<?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>IRCT20201005048925N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-12</date_registration>
      <primary_sponsor>National Institue for Medical Research Development (NIMAD)</primary_sponsor>
      <public_title>Effectiveness of an educational intervention on fertility knowledge, childbearing intention and planned pregnancy among new couples</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of an educational intervention on fertility knowledge, childbearing intention and planned pregnancy among new couples referring to premarital counselling centers: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51413</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples will be selected through stratified sampling and random samples are then selected from each stratum. The strata consist of 5 cities and separate randomization lists will be prepared for each city using a block randomization. 
Then we will use central randomization that is stratified to the cities. 
The couples will randomly be assigned into 2 groups in each city by a computer-generated random sequence. 
For randomization, the permuted block randomization will be used (block size=4). According to the sample size of 440 identified, 110 blocks will be produced using the online site (www.sealedenvelope. com) for Tehran.
According to the sample size of 200 identified, 50 blocks will be produced using the online site (www.sealedenvelope. com) for other cities.
Allocation will be concealed by using sequentially numbered opaque sealed envelopes that contain group assignments determined by computer-generated random sequences, Blinding description: Given the nature of the intervention, it is not possible to blind participants to researchers involved in providing the intervention and data collection. However, allocation to intervention or control groups will be blinded for researchers in the data set available during data analysis. 
To avoid the potential contamination between two groups, we will provide the educational intervention after the typical premarital counselling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fertility knowledge. Condition 2: Childbearing intention. Condition 3: Planned pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing virtual (off-line) educational package at two time episodes with an interval of one month. The intervention includes text messages and short films. The content of educational or counselling program will be based on the most updated literature on fertility knowledge. The fertility knowledge package will consist of information on fertility rates, infertility rates, risks of delay in childbearing, safe waiting period for parenting, Impact of age on female fertility, limited fertility period for women, fertility window and how to optimize fertility, impact of weight and lifestyle on fertility, definition of infertility, infertility risk factors, impact of STD on fertility, the need for earlier evaluation and treatment of infertility, success rate and financial costs of infertility treatments, assisted conception and fertility preservation. Intervention 2: Control group: The control group will receive only typical premarital counselling in public health centers.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vanak, Rashid Yasemi</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19395-4798</zip>
        <telephone>+98 21 8867 1613</telephone>
        <email>ranjbar.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Ranjbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi St., Valiasr Ave.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19395-4798</zip>
        <telephone>0098218671613</telephone>
        <email>ranjbar.f@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Childless couples are about to live together in their new home (under one roof) in the near future
having an Iranian nationality
Minimum basic literacy
Aging from 18 to 35 years, men aging 18-45
Lacking prior marriage history</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Medical students or staff
Having any known chronic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive both the typical premarital counselling training and a fertility knowledge package containing virtual (off-line) educational package at two time episodes with an interval of one month. The intervention includes text messages and short films. The content of educational or counselling program will be based on the most updated literature on fertility knowledge. The fertility knowledge package will consist of information on fertility rates, infertility rates, risks of delay in childbearing, safe waiting period for parenting, Impact of age on female fertility, limited fertility period for women, fertility window and how to optimize fertility, impact of weight and lifestyle on fertility, definition of infertility, infertility risk factors, impact of STD on fertility, the need for earlier evaluation and treatment of infertility, success rate and financial costs of infertility treatments, assisted conception and fertility preservation.</i_keyword>
      <i_keyword>Control group: The control group will receive only typical premarital counselling in public health centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fertility knowledge. Timepoint: Data will be collected by at baseline and 3, 12 and 18 months after the intervention. Method of measurement: Cardiff Fertility Knowledge Scale (CFKS).</prim_outcome>
      <prim_outcome>Childbearing intention. Timepoint: Data will be collected by at baseline and 3, 12 and 18 months after the intervention. Method of measurement: The childbearing intention questionnaire.</prim_outcome>
      <prim_outcome>Planned pregnancy (positive pregnancy test). Timepoint: Data will be collected by at baseline and 3, 12 and 18 months after the intervention. Method of measurement: Demographic and fertility characteristics questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Contraception method. Timepoint: Baseline, 3, 12 and 18 month after intervention. Method of measurement: Demographic and reproductive characteristic questionnaire.</sec_outcome>
      <sec_outcome>Miscarriage. Timepoint: Baseline, 3, 12 and 18 month after intervention. Method of measurement: Demographic and reproductive characteristic questionnaire.</sec_outcome>
      <sec_outcome>Unplanned pregnancy. Timepoint: Baseline, 3, 12 and 18 month after intervention. Method of measurement: Demographic and reproductive characteristic questionnaire.</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>National Institue for Medical Research Development (NIMAD)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-09</approval_date>
        <contact_name>National Institute for Medical Research Development (NIMAD)</contact_name>
        <contact_address>No.21, Besat Ave., West Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
