<?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>IRCT20211127053188N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-25</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness comparison of relationship enhancement couple therapy versus systematic desensitization on sexual anxiety in infertility</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness comparison of online relationship enhancement couple therapy program versus systematic desensitization on sexual relationship anxiety in women undergoing infertility treatment with timed intercourse</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A total of 68 women under treatment with sexual anxiety are randomly assigned a number from 1 to 68. Using random allocation1 software, individuals are randomly assigned to two groups of Relationship Improvement Couple Therapy (RECT) and Regular Desensitization (SD) based on the software output table. Each group of 34 people is then randomly divided into two subgroups of 17 people. Blindness is not possible due to women's awareness of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual anxiety counseling.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 receives an online relationship enhancement couple therapy program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women. Intervention 2: Intervention group 2 receives an online systematic desensitization program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Afzal Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No. 40, Alley 16, Varzesh St., Shahrekord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815846679</zip>
        <telephone>+98 38 3333 0444</telephone>
        <email>afzal.midwife@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Afzal dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fourth floor, No. 40, Alley 16, Varzesh St.,Shahrekord</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815846679</zip>
        <telephone>+98 38 3333 0444</telephone>
        <email>afzal.midwife@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a primary infertility record in Hazrat Zahra Infertility Center in Shahrekord
Having sexual anxiety based on a sexual anxiety test questionnaire
Internet literacy and smartphone
Having a bed with his wife
Willingness to participate in this study
Iranian nationality
Fluency in Persian</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy
Ovarian Hyperstimulation Syndrome (OHSS)
Having neurological diseases and taking psychiatric drugs based on infertility records
Tragic events such as the death of loved ones in the last two months
Family quarrel in a recent month
Living in a place without internet access
Participate in psychological counseling sessions or similar studies over the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counselling related to sexual attitude, behaviour and orientation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 receives an online relationship enhancement couple therapy program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women.</i_keyword>
      <i_keyword>Intervention group 2 receives an online systematic desensitization program. Intervention sessions include 8 sessions of 60 minutes. The content of online sessions in the form of text, graphics, videos, clips, group chat and questions and answers in Skyroom is presented in groups. Homework and its evaluation by the second author is done under the supervision of the first and third authors in all sessions through WhatsApp. In case of absence of women up to two sessions, a summary of the content of these two sessions will be provided to absentees. Free weekly internet package is provided to women.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the mean scores of sexual anxiety in women undergoing infertility treatment. Timepoint: At baseline, when the intervention was completed at week 8 and at follow-up at study week 12 at the two groups. Method of measurement: Sexual Anxiety Scale (Davis et al.).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spouse satisfaction score of counseling method in two groups. Timepoint: At the end of the intervention at week 8 and at the end of the study at week 12. Method of measurement: Satisfaction  visual Scale with one question, score between 1-10.</sec_outcome>
      <sec_outcome>Pregnancy frequency. Timepoint: Fallow up week 12. Method of measurement: Pregnancy diagnosis 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-17</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>4th floor, corner of the alley, No. 40, Alley 16, varzesh Street, shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
