<?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>IRCT20221128056644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-03</date_registration>
      <primary_sponsor>Royan Institute</primary_sponsor>
      <public_title>The Efficacy of testicular PRP for patients with history of mTESE failure</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of Autologous Testicular Platelet Rich Plasma (PRP) for Patients with a History of Microdissection Testicular Sperm Extraction (mTESE) Failure: Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69854</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>1</phase>
      <hc_freetext>Non-obstructive azoospermia.</hc_freetext>
      <i_freetext>Intervention group: Patients with non-obstructive azoospermia have at least one mTESE failure history. After receiving the permission of the ethics committee in the research, the research samples are selected based on the criteria for entering the study. After obtaining informed consent to participate in the research, they will be subjected to intratesticular injection of PRP. The PRP kit ( BD Vacutainer® Specialty Tubes, SKU:364606) will be used to prepare PRP. The duration of PRP preparation will be less than 45 minutes. Prepared PRP is injected into the spermatic cord or the interstitial space using a 5 mL syringe. In the third month after testicular PRP, gonadotropin stimulation in the patient's wife begins on days 2 to 4 of the menstrual cycle. Sperm extraction with the mTESE method will be performed at the same time as the egg retrieval day to use fresh sperm cells. In the first stage, 3 months after PRP injection into the testicles, sperm analysis will be checked in patients. The second stage will be 6 months after the injection. According to the obtained results, the sperm is injected into the cytoplasm of the egg by assisted reproductive techniques (ICSI) and fertilization takes place..</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>Marjan Sabbaghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665659911</zip>
        <telephone>+98 21 2356 2000</telephone>
        <email>marjan.sabbaghian@gmail.com</email>
        <affiliation>Royan Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan Sabbaghian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave)., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665659911</zip>
        <telephone>+98 21 2356 2000</telephone>
        <email>marjan.sabbaghian@gmail.com</email>
        <affiliation>Royan Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men over 18 years
Men with a history of non-obstructive azoospermia and at least one failed mTESE
Spouses without any disease related to female infertility</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Obstructive azoospermia patients
Patients with systemic medical problems
Patients with chromosomal disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N46.029</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Azoospermia due to other extratesticular causes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with non-obstructive azoospermia have at least one mTESE failure history. After receiving the permission of the ethics committee in the research, the research samples are selected based on the criteria for entering the study. After obtaining informed consent to participate in the research, they will be subjected to intratesticular injection of PRP. The PRP kit ( BD Vacutainer® Specialty Tubes, SKU:364606) will be used to prepare PRP. The duration of PRP preparation will be less than 45 minutes. Prepared PRP is injected into the spermatic cord or the interstitial space using a 5 mL syringe. In the third month after testicular PRP, gonadotropin stimulation in the patient's wife begins on days 2 to 4 of the menstrual cycle. Sperm extraction with the mTESE method will be performed at the same time as the egg retrieval day to use fresh sperm cells. In the first stage, 3 months after PRP injection into the testicles, sperm analysis will be checked in patients. The second stage will be 6 months after the injection. According to the obtained results, the sperm is injected into the cytoplasm of the egg by assisted reproductive techniques (ICSI) and fertilization takes place.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spermatogenesis in non-obstructive azoospermia patients. Timepoint: Semen Analysis before PRP injection and ≥3 months after PRP injection. Method of measurement: Semen Analysis and Microdissection Testicular Sperm Extraction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determination of fertilization rate. Timepoint: After PRP injection. Method of measurement: Microscopic observations.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Royan Institute</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Royan Institute</source_name>
      <source_name>Royan Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-09</approval_date>
        <contact_name>Research Ethics Committees of Royan Institute- Academic Center for Education, Culture and Research</contact_name>
        <contact_address>No. 12, Royan Alley., Hafez St., Banihashem St., Qasem Soleimani Expressway (Resalat Ave) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
