<?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>IRCT20161230031662N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-05</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect childbearing counseling By Midwife on fertility intention among New couple</public_title>
      <acronym></acronym>
      <scientific_title>The effect of midwifery-Led childbearing counseling on fertility knowledge; desire and intention among New couple</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65979</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks.
Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 112 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All couples eligible to enter the study will complete the personal profile form, fertility and fertility knowledge if they agree to participate in the initial study. Both groups will intervene and control the center's routine counseling services. Then a 60-minute intervention session of childbearing counseling in the form of a speech and group discussion will be held online for groups of 14 people in the intervention group (women and men in the sessions they want to be). Except for one session in the Sky Room, the rest of the sessions will be conducted as a (private) couple counseling on the appropriate virtual messenger network. Virtualization by phone, SMS;Text file, audio, online meetings (Skyroom) will be designed and implemented through suitable platforms and messaging systems. The time of the meetings will be adjusted with the coordination of the participants so that the maximum participation is held with the least obstacles. A meeting may be held in the morning and the next meeting in the evening. The participant's phone, email address and phone number connected to the virtual network will be collected from him to enable the exchange of information, interaction (participants are asked to view and study the contents) to inform the researcher to record in a sheet), complete the questionnaires and send the contents as well as the necessary reminders. Educational and advisory content about fertility knowledge will be compiled by the research team based on the guidelines of the Ministry of Health and the reliable sources and sites. After the end of the intervention, both groups will complete the questionnaires online again after one month. After the end of the intervention and completion of the questionnaires, a session of sex education and parenting in the form of a podcast and text file will be held for the control group. Contents in the field of anatomy and physiology in brief, the rate of fertility and infertility, the risks of delay in fertility, the safe time to wait until childbearing, the effect of age on women's fertility, the definition of infertility and the factors affecting infertility, the benefits of childbearing and its impact on health. family), fertility time during the monthly cycle, the impact of various and important factors in pregnancy such as obesity and smoking, sexually transmitted infections and information on infertility treatments and costs, etc. Intervention 2: Control group:56 number of  control group will receive only routine counseling.</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:
Total potential data can be shared after unidentifiable people.

When:
Date will be in access 6 months after publishing the results.

To whom:
only for researchers working in academic and scientific institution.

Conditions:
scientific studies

Where to obtain:
using Email address:poonehrad73@gmail.com

How to obtain:
up to a week after sending the Email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shamsolmolok Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>768534192698+</telephone>
        <email>Poonehrad73@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Lotfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nobovvat Square, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 26 3441 5351</telephone>
        <email>Lotfi_razieh@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian men and women able to speak Farsi.
Be literate in reading and writing
Aged 18 to 39 for women and 18 to 49 for men
Without previous marriage
Cohabitation with one month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The personnel of the medical department
Couples who have not lived together after one month for any reason
Chronic physical and severe mental illnesses</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: All couples eligible to enter the study will complete the personal profile form, fertility and fertility knowledge if they agree to participate in the initial study. Both groups will intervene and control the center's routine counseling services. Then a 60-minute intervention session of childbearing counseling in the form of a speech and group discussion will be held online for groups of 14 people in the intervention group (women and men in the sessions they want to be). Except for one session in the Sky Room, the rest of the sessions will be conducted as a (private) couple counseling on the appropriate virtual messenger network. Virtualization by phone, SMS;Text file, audio, online meetings (Skyroom) will be designed and implemented through suitable platforms and messaging systems. The time of the meetings will be adjusted with the coordination of the participants so that the maximum participation is held with the least obstacles. A meeting may be held in the morning and the next meeting in the evening. The participant's phone, email address and phone number connected to the virtual network will be collected from him to enable the exchange of information, interaction (participants are asked to view and study the contents) to inform the researcher to record in a sheet), complete the questionnaires and send the contents as well as the necessary reminders. Educational and advisory content about fertility knowledge will be compiled by the research team based on the guidelines of the Ministry of Health and the reliable sources and sites. After the end of the intervention, both groups will complete the questionnaires online again after one month. After the end of the intervention and completion of the questionnaires, a session of sex education and parenting in the form of a podcast and text file will be held for the control group. Contents in the field of anatomy and physiology in brief, the rate of fertility and infertility, the risks of delay in fertility, the safe time to wait until childbearing, the effect of age on women's fertility, the definition of infertility and the factors affecting infertility, the benefits of childbearing and its impact on health. family), fertility time during the monthly cycle, the impact of various and important factors in pregnancy such as obesity and smoking, sexually transmitted infections and information on infertility treatments and costs, etc.</i_keyword>
      <i_keyword>Control group:56 number of  control group will receive only routine counseling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average fertility knowledge score in the Cardiff questionnaire. Timepoint: Before the start of the study and 4 weeks after the end of the intervention. Method of measurement: The Cardiff Psychometric Fertility Knowledge Questionnaire.</prim_outcome>
      <prim_outcome>The mean fertility tendency score in the questionnaire of Naghibi et al. Timepoint: Before the start of the study and 4 weeks after the end of the intervention. Method of measurement: Fertility Desire Questionnaire, designed by Naghibi et al. (2019).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The average time of intention to have the first child, in a question designed by the researcher. Timepoint: Before the start of the study and 4 weeks after the end of the intervention. Method of measurement: With a question designed by the researcher, the period of time (months) when they decide to have their first child after marriage is determined.</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-26</approval_date>
        <contact_name>Ethics Committee of Alborz university of medical sciences</contact_name>
        <contact_address>Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
