<?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>IRCT2012061710048N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-20</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of cognitive behavioral therapy and pharmacotherapy on infertility stress</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of cognitive behavioral therapy and pharmacotherapy on infertility stress: A randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2007-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>89</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10535</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility stress.</hc_freetext>
      <i_freetext>Intervention 1: Participants in the CBT group were engaged in a 10-week, two-hour group cognitive behavior therapy program. Progressive muscle relaxation was added to sessions 5–10. Groups consisted of 8–12 members and the therapist was an expert psychologist who trained for the CBT program. Therapy was conducted at the Psychiatry Department of the Babol University of Medical Sciences. The first three sessions provided patients with a general orientation to cognitive therapy and the causes of infertility. A gynecologist participated in the first three sessions for 30 minutes and explained the cause of infertility for each patient.Cognitive interventions have been based on the premise that both negative automatic thoughts and dysfunctional attitudes to social concerns, sexual concerns, marital concerns, rejection of childfree lifestyle, and need for parenthood more require restructure. The following three sessions (sessions 4–6) included the identification and challenging of core dysfunctional or irrational beliefs that underlie automatic negative thoughts about the infertility. Finally, sessions 7–10 taught participants varying techniques (e.g. countering, self-reward) for maintaining the change of their dysfunctional beliefs about infertility. In addition to the above program, sessions 5–10 taught participants progressive muscle relaxation in a group setting. For home practicing, subjects read a relaxation book and listened to a 20-minute pre-recorded CD two times daily over a period of 5 weeks. Cognitive sessions were conducted based on Beck Depression Inventory and tension releasing sessions were conducted based on Relaxation Inventory of Jacobson. Intervention 2: The pharmacotherapy group took a capsule of fluoxetine (20 mg) daily for 90 days. After the interview, the subjects took 30 capsules from the midwives of the center and return monthly to get their drug. Intervention 3: The control group didn’t undergo any drug or psychological intervention. They completed two questionnaires at the beginning of the study and 3 months after the interview.</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 Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 1329 4456</telephone>
        <email>mahbob330@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hajar Pasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>در قسمت اسپانسر نام خود را مرقوم نفرمایید. لطفا نام و مشخصات و آدرس و تلفن معاون پژوهشی موسسه ای که بودجه تحقیق را فراهم کرده یا دانشگاهی که تحقیق در آن اتفاق افتاده است را وارد کنید.</address>
        <city>babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 12 1327 0576</telephone>
        <email>h.pasha@mubabol.ic.ir; hajarpasha@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with these characteristics were invited to this study: age younger than 45 years old; education more than five years; infertility more than two years, having at least one IVF; not undergoing fertility treatment until 3 months afterward; not currently practicing any relaxation techniques; not participating in any support group; not currently taking any psychotherapy; not currently undergoing any assisted reproductive therapy.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40-48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neurotic, stress-related and somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Participants in the CBT group were engaged in a 10-week, two-hour group cognitive behavior therapy program. Progressive muscle relaxation was added to sessions 5–10. Groups consisted of 8–12 members and the therapist was an expert psychologist who trained for the CBT program. Therapy was conducted at the Psychiatry Department of the Babol University of Medical Sciences. The first three sessions provided patients with a general orientation to cognitive therapy and the causes of infertility. A gynecologist participated in the first three sessions for 30 minutes and explained the cause of infertility for each patient.Cognitive interventions have been based on the premise that both negative automatic thoughts and dysfunctional attitudes to social concerns, sexual concerns, marital concerns, rejection of childfree lifestyle, and need for parenthood more require restructure. The following three sessions (sessions 4–6) included the identification and challenging of core dysfunctional or irrational beliefs that underlie automatic negative thoughts about the infertility. Finally, sessions 7–10 taught participants varying techniques (e.g. countering, self-reward) for maintaining the change of their dysfunctional beliefs about infertility. In addition to the above program, sessions 5–10 taught participants progressive muscle relaxation in a group setting. For home practicing, subjects read a relaxation book and listened to a 20-minute pre-recorded CD two times daily over a period of 5 weeks. Cognitive sessions were conducted based on Beck Depression Inventory and tension releasing sessions were conducted based on Relaxation Inventory of Jacobson.</i_keyword>
      <i_keyword>The pharmacotherapy group took a capsule of fluoxetine (20 mg) daily for 90 days. After the interview, the subjects took 30 capsules from the midwives of the center and return monthly to get their drug</i_keyword>
      <i_keyword>The control group didn’t undergo any drug or psychological intervention. They completed two questionnaires at the beginning of the study and 3 months after the interview</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of fertility problem in infertile women(fertility stress Inventory), depression before intervention. Timepoint: Before intervention. Method of measurement: Infertility Stress Inventory, Beck Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation of fertility problem in infertile women(fertility stress) , depression after intervention. Timepoint: 3 month after intervention. Method of measurement: Infertility Stress Inventory ,Beck Depression Inventory.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-02-24</approval_date>
        <contact_name>Babol University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Babol University of Medical Sciences Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
