<?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>IRCT201110267915N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-07-25</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of collaborative counseling on psychological subsequent in infertile women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of collaborative infertility counseling on perceived stress and coping strategies in infertile women undergoing IVF</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8359</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Primary Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Women in intervention group were counseled individually in 5 meetings with the participation of  MSc in midwife, gynecologist and MSc in clinical psychologist. Intervention  lasted almost 2 months (the time it take to complete a cycle of In Vitro Fertilization). The time of meeting was arranged as follow without incurring additional visit to subjects: 1. It was conducted by researchers on days 2 and 3  of cycle. 2. Around days 19 to 20 cycle that (after the sonography) was provided by psychologist and midwife. 3. The second day of the next cycle (approximately 10 days after the second session) and was conducted by psychologist and midwife. 4. 6-8 days of cycle (approximately one week after the third session)  that was held by the midwife. 5. were conducted by gynecologist at 14 day of cycle. Intervention 2: Control group received standard  center care.</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>Mahbobeh Rasolzadeh Bidboly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, Nursing Midwifery Faculty, Kashan University of Medical Sciences, Qotbe Ravandi Blvd, Kashan, Iran</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 2125</telephone>
        <email>Rasolzadeh-ma@kaums.ac.ir, Mehr232007@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences.Kashan.I.R.Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahbobeh Rasolzadeh Bidgoly</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Midwifery, Nursing Midwifery Faculty, Kashan University of Medical Sciences, Qotbe Ravandi Blvd, kashan, Iran</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 315554002125</telephone>
        <email>Mehr232007@yahoo.com; Rasolzadeh-ma@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  persian ethnicity; 20-45 aged;  literate; have primary infertility;  no recipient of donated  oocyte  or gestational carrier, no have adapted child; no smoker, drug and alcohol abuser; not have somatic or psychiatric problems; in basic sonogram ovaries was normal for beginning of treatment&#13;
Exclusion criteria: not responding to treatment;  not completing the treatment period for any reason; did not participate in counseling sessions regularly and did not done assignment</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Women in intervention group were counseled individually in 5 meetings with the participation of  MSc in midwife, gynecologist and MSc in clinical psychologist. Intervention  lasted almost 2 months (the time it take to complete a cycle of In Vitro Fertilization). The time of meeting was arranged as follow without incurring additional visit to subjects: 1. It was conducted by researchers on days 2 and 3  of cycle. 2. Around days 19 to 20 cycle that (after the sonography) was provided by psychologist and midwife. 3. The second day of the next cycle (approximately 10 days after the second session) and was conducted by psychologist and midwife. 4. 6-8 days of cycle (approximately one week after the third session)  that was held by the midwife. 5. were conducted by gynecologist at 14 day of cycle.</i_keyword>
      <i_keyword>Control group received standard  center care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infertility persieved stress. Timepoint: Pretest (beginning of cycle) and posttest (after embryo transfer). Method of measurement: Fertility Problem Inventory.</prim_outcome>
      <prim_outcome>Coping strategies. Timepoint: Pretest (beginning of cycle) and posttest (after embryo transfer). Method of measurement: Ways of Coping Scale- Revised (WOC-R).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Marital Satisfaction. Timepoint: Pretest (beginning of cycle) and posttest (after embryo transfer). Method of measurement: Index of Marital Satisfaction.</sec_outcome>
      <sec_outcome>General Health. Timepoint: Pretest and posttest. Method of measurement: General Health Questionnaire-28.</sec_outcome>
      <sec_outcome>Treatment success. Timepoint: posttest. Method of measurement: Pregnancy 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-07-21</approval_date>
        <contact_name>Mashhad University of Medical Scienses</contact_name>
        <contact_address>Ghorashy building, Daneshgah street, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
