<?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>IRCT2015042721955N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-02</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>A Comparison psycho-sexual therapy and pharmacotherapy Bupropion interventions on improvement of sexual function in infertile women</public_title>
      <acronym>-</acronym>
      <scientific_title>A Comparison of the effect psycho-sexual therapy and pharmacotherapy Bupropion interventions on improvement of sexual function in infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sexual Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Psycho-sexual therapy group: This group will participate in a two-hour group session for 10 weeks. Each group consists of 8–12 members. Therapeutic model is a combination of mind fullness-Based cognitive therapy and sexual skills. Sexual behavioral program is based on Crowe and Ridley model. Intervention 2: Pharmacotherapy group: This group will take a tablet of Bupropion SR (150 mg) daily (evening) (manufactured by D Abidi plant) for two months by a psychiatrist. Subjects will receive 30 tablets after the interview, and will refer to center monthly to receive their medication. Duration of treatment will be two months. Intervention 3: Control group: Participants in this group will complete questionnaires at the beginning of the study and two months afterward. In order to observe the ethics of research, members of this group will be referred to sex therapy clinic at the end of two months of treatment. All groups will complete questionnaires in the beginning and ending of 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hajar Pasha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Midwifery Department, Babol University of Medical Sciences, Ganjafrouze Street, Mazandaran Province, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>h.pasha@mubabol.ac.ir;  pashahajar@yahoo.com;  dhajarpasha@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Basirat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol  University of Medical Sciences, Tork Mahalleh, Babol, Mazandaran province, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 0597</telephone>
        <email>basiratzahra@yahoo.com</email>
        <affiliation>Fatemeh Alzahra Infertility and Reproductive Health Research Center of the Babol University of Medic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included: The less or equal score of 26.55 from Female Sexual Function Index(FSFI); The final diagnosis with clinical interview is based on DSM-V criteria by psychologist; duration of infertility more than 1 year; women infertile who did not decide to undergo fertility treatment until 2 months afterward; aged between 15-45 years; ability to read and to write; having a stable sexual activity(at least for recent four weeks); availability of the husband; no remarrying of couples; no history of sterilization; no foster child. Exclusion criteria included: drug abuse; severe psychiatric disorders(major depression, bipolar disorder, patients with suicidal idea or psychosis); history of physical illness(diabetes mellitus, cardiovascular diseases, hypertension, hyperthyroidism, hypothyroidism, epilepsy, hepatic dysfunction); physical problems(spinal cord injury, limb deformity); mental health problems under the treatment of a physician; drugs consumers causing sexual dysfunction such as barbiturates, benzodiazepines , antidepressants, ant hypertensions; having psychological support( psychotherapy sessions, relaxation techniques, yoga ); experiencing a stressful event in the past three months(death or serious illness in the family, a major change in living conditions).</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction, not caused by organic disorder or disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Psycho-sexual therapy group: This group will participate in a two-hour group session for 10 weeks. Each group consists of 8–12 members. Therapeutic model is a combination of mind fullness-Based cognitive therapy and sexual skills. Sexual behavioral program is based on Crowe and Ridley model.</i_keyword>
      <i_keyword>Pharmacotherapy group: This group will take a tablet of Bupropion SR (150 mg) daily (evening) (manufactured by D Abidi plant) for two months by a psychiatrist. Subjects will receive 30 tablets after the interview, and will refer to center monthly to receive their medication. Duration of treatment will be two months.</i_keyword>
      <i_keyword>Control group: Participants in this group will complete questionnaires at the beginning of the study and two months afterward. In order to observe the ethics of research, members of this group will be referred to sex therapy clinic at the end of two months of treatment. All groups will complete questionnaires in the beginning and ending of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function. Timepoint: Before and two months after of intervention. Method of measurement: Female Sexual Function Index (FSFI), and clinical interview based on the diagnostic criteria of DSM-V.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression, Anxiety, General health, Sleep Quality, Couple Burnout, Body Image. Timepoint: Before and two months after of intervention. Method of measurement: Beck Depression Inventory (BDI), Spielberger State-Trait Anxiety Inventory (STAI), General health questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI), Couple Burnout Measurement (CBM), and Body Image Assessment, and clinical interview based on the diagnostic criteria of DSM-V.</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>2014-12-10</approval_date>
        <contact_name>The Ethics Committee of  Babol University of  Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganjafrouze Street, Mazandaran Province, Iran Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
