<?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>IRCT20220702055335N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-06</date_registration>
      <primary_sponsor>Vice chancellor for Research,Tabriz University Of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of Dual Follicle Stimulating Hormone(FSH)/Human Chorionic Gonadotropin hormone(HCG) triggering on the success rate ofIntrauterine insemination (IUI) in couples diagnosed with unexplained infertility.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of Dual FSH/HCG triggering on the success rate of IUI in couples diagnosed with unexplained infertilityEvaluation of the effect of Dual Follicle Stimulating Hormone(FSH)/Human Chorionic Gonadotropin hormone(HCG) triggering on the success rate ofIntrauterine insemination (IUI) in couples diagnosed with unexplained infertility.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization and blinding will be done using the RANDOM.ORG website.Thus, for each patient, a number from 1 to 80 will be given And then, it will be obtained by the relevant site and by entering the range of random numbers.The obtained numbers will be assigned equally to two groups, Blinding description: Patients will be divided randomly into two groups (A and B).The data collection form will be provided to the analyzer with the header A and B without mentioning the type of method performed on the patient. The results of the data analysis, will be provided to the analyst without mentioning the name of the method (group A and B) to examine the consequences.So, these people will be blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: after checking the state of the ovaries and ensuring the presence of at least one mature follicle larger than 18 mm (between one and five follicles) and a suitable endometrium with a thickness of at least 7 mm, two ampoules of human chorionic gonadotropin hormone(HCG) 5000 intramuscular units (manufactured by Poyesh Pharmaceutical Company Daru, Iran) along with 150 units of (follicle stimulating hormone) FSH (Two ampoules of 75 units of Cinnal F) (manufactured by Shafayab Gostar Company) are also received subcutaneously. 34 to 36 hours later, Intrauterine insemination (IUI) is performed as usual. Intervention 2: Control group: after checking the state of the ovaries and ensuring the presence of at least one mature follicle larger than 18 mm (between one and five follicles) and a suitable endometrium with a thickness of at least 7 mm, two ampoules of human chorionic gonadotropin hormone(HCG) 5000 intramuscular units (manufactured by Poyesh Pharmaceutical Company) Daru, Iran) will be injected intramuscularly. 34 to 36 hours later,  Intrauterine insemination (IUI) is performed as usual.</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 After the completion of the project, the decision will be made.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Parvin Hakimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 35519161</telephone>
        <email>lahroudin@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Parvin Hakimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University Of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138665793</zip>
        <telephone>+98 35519161</telephone>
        <email>lahroudin@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having an informed consent to participate in the study
Unexplained infertility diagnosis
The health of the uterus structure
Normal pap smear test
Normal sperm analysis
Women between 20 and 38 years old</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>38 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Moderate to severe endometriosis
Hyper prolactinemia
Hyperthyroidism
Hypothyroidism
Ovarian Cysts
Kidney and liver failure
Secondary infertility</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</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: after checking the state of the ovaries and ensuring the presence of at least one mature follicle larger than 18 mm (between one and five follicles) and a suitable endometrium with a thickness of at least 7 mm, two ampoules of human chorionic gonadotropin hormone(HCG) 5000 intramuscular units (manufactured by Poyesh Pharmaceutical Company Daru, Iran) along with 150 units of (follicle stimulating hormone) FSH (Two ampoules of 75 units of Cinnal F) (manufactured by Shafayab Gostar Company) are also received subcutaneously. 34 to 36 hours later, Intrauterine insemination (IUI) is performed as usual.</i_keyword>
      <i_keyword>Control group: after checking the state of the ovaries and ensuring the presence of at least one mature follicle larger than 18 mm (between one and five follicles) and a suitable endometrium with a thickness of at least 7 mm, two ampoules of human chorionic gonadotropin hormone(HCG) 5000 intramuscular units (manufactured by Poyesh Pharmaceutical Company) Daru, Iran) will be injected intramuscularly. 34 to 36 hours later,  Intrauterine insemination (IUI) is performed as usual.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical pregnancy rate. Timepoint: 28 days after transfer. Method of measurement: Vaginal sonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical pregnancy rate. Timepoint: 14 days after transfer. Method of measurement: BhCG test.</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,Tabriz University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-01</approval_date>
        <contact_name>Ethics Committee Of Tabriz University Of Medical Sciences</contact_name>
        <contact_address>Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
