<?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>IRCT20180528039878N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-19</date_registration>
      <primary_sponsor>Mehr medical institute</primary_sponsor>
      <public_title>Evaluation of the efficiency of clomiphene citrate plus letrozole on intrauterine insemination outcome</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficiency of clomiphene citrate plus letrozole gonadotropins for superovulation in patients undergoing intrauterine insemination: a randomized trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>501</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32566</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used to allocate participants into the three groups (with allocation ratio of 1:1:1).</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will receive clomiphene citrate (100 mg, Iran Hormone) on cycle day 3-7 ( for 5 days). Intervention 2: Intervention group: Group B will receive Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 days). Intervention 3: Intervention group: Group C will receive clomiphene citrate (100 mg, Iran Hormone) and Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is still no planning to share and publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Mehrafza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4178613111</zip>
        <telephone>+98 13 3376 4270</telephone>
        <email>marzieh.mehrafza@gmail.com</email>
        <affiliation>Mehr medical institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Mehrafza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4178613111</zip>
        <telephone>+98 13 3376 4270</telephone>
        <email>marzieh.mehrafza@gmail.com</email>
        <affiliation>Mehr medical institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age ≤ 38 years•
Basal FSH level &lt;10
Patients without history of allergic reactions to clomiphene
Mild male factor infertility
Unexplained infertility
Anovolatory patients who have not been pregnant despite the use of ovulation induction techniques and appropriate follicles</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No response to ovulation induction
Patients with large number of follicles who cannot receive hCG</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</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>Intervention group: Group A will receive clomiphene citrate (100 mg, Iran Hormone) on cycle day 3-7 ( for 5 days)</i_keyword>
      <i_keyword>Intervention group: Group B will receive Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 days)</i_keyword>
      <i_keyword>Intervention group: Group C will receive clomiphene citrate (100 mg, Iran Hormone) and Letrozole (5 mg, SOHA, Iran) on cycle day 3-7 (for 5 days)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: Seven weeks after intrauterine insemination. Method of measurement: Observation of gestational sac on transvaginal ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of follicles ≥ 18 mm. Timepoint: On hCG  administration day. Method of measurement: By transvaginal ultrasound.</sec_outcome>
      <sec_outcome>Follicular size on hCG day. Timepoint: On hCG  administration day. Method of measurement: By transvaginal ultrasound.</sec_outcome>
      <sec_outcome>Duration of ovarian stimulation. Timepoint: At the end of ovarian stimulation. Method of measurement: Number of days.</sec_outcome>
      <sec_outcome>Endometrial thickness on hCG administration day. Timepoint: On hCG  administration day. Method of measurement: By transvaginal ultrasound.</sec_outcome>
      <sec_outcome>Gonadotropin dosage. Timepoint: At the end of ovarian stimulation. Method of measurement: International Units.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Rasht University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mehr medical institute</source_name>
      <source_name>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-07</approval_date>
        <contact_name>ٍEthical committee of Guilan university of medical sciences</contact_name>
        <contact_address>Mehr Fertility Research Center, Mehr Medical Institute, Ershad St., Shahid Ansari Blvd., Rasht, Iran. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
