<?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>IRCT20190530043770N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of infertile couple's skills promotion package on Management Sexual relationship</public_title>
      <acronym></acronym>
      <scientific_title>The effect of infertile couple's skills promotion package on Management Sexual relationship</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This experimental study is a randomized clinical trial with a control group. The statistical population consist of Iranian infertile couples with female infertility referred to Mahdieh Hospital Infertility Center affiliated to Shahid Beheshti University of Medical Sciences and Health Services. This study will perform on 72 Iranian infertile couples (36 infertile couples in the intervention group and 36 infertile couples in the control group). Sampling method will be by available sampling. The questionnaires were completed by the samples who will signed the written consent. Then a list of samples will be prepared, then by the table of random numbers, The intervention and control group will be determined, Randomization description: Randomization will be done by using random numbers in Excel software:      
First, in a column, the groups will be entered as B, A, below each other, because the number of samples in each group is 36, so 36 B, A, will be entered below each other. In the opposite column, random numbers will be generated by using the rand function. In the next step, by using the sort function, random numbers will be sorted from small to large or inverse, so the order of the groups, B, A, will be changed. By the new order, individuals Will be allocated to intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention includes 4 training sessions (duration of each session 90 minutes) for 2 consecutive weeks (2 sessions per week) for the intervention group. The educational content includes information about the anatomy of the reproductive system and the process of reproduction and sexual anatomy, sexual response, sexual cycle physiology, factors affecting sexual response, sexual disorders in four areas of sexual desire, arousal, orgasm, pain and treatment strategies.The statistical population consists of Iranian infertile couples with female infertility referred to Mahdieh Hospital Infertility Center  affiliated to Shahid Beheshti University of Medical Sciences and Health Services. After selecting the center and obtaining the necessary licenses, the researcher will introduce himself to the patients and explain the objectives of the research, mentioning the optional of the Participation and the confidentiality of information, and will proceed to available sampling. The questionnaires will be completed in a quiet environment and in a separate room by the samples who have signed the written consent. Then a list of samples wil be prepared and the intervention and control group will be determined by random number table. Intervention 2: Control group:Infertile women and their husbands in the control group will not receive any intervention by the researcher during the study.</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>niloofar alimanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr St., Niayesh Intersection, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>nalimanesh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zohre keshavarz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr St., Niayesh Intersection, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>keshavarzzohre57@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female infertility
at least 2 years of infertility history
Iranian nationality
age of 20 to 45 years
no known mental illness
Lack of consumption of psychological drugs
Having sexual activity
Having informed consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>the occurrence of stressful events (such as death of relatives, divorce ....)
pregnancy during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>N97</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention includes 4 training sessions (duration of each session 90 minutes) for 2 consecutive weeks (2 sessions per week) for the intervention group. The educational content includes information about the anatomy of the reproductive system and the process of reproduction and sexual anatomy, sexual response, sexual cycle physiology, factors affecting sexual response, sexual disorders in four areas of sexual desire, arousal, orgasm, pain and treatment strategies.The statistical population consists of Iranian infertile couples with female infertility referred to Mahdieh Hospital Infertility Center  affiliated to Shahid Beheshti University of Medical Sciences and Health Services. After selecting the center and obtaining the necessary licenses, the researcher will introduce himself to the patients and explain the objectives of the research, mentioning the optional of the Participation and the confidentiality of information, and will proceed to available sampling. The questionnaires will be completed in a quiet environment and in a separate room by the samples who have signed the written consent. Then a list of samples wil be prepared and the intervention and control group will be determined by random number table.</i_keyword>
      <i_keyword>Control group:Infertile women and their husbands in the control group will not receive any intervention by the researcher during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Female sexual function score. Timepoint: At the beginning of the study (before the intervention) - 6 weeks after the end of the intervention. Method of measurement: Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>International index of erectile function score. Timepoint: At the beginning of the study (before the intervention) - 6 weeks after the end of the intervention. Method of measurement: International index of erectile function (IIEF).</prim_outcome>
      <prim_outcome>Sexual satisfaction score. Timepoint: At the beginning of the study (before the intervention) - 6 weeks after the end of the intervention. Method of measurement: Larson Sexual Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Sexual compatibility score. Timepoint: At the beginning of the study (before the intervention) - 6 weeks after the end of the intervention. Method of measurement: Iranian Couples Sexual  compatibility 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>IR.SBMU.PHARMACY.REC.1398.119</sec_id>
        <issuing_authority>کمیته اخلاق در پژوهش دانشگاه علوم پزشکی شهید بهشتی</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-15</approval_date>
        <contact_name>Research Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Vali-e-Asr St., Niayesh Intersection, Opposite to Shahid Rajaei Heart Hospital, Niayesh Educational and Research Complex, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
