_name>Ethics committee of Iran University of medical Sciences (IUMS)</contact_name>
        <contact_address>Iran University of medical Sciences (IUMS), Hemmat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
