<?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>IRCT20150119020719N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-14</date_registration>
      <primary_sponsor>Vice-Chancellor for Research in Alborz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling on stress and female behaviors of infertile women</public_title>
      <acronym></acronym>
      <scientific_title>Effect of group counseling on stress and gender role attitude of infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29348</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Use the random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 7 non-Bargain women are grouped together in five groups of seven, and a two-hour counseling session for 5 sessions (90 minutes), delivered in a speech, question and answer file, according to the British Infertility Advice Protocol, gender role attitude, rights and health Fertility will be advised and followed up by phone call. To avoid facing the control and intervention group, it is attempted to arrange classrooms on different days of the week and in coordination with contributors through telephone conversations. Session 1: The purpose of the study, the presentation of information on infertility, the emotional consequences of infertility, how to create them and their relationship with infertility, methods and treatment protocol, drug side effects, success rate, how to use drugs and their side effects Second session: how to donate gametes and Embryo, fertility storage, uterus rental, talking about sexual problems, identifying women's thoughts and centralized feelings about infertility by discussing group discussions and expressing their opinions and exercising relaxation 9. (1. Mind-to-Muscle Technique 2. Technique Muscle to mind) Session 3: Helping to adapt to conditions, stress and sexual performance, exercises of lawmaking with reflection of the mind The focus is on women's respiration, based on the BIRITISH protocol and relaxation practice. Fourth part: 10, the expression of women's rights and discussion of other roles of women in life and practice of relaxation. The fifth session: the summing up of past sessions and the way Stress control (advise on exercise, especially hiking, starting a new pastime, meditating, and eating a stress relieving diet) and relaxation exercises. The sessions will be validated by the faculty members of the midwifery department at the university. Intervention 2: Control group: In the control group, no advice is given to individuals, and at the end of the workbook, the contents of the stress control methods are given to both groups (control and intervention).</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 participant data can be shared after unidentifiable

When:
Start the access period after printing the results

To whom:
Public

Conditions:
For use in studies allowed.

Where to obtain:
z.ehsan90@gmail.com

How to obtain:
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>Alborz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Esmaelzadeh Saeieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery-Golestan-i-Baghestan-Alborz-Iran</address>
        <city>alborz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 623 2569</telephone>
        <email>esmaelzadeh1360@gmail.com</email>
        <affiliation>دانشگاه علوم پزشکی البرز</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have medical diagnosis based on infertility
Iranian nationality
Fluent in Persian
Infertility with female factor
At least the reading and writing skills
Age between 18_44 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having psychiatric issues, according to one's own words
Infertility with male factor
Not attending 5 at least 3 sessions of counseling sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 7 non-Bargain women are grouped together in five groups of seven, and a two-hour counseling session for 5 sessions (90 minutes), delivered in a speech, question and answer file, according to the British Infertility Advice Protocol, gender role attitude, rights and health Fertility will be advised and followed up by phone call. To avoid facing the control and intervention group, it is attempted to arrange classrooms on different days of the week and in coordination with contributors through telephone conversations. Session 1: The purpose of the study, the presentation of information on infertility, the emotional consequences of infertility, how to create them and their relationship with infertility, methods and treatment protocol, drug side effects, success rate, how to use drugs and their side effects Second session: how to donate gametes and Embryo, fertility storage, uterus rental, talking about sexual problems, identifying women's thoughts and centralized feelings about infertility by discussing group discussions and expressing their opinions and exercising relaxation 9. (1. Mind-to-Muscle Technique 2. Technique Muscle to mind) Session 3: Helping to adapt to conditions, stress and sexual performance, exercises of lawmaking with reflection of the mind The focus is on women's respiration, based on the BIRITISH protocol and relaxation practice. Fourth part: 10, the expression of women's rights and discussion of other roles of women in life and practice of relaxation. The fifth session: the summing up of past sessions and the way Stress control (advise on exercise, especially hiking, starting a new pastime, meditating, and eating a stress relieving diet) and relaxation exercises. The sessions will be validated by the faculty members of the midwifery department at the university.</i_keyword>
      <i_keyword>Control group: In the control group, no advice is given to individuals, and at the end of the workbook, the contents of the stress control methods are given to both groups (control and intervention).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: Before intervention, after intervention, one month after intervention. Method of measurement: Newton Infertility Stress Questionnaire.</prim_outcome>
      <prim_outcome>Gender Roll Attitude. Timepoint: Before intervention, after intervention, one month after intervention. Method of measurement: Homami`s Gender Role Questionnaire.</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>Vice-Chancellor for Research in Alborz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-19</approval_date>
        <contact_name>Vice-Chancellor for Research in Alborz University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research and Technology, Alborz University of Medical Sciences, above Taleghani Square, Taleghani Square, Karaj, Alborz, Iran karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
