<?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>IRCT20250527065938N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-20</date_registration>
      <primary_sponsor>No. 971941913114، Yakhchal Street، Dr. Shariati Street, Tehran, Iran.</primary_sponsor>
      <public_title>Assessment of Tacrolimus Efficacy in Patients with Recurrent Pregnancy Loss.</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of Tacrolimus Efficacy in Patients with Recurrent Pregnancy Loss.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Recurrent Pregnancy Loss ..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group .Tacrolimus prescription. Intervention 2: Control group: Follow pregnant women without take Tacrolimus.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayyeh Shaikhalian Zafarghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, Unit 10, 4th Floor، Eftekhariyan Street, Azizi AlleyPasdaran, Heravi Square, Mobarak Abad 3-way,Tehran,Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1669743789</zip>
        <telephone>+98 912 612 0791</telephone>
        <email>mahyar.fasihi80@gmail.com</email>
        <affiliation>Avicenna Infertility Center Dr. Shariati Street, Yakhchal Street,Tehran,Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayyeh Shaikhaluan Zafatghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, Unit 10, 4th Floor, Azizi Alley, Eftekhariyan Street, Heravi Square, Mobarak Abad 3-way, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1669743789</zip>
        <telephone>+98 912 612 0791</telephone>
        <email>mahyar.fasihi80@gmail.com</email>
        <affiliation>Avicenna Infertility Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged between 20 and 39 years.
Patients who presented for treatment of recurrent miscarriage (three or more miscarriages before 12 weeks of gestation, with documented fetal heart rate [FHR]).
Patients with unexplained infertility despite evaluation, including assessment of ovulatory function, tubal patency, uterine anatomical abnormalities, cervical factors, and sperm quality and quantity.
Patients who are able to continue regular follow-up visits during the study period.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>39 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients using immunosuppressive medications for infertility treatment, such as azathioprine, mizoribine, mycophenolate mofetil, cyclophosphamide, sirolimus, everolimus, cyclosporine, basiliximab, etanercept, golimumab, cantuzumab, tocilizumab, conatumumab, corticosteroids, or intravenous immunoglobulin (IVIG).
Chronic endometritis diagnosed by endometrial biopsy.
Uterine anomalies, uterine fibroids, endometrial polyps, or intrauterine adhesions.
Active infections including HIV, hepatitis B, hepatitis C, or other active viral diseases.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Tacrolimus</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tacrolimus Efficacy in Patients with Recurrent Pregnancy Loss .</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 .Tacrolimus prescription</i_keyword>
      <i_keyword>Control group: Follow pregnant women without take Tacrolimus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Live Births . Timepoint: Evaluation of the Effect of Tacrolimus on Recurrent Pregnancy Loss Based on the Number of Live Births 18 month evaluation. Method of measurement: Evaluation of the Effect of Tacrolimus on Recurrent Pregnancy Loss Based on the Number of Live Births.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>No. 971941913114، Yakhchal Street، Dr. Shariati Street, Tehran, Iran.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-25</approval_date>
        <contact_name>Avicenna Research Institute, Iranian Academic Center for Education, Culture and Research (ACECR)</contact_name>
        <contact_address>Shahid Beheshti University, Rashideddin Fazlollah Street, Yemen Street, Chamran Expressway (North to South), Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
