<?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>IRCT20180811040762N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-11</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques</public_title>
      <acronym></acronym>
      <scientific_title>The effect of infertility coach program on the level of percieved stress and treatment outcome of women under the treatment of assisted reproductive techniques</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33357</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the current randomized intervention,two groups with 30 patients are allocated in intervention and control groups Devided  between groups will be done through random method ,in other word 60 envelopes are considered and intervention and control  groups are defined with a and b letter. This envelopes will be assigned to any  included indiviuals of study randomely and ultimately, patients will be taken in  to the intervention and  control groups. This calculation was performed through the G-power  software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: اntervention group: 1. description of genital anatomy, reproductive hormones,Also  how the effect of stress and negative emotions on  hormonal and physiological changes in the reproductive system  Explanation of the stages of treatment with IVF.The Second session on days 19 to 20 of Cycle: Before the visit,the responding to  possible questions  of patient,Speak regarding the improvement of the negative emotions control Attendance at a visit,Answer to the  possible patient questions of the after completing the visit,On day2of the next cycle (approximately 10 days after the second session): counseling on  improving communication skills,Setting  predeterminead  questions using a patient's possible  worries,Attendance at a visit,After visiting about the  with the  counseling  of medications,The fourth session on 6-8th cycle (about one week after the third meeting): Stress reduction and effective coping strategies methods.Attendance at a visit,Fifth session on removal oocyte day and around day 14: A brief explanation about oocyte   oocyte removal operation ,Answer to the  possible patient questions of the after completing the visit,Transfering  day: A brief description about  the transfer operation,Answer to the  possible patient questions of the after completing the visit,. Intervention 2: Control group: Routine 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zeinab HamzehGardesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street  Sari  Mazandaran  Iran, Islamic Republic Of</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4843163181</zip>
        <telephone>+98 48 4316 3181</telephone>
        <email>z.hamzehgardeshi@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zeinab HamzehGardeshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh Nursing and Midwifery Faculty, Vesal Street, Amir Mazandarani Street  Sari  Mazandaran , Iran</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48431-63181</zip>
        <telephone>+98 11 3379 5550</telephone>
        <email>hamzehgardeshi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women less than 45 years
Primary infertility
Women treated with IVF and ICSI (maximum 3 times)
Iranian nationality
Having reading and writing ability</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use no Cigarette, hookah and drink alcohol
having systemic diseases such as diabetes, hypertension, hyperlipidemia and thyroid gland disease based on the treatment history, information of records and reports of the research unit
under consulting of psychologist or psychiatrist during the study or at least one month before the start of the study
Have major psychiatric disorder during the study period (diagnose by primary visit by psychiatrist) and consumption no psychiatric drugs
Have  adopted child
Do intend to use the embryo and oocyte donation or a rented uterus</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>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>اntervention group: 1. description of genital anatomy, reproductive hormones,Also  how the effect of stress and negative emotions on  hormonal and physiological changes in the reproductive system  Explanation of the stages of treatment with IVF.The Second session on days 19 to 20 of Cycle: Before the visit,the responding to  possible questions  of patient,Speak regarding the improvement of the negative emotions control Attendance at a visit,Answer to the  possible patient questions of the after completing the visit,On day2of the next cycle (approximately 10 days after the second session): counseling on  improving communication skills,Setting  predeterminead  questions using a patient's possible  worries,Attendance at a visit,After visiting about the  with the  counseling  of medications,The fourth session on 6-8th cycle (about one week after the third meeting): Stress reduction and effective coping strategies methods.Attendance at a visit,Fifth session on removal oocyte day and around day 14: A brief explanation about oocyte   oocyte removal operation ,Answer to the  possible patient questions of the after completing the visit,Transfering  day: A brief description about  the transfer operation,Answer to the  possible patient questions of the after completing the visit,</i_keyword>
      <i_keyword>Control group: Routine center care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress related to infertility. Timepoint: Before the intervention, puncture day, day of embryo transfer, day of pregnancy test. Method of measurement: Newton Infertility Stress Questionnaire.</prim_outcome>
      <prim_outcome>The outcome of assisted reproduction treatment. Timepoint: Two weeks after embryo transfer. Method of measurement: By using Beta-HCG measurement by blood tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The number of oocytes obtained. Timepoint: Immediately after intervention. Method of measurement: View by embryologists.</sec_outcome>
      <sec_outcome>The fertilization rate. Timepoint: 5 after the intervention. Method of measurement: View by embryologists.</sec_outcome>
      <sec_outcome>Pregnancy outcome. Timepoint: Three weeks after the intervention. Method of measurement: Beta-HCG measurement by blood tests.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-11</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical science</contact_name>
        <contact_address>Moalem Street, Vice chancellor for research  Sari  MazandaranIslamic Republic Of Iran sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
