<?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>IRCT201106126777N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-08-14</date_registration>
      <primary_sponsor>School of Nursing and Midwifery, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Counseling on quality of marital and sexual satisfaction of infertile couples</public_title>
      <acronym></acronym>
      <scientific_title>Effect of counseling on marital and sexual satisfaction of infertile couples: A Randomized, Controlled, Trial (RCT) study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, counseling was performed through three sessions of 60-90 minutes duration and one week apart. Each session consisted of a lecture, discussion, questions and answers, and providing educational brochures and pamphlets. In the first session of intervention, definition of infertility, prevalence of infertility, etiologies, therapies and its impacts on various aspects of personal lives, particularly sexual and marital satisfaction, and their counteractive approaches were explained. The purpose of the session was providing general information about the infertility.&#13;
The second discussion dealt with behaviors that create marital satisfaction. The ultimate objective was to improve marital satisfaction through teaching communicative skills. These skills, including expression of feelings and emotions, resolving differences, forgiveness, mutual respect and supportive relationship of the couple, listening actively, expressing emotions, particularly about infertility and problem-solving skills such as ability to criticize and accept criticism and establishing a supportive relationship between the couple, were taught in this session.&#13;
The third session discussed the influencing factors and approaches for improving sexual satisfaction. The objective of this session was to improve sexual satisfaction through provision of necessary knowledge about male and female sexual cycles and issues such as self-esteem and self-confidence in sexual activities, and the quality and quantity of sexual intercourse. &#13;
We planned the counseling sessions, while couples in intervention group had to refer to the clinic for their scheduled medical appointment. So they did not need more visit for consultation meetings. Intervention 2: The control group only received the routine therapies and services of the fertility center. No counseling was included for this 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo Pakgohar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Sq, East Nosrat St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 140 2531</telephone>
        <email>mpakgohar@razi.tums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Pakgohar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Sq-east</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 912 140 2531</telephone>
        <email>mpakgohar@razi.tums.ac.ir</email>
        <affiliation>School of Nursing and Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: infertility for 1-10 years, having no children; no previous history of assisted reproductive technologies (ART);not suffering from known mental or physical diseases; not using drugs which affect sexual function and monogamy for men. &#13;
 Exclusion criteria: positive pregnancy test during sampling and follow-up and attending counseling sessions outside our center</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, counseling was performed through three sessions of 60-90 minutes duration and one week apart. Each session consisted of a lecture, discussion, questions and answers, and providing educational brochures and pamphlets. In the first session of intervention, definition of infertility, prevalence of infertility, etiologies, therapies and its impacts on various aspects of personal lives, particularly sexual and marital satisfaction, and their counteractive approaches were explained. The purpose of the session was providing general information about the infertility.&#13;
The second discussion dealt with behaviors that create marital satisfaction. The ultimate objective was to improve marital satisfaction through teaching communicative skills. These skills, including expression of feelings and emotions, resolving differences, forgiveness, mutual respect and supportive relationship of the couple, listening actively, expressing emotions, particularly about infertility and problem-solving skills such as ability to criticize and accept criticism and establishing a supportive relationship between the couple, were taught in this session.&#13;
The third session discussed the influencing factors and approaches for improving sexual satisfaction. The objective of this session was to improve sexual satisfaction through provision of necessary knowledge about male and female sexual cycles and issues such as self-esteem and self-confidence in sexual activities, and the quality and quantity of sexual intercourse. &#13;
We planned the counseling sessions, while couples in intervention group had to refer to the clinic for their scheduled medical appointment. So they did not need more visit for consultation meetings.</i_keyword>
      <i_keyword>The control group only received the routine therapies and services of the fertility center. No counseling was included for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Pre test, 3 month after intervention. Method of measurement: Sexual satisfaction questionnare.</prim_outcome>
      <prim_outcome>Marital satisfaction. Timepoint: Pre test, 3 month after intervention. Method of measurement: Marital satisfaction questionnare.</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>School of Nursing and Midwifery, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2006-12-26</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz blvd., Ghods st. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
