<?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>IRCT20230305057626N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-09</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating counseling with a solution-focused approach on the satisfaction and quality of sexual life of women with polycystic ovary syndrome with a history of failure of assisted reproductive techniques</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of solution-focused counseling on sexual satisfaction and sexual quality of life in women affected by polycystic ovarian syndrome with a history of failure of assisted reproductive techniques</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The student will select the number of 60 women based on the entry and exit criteria randomly and through the online software (www.Random.org/sequences) and written informed consent will be obtained to participate in the study. Then, patients are assigned to two groups of 30 people using a random number table, including the intervention group (consultation with a solution-oriented approach) and the control group (presentation of educational booklets). Again, the intervention group is divided into two subgroups by simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual satisfaction and quality counseling.</hc_freetext>
      <i_freetext>Intervention group: The intervention in the test group is counseling with a solution-oriented approach, which will be presented in 8 sessions in the Sky Room. The intervention (counseling with a solution-oriented approach 5A) is carried out by a master's student in counseling in midwifery under the supervision of a supervisor and a consultant. The content of the sessions includes introduction, introduction of group rules, measuring and evaluating the level of communication, introduction of solution-oriented treatment, melting the ice. and familiarizing the members with the goals and logic of the work (session 1), familiarizing with the basic principles of solution-oriented counseling and its application - examining the active acceptance of responsibility in a relationship - formulating problem solving circles - describing the problem objectively and away from tendencies and behaviors uncomfortable (session 2), identifying the solutions of the participants in different problem areas - familiarizing the participants with useful solutions and repeating them and abandoning inappropriate solutions - finding a positive story (session 3), making the participants committed and hopeful for Solving the problem - identifying and solving the participants' resistance - talking about the future - talking about the tasks - using the technique of scaled questions (session 4), familiarizing the members with the exceptions to the problem - strengthening and highlighting the exceptions to the problem - making the participants understand the capabilities and abilities Self (Session 5), helping the participants to identify other ways of thinking, feeling and thinking tar rather than current problematic thinking, feeling and behavior – helping participants to admire rather than criticize each other – implementing the King of Keys technique (Session 6), helping participants to imagine a desired future and a better world helping participants to Getting out of the framework of the problem and identifying objective and desirable changes, using the technique of pretend assignments (session 7), summarizing the meetings and concluding - using graded questions (session 8).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All individual data of study participants can be shared after de-identification

When:
After printing the results

To whom:
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive it.

Conditions:
Scientific usege

Where to obtain:
mah_bokaie@yahoo.com

How to obtain:
One week after receiving the applicant's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Bokaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar St</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915817153</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>Mah_bokaie@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Bokaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar St.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915817153</zip>
        <telephone>+98 35 3728 0232</telephone>
        <email>Mah_bokaei@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
History of at least one failure of assisted reproductive techniques in infertile women with polycystic ovary syndrome according to the Rotterdam criteria and registered in the medical file of the Research Institute of Reproductive Sciences
Being Iranian
Ability to understand and speak Persian language and cooperate in doing assignments
Having an Android or IOS smart phone
Sharing bed with husband</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participating in concurrent sexual health-related intervention studies
Having children
Use of any drug or hormone affecting sexual performance within 60 days before the intervention
Existence of various types of severe mental disorders (psychosis, schizophrenia, etc.) under medical treatment based on the information of the medical record or her statements
The presence of chronic diseases such as overt diabetes, hypertension, cardiovascular disease, thyroid disease, kidney disease, etc.
Use of tobacco, drugs and alcohol according to the patient
Existence of stressful events during the last 6 months such as immigration, death of relatives, divorce</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z70.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Counseling related to sexual attitude</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in the test group is counseling with a solution-oriented approach, which will be presented in 8 sessions in the Sky Room. The intervention (counseling with a solution-oriented approach 5A) is carried out by a master's student in counseling in midwifery under the supervision of a supervisor and a consultant. The content of the sessions includes introduction, introduction of group rules, measuring and evaluating the level of communication, introduction of solution-oriented treatment, melting the ice. and familiarizing the members with the goals and logic of the work (session 1), familiarizing with the basic principles of solution-oriented counseling and its application - examining the active acceptance of responsibility in a relationship - formulating problem solving circles - describing the problem objectively and away from tendencies and behaviors uncomfortable (session 2), identifying the solutions of the participants in different problem areas - familiarizing the participants with useful solutions and repeating them and abandoning inappropriate solutions - finding a positive story (session 3), making the participants committed and hopeful for Solving the problem - identifying and solving the participants' resistance - talking about the future - talking about the tasks - using the technique of scaled questions (session 4), familiarizing the members with the exceptions to the problem - strengthening and highlighting the exceptions to the problem - making the participants understand the capabilities and abilities Self (Session 5), helping the participants to identify other ways of thinking, feeling and thinking tar rather than current problematic thinking, feeling and behavior – helping participants to admire rather than criticize each other – implementing the King of Keys technique (Session 6), helping participants to imagine a desired future and a better world helping participants to Getting out of the framework of the problem and identifying objective and desirable changes, using the technique of pretend assignments (session 7), summarizing the meetings and concluding - using graded questions (session 8)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measuring the quality of sexual life in women with polycystic ovary syndrome using fertility failure techniques. Timepoint: In the baseline, week 8 and in follow-up at the end of the study in week 12 in both groups. Method of measurement: Sex life quality questionnaire (Simond et al.).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Measuring sexual life satisfaction in women with polycystic ovary syndrome with a history of failure of assisted reproductive techniques. Timepoint: In the baseline, week 8 and in the follow-up study completion in week 12. Method of measurement: Larson sexual satisfaction questionnaire.</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>2023-02-28</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Yazd, Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
