<?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>IRCT20180417039338N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-26</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Nifedipine on Pregnancy Rates in ICSI cycles</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Nifedipine Administration Before Embryo Transfer on Pregnancy Rates in ICSI cycles, a double blind control trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32902</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The medicine contains 100 pills of nifedipine 10 mg (Tolidaru co.) from the package and both are placed in a uni-shape capsule by data collector. As well as 100 pills of folic acid (Iran Drug Pharmacy), 1mg will also be placed in uni-color capsules. The capsules are then inserted into a small uni-shape zipped bag and placed in the uni- shape pocket according to the code. Then the code list will extinct, Randomization description: All blocking and random allocation processes are performed by the University's statistics center. The statistician uses the online randomization method and the online Randomization.com site for random block assignment. Ultimately, patients are assigned through methods in two groups according to randomized block-sized numbers with block-8, Blinding description: According to the randomized block list, which is given to the mentioned midwife from the university's statistics center, the prescription of the encoded uni- shape pills is done by her. In the end, the list of demographic characteristics and pregnancy outcomes are collected and recorded by the outcome assessor. Patients, the endometrial monitor responsible, the embryo transfer physician, the ICSI laboratory staff and the outcome assessor are not aware of the patient's allocation. The list is inserted in SPSS  by statistics.</study_design>
      <phase>3</phase>
      <hc_freetext>Recurrent Implantation failure in IVF.</hc_freetext>
      <i_freetext>Intervention group: Intervention group are received Nifedipine Tablet 20 mg  for 1/2 hr before embryo transfer.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol- Amol old road</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47135-547</zip>
        <telephone>+98 11 3227 4882</telephone>
        <email>m.golsorkhtabar@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol- Amol old road</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47135-547</zip>
        <telephone>+98 11 3227 4882</telephone>
        <email>basiratzahra@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.Women 18-40 yr with BMI&lt;38 undergo ICSI treatment and freeze embryo transfer candidate are participated in this study.2. Blood pressure &gt;= 100/60, 3. FSH &lt;14mli/IU. 4. abnormal uterus in HSG or hystroscopy. 5.  who do not contraindicate the use of nifedipine, such as heart and liver 6. Patients who do not have a history of irregular heart rate or who do not use hypotention medication.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients who have been taking medication with nifedipine over a month have interfered with drugs such as benzodiazepines, flecainide, imipramine, propafenone, azole antifungals, cimetidine, cyclosporine, erythromycin, quinidine, terfenadine, warfarin and theophylline. 2.Those who have blood pressure of 60/100 (mmHg) or less before embryo transfer</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group are received Nifedipine Tablet 20 mg  for 1/2 hr before embryo transfer</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy rate( hCG&gt;31IU/LI) 12 days following embryo transfer. Timepoint: 12 days following embryo transfer. Method of measurement: Blood test, BHCG.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Implantation rate: Gestational sac. Timepoint: in 6 weeks after pregnancy. Method of measurement: vaginal sonography.</sec_outcome>
      <sec_outcome>Clinical pregnancy, Fetal heart rate observation. Timepoint: 6-8 after pregnancy. Method of measurement: vaginal sonography.</sec_outcome>
      <sec_outcome>Spontaneous abortion. Timepoint: before 20 week pregnancy. Method of measurement: vaginal sonography.</sec_outcome>
      <sec_outcome>Complications of pregnancy and infant including multiple or ectopic pregnancy, spotting and vaginal bleeding. Timepoint: in 3 months pregnancy. Method of measurement: vaginal sonography.</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>2018-08-01</approval_date>
        <contact_name>BaboL university of Medical Science</contact_name>
        <contact_address>Ghanj afrouz ST. Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
