<?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>IRCT20240507061694N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-02</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of evening primrose oil with misoprostol on cervical preparation before hysteroscopy and dilation and curettage</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of evening primrose oil and misoprostol on cervical preparation before hysteroscopy and dilation and curettage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91255</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Due to ease of use and saving time, the participants were divided into two groups using random sequence generation software. In this way, information such as the sample size and the number of groups is given to the software (Random allocation software) and the software provides a table of random numbers in which the letters A and B are randomly assigned to each number. In this study, numbers with letter A are in the intervention and numbers with letter B are in the control group, Blinding description: This study is a double-blind clinical trial in which the participant, the outcome assessor and the data analyst will be unaware of the treatment process. After randomization, the patients of each treatment group are introduced by researcher 1 (orology resident) to researcher 2 to evaluate the outcome. Researcher 2 ( the supervisor) is only an outcome assessor and records the results without knowing the type of treatment and its effects. A person who is an information analyst (statistician) also receives the recorded information at the end of the work and is not in the process of the intervention groups in any way. Drug injection will be done by an anesthesiologist. In each of the groups, the desired drugs is placed in the posterior fornix of the vagina by the resident 6 hours before hysteroscopy. The surgeon and the patients will not know the type of drug used, and before the surgeon enters, the removal of the probe and the drape will be done by another person, and if there is a vaginal pill, the pill will be removed so that the surgeon does not notice the presence of the vaginal pill and its type.Patients also do not know about the injectable substance.</study_design>
      <phase>2</phase>
      <hc_freetext>Hysteroscopy and dilation and curettage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In patients of this group, 1capsules of 100 mg evening primrose oil ( Abidi Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 hours before hysteroscopy. Intervention 2: Control group: Control group: In patients of this group, Suppository of 400 micrograms of misoprostol (Samisaz Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 hours before hysteroscopy.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maedeh Hakimipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrdari Street, 15th Khordad Square, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8713783976</zip>
        <telephone>+98 31 5544 3022</telephone>
        <email>m_hakimipoor@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansoureh Samimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrdari Street, 15th Khordad Square, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8713783976</zip>
        <telephone>+98 31 5544 3022</telephone>
        <email>msamimi@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 18-75 are candidates for hysteroscopy and dilation and curettage.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Current pregnancy
Cervical or vaginal infections
Contraindications for misoprostol and EPO
Cervical abnormalities and insufficiency
Previous Müllerian type birth</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In patients of this group, 1capsules of 100 mg evening primrose oil ( Abidi Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 hours before hysteroscopy</i_keyword>
      <i_keyword>Control group: Control group: In patients of this group, Suppository of 400 micrograms of misoprostol (Samisaz Pharmaceutical Company) are placed in the posterior fornix of the vagina by the resident, 6 hours before hysteroscopy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The time to reach the required dilatation (4 to 8 mm). Timepoint: From the start of the operation until reaching the required expansion. Method of measurement: Clinical.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cervical rupture. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations.</sec_outcome>
      <sec_outcome>Perforation of the uterus. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations.</sec_outcome>
      <sec_outcome>Side effects. Timepoint: Immediately after the patient regains consciousness. Method of measurement: Clinical observations.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-07</approval_date>
        <contact_name>Working Group/Research Ethics Committees, Faculty of Medicine and Faculty of Dentistry, Kashan Unive</contact_name>
        <contact_address>Shahrdari Street, 15th Khordad Square, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
