<?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>IRCT20210823052271N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-21</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of online men's reproductive health education before childbearing on knowledge, attitudes, and behaviors of preconception health in couples</public_title>
      <acronym></acronym>
      <scientific_title>The effect of online men's reproductive health education before childbearing on knowledge, attitudes, and behaviors of preconception health in couples</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>336</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Present intervention is the result of designing a men's reproductive health program before childbearing by the research team, Randomization description: Eligible couples will be randomly assigned into two groups using block randomization with a block size of 4 and an allocation ratio of 1:1. Thus, after listing all possible situations of 4 blocks and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into intervention and control groups. For allocation concealment, each couple will receive a code and all codes will be kept in an opaque envelope until the time of intervention. Sequencing of allocation and preparation of envelopes will be done by a person that will not involve in sampling and data collection. The researcher and the participant will not aware of the groups and the intervention that they received until the commencement of the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention will consist of four group education sessions (each group with 14 couples) and online on Skyroom.Three sessions of non-sexual content will be conducted by a reproductive health specialist (researcher), and one session of sexual content will be conducted by a general practitioner and a reproductive health specialist (for men and women, respectively).Session 1: Defining male reproductive health and individual and non-individual risk factors affecting reproductive health before childbirth - Reproductive lifestyle plan, Healthy lifestyle and nutritional recommendations before childbearing, the effect of parental age on fertility, and neonatal outcomes. Session 2: The effect of chronic diseases in men on reproductive health and drugs that have a negative effect on sperm and fertility. Session 3: The best time for intercourse for pregnancy and fertility chance in the month - sexually transmitted infections and their effect on reproductive and fetal health. Session 4: The physiological changes that occur during pregnancy and how to adapt to them. The content of the educational intervention was designed based on the needs of men (resulting from a qualitative study), the opinion of experts, and the most up-to-date studies in the field of men's preconception health. Intervention 2: Control group: will receive routine preconception education from health centers, and the researcher will not be involved.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data can be published after the accomplishment of the dissertation

When:
One year after completing the dissertation

To whom:
Bushehr and Shahroud University of Medical Sciences-  Academic researchers

Conditions:
Data will be available after publication in journals

Where to obtain:
zeinab rabiei, Email:zeinab.rabiei66@gmail.com

How to obtain:
The information will be available through the publication of the article. But if more information is needed, the request should be sent via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Motaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Reproductive Health, School of Medicine, Shahroud University of Medical Sciences, Haft Tir Square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73943</zip>
        <telephone>+98 23 3239 3962</telephone>
        <email>zmotaghi8@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Rabiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Haft Tir Square</address>
        <city>ُShahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773943</zip>
        <telephone>+98 23 3239 3962</telephone>
        <email>zeinab.rabiei66@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian
Literacy for reading and writing
َAge 15-50 years old for men and 18-45 years old for women
Intend to have children
Have the consent and cooperation to participate in the study</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue collaboration at any stage of research
Employees and students of the University of Medical Sciences
Having a history of infertility treatment
Having a known chronic disease
Spouse being pregnant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention will consist of four group education sessions (each group with 14 couples) and online on Skyroom.Three sessions of non-sexual content will be conducted by a reproductive health specialist (researcher), and one session of sexual content will be conducted by a general practitioner and a reproductive health specialist (for men and women, respectively).Session 1: Defining male reproductive health and individual and non-individual risk factors affecting reproductive health before childbirth - Reproductive lifestyle plan, Healthy lifestyle and nutritional recommendations before childbearing, the effect of parental age on fertility, and neonatal outcomes. Session 2: The effect of chronic diseases in men on reproductive health and drugs that have a negative effect on sperm and fertility. Session 3: The best time for intercourse for pregnancy and fertility chance in the month - sexually transmitted infections and their effect on reproductive and fetal health. Session 4: The physiological changes that occur during pregnancy and how to adapt to them. The content of the educational intervention was designed based on the needs of men (resulting from a qualitative study), the opinion of experts, and the most up-to-date studies in the field of men's preconception health.</i_keyword>
      <i_keyword>Control group: will receive routine preconception education from health centers, and the researcher will not be involved.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Men's preconception health knowledge. Timepoint: Before, end and 2 months after intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Attitude to men's preconception health. Timepoint: Before, end and 2 months after intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Healthy behaviors before having children. Timepoint: Before, and 2 months after intervention. Method of measurement: Researcher made questionnaire.</sec_outcome>
      <sec_outcome>Satisfaction with preconception education. Timepoint: ٍEnd of  the intervention. Method of measurement: Researcher made 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-08</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Haft Tir Square, Tehran Ave. Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
