<?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>IRCT2017012932284N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-07</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Babol University of Medical Science</primary_sponsor>
      <public_title>ٍEffect of human Chorionic Gonadotropin (hCG) on treatment of infertility</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding low dose human Chorionic Gonadotropin (hCG) to recumbinant Follicular Stimulating Hormone (rFSH) on follicular phase in women undergoing intracytoplasmic sperm injection cycle, a clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: In the first group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. Treatment with rFSH will continue until the creation of the oocytes. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU human Chorionic Gonadotropin (hCG) will inject. Thirty six hours later ovarian puncture is performed. Intervention 2: In the second group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When the follicle size become 14 millimeter, rFSH dose reduce to 75 IU per day and treatment starts with 100 IU human Chorionic Gonadotropin (hCG) per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed. Intervention 3: In the third group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When follicle size become 14 millimeter, treatment with rFSH stops and patient treat with 200 IU human Chorionic Gonadotropin per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed.</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 Maryam Yeganegi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rohani Hospital, Ganjafrooz Street, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3227 4880</telephone>
        <email>parastoo0847@yahoo.com</email>
        <affiliation>Babol University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Zahra Basirat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rohani Hospital, Ganjafrooz Street, Babol</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3223 8267</telephone>
        <email>basiratzahra@yahoo.com</email>
        <affiliation>Babol University of Medical  Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: 20 - 40 years old; 1 year history of infertility; candidate for intracytoplasmic sperm injection.&#13;
&#13;
Exclusion Criteria: history of chronic disease; abnormal salpingography.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>n97.0</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. Treatment with rFSH will continue until the creation of the oocytes. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU human Chorionic Gonadotropin (hCG) will inject. Thirty six hours later ovarian puncture is performed</i_keyword>
      <i_keyword>In the second group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When the follicle size become 14 millimeter, rFSH dose reduce to 75 IU per day and treatment starts with 100 IU human Chorionic Gonadotropin (hCG) per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed.</i_keyword>
      <i_keyword>In the third group patients treated with a dose of 150 International Unit (IU) recombinant Follicular Stimulating Hormone (rFSH) per day. When follicle size become 14 millimeter, treatment with rFSH stops and patient treat with 200 IU human Chorionic Gonadotropin per day. When at least two or three follicles 18 millimeter to 20 millimeter in size were formed; 100 IU hCG will inject. Thirty six hours later ovarian puncture is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Follicle size. Timepoint: Daily. Method of measurement: Ultrasonography - Milimeter.</prim_outcome>
      <prim_outcome>Mature oocyte. Timepoint: End of Cycle. Method of measurement: Sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ovarian Hyperstimulation Syndrome. Timepoint: Daily. Method of measurement: Sonography - Folicle size - Milimeter.</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, Babol University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-13</approval_date>
        <contact_name>Babol Univercity of Medical Sciences</contact_name>
        <contact_address>Rohani hospital, Ganjafrooz street, Babol Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
