<?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>IRCT20260610069746N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-29</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Motivational Interviewing on decisional conflict, stress and hopelessness after one IVF failure</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Motivational Interviewing on decisional conflict, stress and hopelessness after one IVF failure of infertile women referring to molud infertility center in Zahedan in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90864</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: In this study, simple randomization was used. After assessing the inclusion and exclusion criteria and obtaining written informed consent, participants were randomly allocated to either the intervention group or the control group.
Unit of randomization: The individual participant was considered as the unit of randomization.
Stratification: Stratified randomization was not used in this study.
Randomization tool and generation of random sequence: The random sequence was generated using the lottery method. For this purpose, 60 identical folded papers were prepared, including 30 labeled “intervention group” and 30 labeled “control group”. All papers were placed in a container, and each participant randomly selected one paper. Based on the label on the paper, the participant was assigned to either the intervention or control group.
Allocation concealment:To ensure allocation concealment, the papers were identical, unmarked, and folded before being placed in the container. Therefore, neither the participants nor the researcher were aware of the group allocation until the paper was selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: stress. Condition 2: Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:This study was conducted at the Moloud Infertility Center in Zahedan. Participants were selected by convenience sampling from infertile women with one failed IVF attempt. After obtaining written informed consent, participants were randomly allocated to intervention and control groups using simple randomization (lottery method). The intervention group received four motivational interviewing sessions. Intervention 2: Control group:.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashahir Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816838192</zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>helennavaee@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashahir</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816838192</zip>
        <telephone>+98 54 3344 4510</telephone>
        <email>Navaee.M@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for the study: resident of Zahedan city; living with her spouse; having at least literacy in reading and writing; age between 20 and 45 years; at least 2 months passed since the failure of in vitro fertilization; having no living child or adopted child; not experiencing severe psychosocial crises during the past 6 months; not participating in any counseling program; having no history of psychological disorders and not using psychiatric medications; having frozen embryos stored at the infertility center; having no contraindication for performing in vitro fertilization again; having no history of remarriage; currently belonging to a monogamous family; at least one year has passed since their decision to become pregnant and they have not been successful; at least 6 months have passed since the diagnosis of infertility.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria from the study: not participating in more than one counseling session; occurrence of spontaneous pregnancy in the woman during the study; occurrence of any unpleasant event such as the death of loved ones.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:This study was conducted at the Moloud Infertility Center in Zahedan. Participants were selected by convenience sampling from infertile women with one failed IVF attempt. After obtaining written informed consent, participants were randomly allocated to intervention and control groups using simple randomization (lottery method). The intervention group received four motivational interviewing sessions.</i_keyword>
      <i_keyword>Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decision conflict. Timepoint: Before and one month after the intervention. Method of measurement: O’Connor’s Decision Conflict Questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before and one month after the intervention. Method of measurement: Newton’s Infertility Stress Questionnaire (Fertility Problem Inventory).</prim_outcome>
      <prim_outcome>Hopelessness. Timepoint: Before and one month after the intervention. Method of measurement: Beck hopelessness 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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-18</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Zahedan University of Medical Sciences, Khalije Fars Boulevard, Zahedan, Iran zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
