<?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>IRCT20110326006108N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-08</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of "SIT" Counseling for Infertile Individuals</public_title>
      <acronym>ICSI</acronym>
      <scientific_title>Effectiveness of internet-based stress inoculation therapy (ISIT) counseling approach on quality of life and stress related to infertility of women undergoing assisted reproductive treatment (ICSI).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: In the intervention group, counseling sessions based on the internet-delivered stress inoculation approach will be conducted as individual online counseling (ISIT). Participants in the control group will receive routine care and counseling through the fertility and infertility center's counseling unit, Randomization description: Using Random Allocation software, participants are randomly assigned to the intervention group (A) and the control group (B) via block randomization with a block size of 6.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention group: For this group, the internet-based stress inoculation counseling sessions will be conducted as individual online consultations (ISIT) via the "Zehn-e Aram" website, consisting of five 30-to-45-minute sessions over five consecutive weeks. Links to the counseling sessions will be sent weekly to intervention group members via SMS or the Eitaa messaging app. A student researcher will follow up by phone to ensure participants access the session links and complete the assigned exercises and tasks. All five sessions will be provided to the participants prior to the egg retrieval procedure..</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 Due to the confidentiality of the research topic, which is related to the infertility issues of infertile women, it is not possible to provide individual data of the participants.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hajar Pasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj-Afrouz Street, Babol, Mazandaran Babol University of Medical Sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11321995921</telephone>
        <email>h.pasha@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hajar Pasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ganj-Afrouz Street, Babol, Mazandaran Babol University of Medical Sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11321995921</telephone>
        <email>h.pasha@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent to participate in the study
Infertility as defined by the World Health Organization (WHO)
Physician-confirmed primary infertility
Iranian nationality
Age under 45 years
Basic literacy (ability to read and write)
Availability of spouse
Permanent marriage
Monogamous marriage (not in a polygamous relationship)
No adopted children
Women deemed candidates for assisted reproductive technology (ICSI) by a physician
Ownership of a smartphone
Familiarity with, and successful installation and setup of, the "Eitaa" messaging app on the smartphone
No history or current diagnosis of severe mental disorders (based on self-report or medical records), such as major depression, bipolar disorder, psychosis, or substance abuse
Not currently taking psychiatric medication
Not currently receiving counseling interventions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receipt of psychological support (participation in psychotherapy sessions, relaxation techniques, yoga) within the last 3 months
Experience of a stressful event in the last three months (death or acute illness of a close relative, major change in living circumstances)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For this group, the internet-based stress inoculation counseling sessions will be conducted as individual online consultations (ISIT) via the "Zehn-e Aram" website, consisting of five 30-to-45-minute sessions over five consecutive weeks. Links to the counseling sessions will be sent weekly to intervention group members via SMS or the Eitaa messaging app. A student researcher will follow up by phone to ensure participants access the session links and complete the assigned exercises and tasks. All five sessions will be provided to the participants prior to the egg retrieval procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in infertility. Timepoint: Before the intervention, immediately after, and 2 months after the end of the intervention. Method of measurement: The fertility quality of life tool (FertiQoL).</prim_outcome>
      <prim_outcome>Infertility-related stress. Timepoint: Immediately and 2 months after the intervention. Method of measurement: Fertility Problem Inventory (FPI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety and Depression Associated with Infertility. Timepoint: Before the intervention, immediately after, and 2 months after the end of the intervention. Method of measurement: Hospital Anxiety and Depressin Scale (HADS).</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-16</approval_date>
        <contact_name>Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganj-Afrouz Street, Babol Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
