<?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>IRCT20080831001141N41</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-08</date_registration>
      <primary_sponsor>ROYAN Institute</primary_sponsor>
      <public_title>Intra-ovarian injection of platelet-rich plasma in patients with premature ovarian insufficiency</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of intra-ovarian injection of platelet-rich plasma in patients with premature ovarian insufficiency; a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67760</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: A clinical trial without control group, without blinding, phase 3, on 54 patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premature ovarian insufficiency.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: Platelet-rich plasma (PRP) injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle. The injection is done under mild anesthesia and takes less than 15 minutes..</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehri Mashayekhy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>148- 16635</zip>
        <telephone>+98 21 2356 2647</telephone>
        <email>dr.mashayekhy@yahoo.com</email>
        <affiliation>ROYAN Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehri Mashayekhy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>148- 16635</zip>
        <telephone>+98 21 2356 2647</telephone>
        <email>dr.mashayekhy@yahoo.com</email>
        <affiliation>ROYAN Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with premature ovarian insufficiency according to european society of human reproduction and embryology (ESHRE) guideline
Body mass index &lt; 35 Kg/m2
Normal karyotype
Normal fragile X messenger ribonucleoprotein 1 (FMR1) gene</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Endocrine, hematologic and autoimmune disorders
Chromosomal and genetic abnormalities
Cancer history
Uterine anomalies
Sever adenomyosis
Endometriosis
Hydrosalpinx
Uterine fibromatosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Platelet-rich plasma (PRP) injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle. The injection is done under mild anesthesia and takes less than 15 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum level of follicle-stimulating hormone (FSH). Timepoint: 6-8 weeks after intra-ovarian injection of platelet-rich plasma. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Serum level of anti-mullerian hormone (AMH). Timepoint: 6-8 weeks after intra-ovarian injection of platelet-rich plasma. Method of measurement: Blood test.</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>ROYAN Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-20</approval_date>
        <contact_name>Ethics Committee of Royan Institute</contact_name>
        <contact_address>Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
