<?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>IRCT20250421065430N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-20</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Psychometric Evaluation of the Persian Version of the Fertility Intention Scale among Young Breast Cancer Survivors</public_title>
      <acronym></acronym>
      <scientific_title>Psychometric Evaluation of the Persian Version of the Fertility Intention Scale among Young Breast Cancer Survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89522</url>
      <study_type>observational</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fertility Intention.</hc_freetext>
      <i_freetext>Control group: "This study aims to psychometrically evaluate the Persian version of the Fertility Intention Scale for young female breast cancer survivors. Participants include women who have completed active breast cancer treatment, are in the follow-up phase, and according to the opinion of an oncology specialist, are of reproductive age and possess the cognitive ability and literacy in Persian. The research procedures will follow standard guidelines for translation and cultural adaptation of psychometric instruments. First, the questionnaire will be translated by two independent translators, and then a synthesized version will be prepared. Back-translation will be performed by two other translators, and the versions will be compared with the original text. Subsequently, a 10-member expert panel, including nursing faculty, oncology specialists, reproductive health researchers, and a psychometric expert, will evaluate the translated version for clarity, conceptual meaning, and cultural appropriateness, and will approve the pre-final version. Content validity will be assessed using CVR and CVI indices based on the opinions of 10 experts, and face validity will be examined qualitatively and quantitatively through 10 patients and 5 experts. Construct validity will be evaluated using exploratory and confirmatory factor analysis with standard fit indices. The instrument's reliability will be measured using Cronbach's alpha and test-retest (ICC). Finally, after confirming its psychometric properties, the Persian version of the scale will be ready for use in clinical and reproductive health research.".</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 En There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmadreza mozaffari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery; Arak University of Medical Sciences, Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۹۴۱-۷-۳۸۴۸۱</zip>
        <telephone>+98 993 943 7985</telephone>
        <email>ahmadmz.official@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi jafarimaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery; Arak University of Medical Sciences, Basij square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۹۴۱-۷-۳۸۴۸۱</zip>
        <telephone>+98 912 752 4244</telephone>
        <email>Nurse_science@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Young female breast cancer survivor with confirmed diagnosis by an oncologist.
Being of reproductive age (having regular menstruation and not having entered menopause).
No severe physical illnesses or psychiatric disorders that could impair the ability to respond (such as dementia or psychotic episodes).
Conscious willingness and consent to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of treatment or surgery that has led to the complete removal of reproductive organs (e.g., hysterectomy or bilateral oophorectomy).
Unwillingness of the participant to continue cooperation at any stage of the research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: "This study aims to psychometrically evaluate the Persian version of the Fertility Intention Scale for young female breast cancer survivors. Participants include women who have completed active breast cancer treatment, are in the follow-up phase, and according to the opinion of an oncology specialist, are of reproductive age and possess the cognitive ability and literacy in Persian. The research procedures will follow standard guidelines for translation and cultural adaptation of psychometric instruments. First, the questionnaire will be translated by two independent translators, and then a synthesized version will be prepared. Back-translation will be performed by two other translators, and the versions will be compared with the original text. Subsequently, a 10-member expert panel, including nursing faculty, oncology specialists, reproductive health researchers, and a psychometric expert, will evaluate the translated version for clarity, conceptual meaning, and cultural appropriateness, and will approve the pre-final version. Content validity will be assessed using CVR and CVI indices based on the opinions of 10 experts, and face validity will be examined qualitatively and quantitatively through 10 patients and 5 experts. Construct validity will be evaluated using exploratory and confirmatory factor analysis with standard fit indices. The instrument's reliability will be measured using Cronbach's alpha and test-retest (ICC). Finally, after confirming its psychometric properties, the Persian version of the scale will be ready for use in clinical and reproductive health research."</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fertility Intention. Timepoint: "After providing explanations to complete the questionnaire.". Method of measurement: Fertility Intention scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-04-18</approval_date>
        <contact_name>Ethics Committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery; Arak University of Medical Sciences, Basij square Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
