<?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>IRCT20181216042006N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-11</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the therapeutic effect of PRP (Platelet-Rich Plasma) in ovarian function</public_title>
      <acronym>prp</acronym>
      <scientific_title>Investigating the therapeutic effect of PRP (Platelet-Rich Plasma) in improving ovarian function in patients with infertility</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69420</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Women with poor response to ovarian stimulation.</hc_freetext>
      <i_freetext>Intervention group: (Women with poor response to ovarian stimulation) The statistical population of the study will be 20 infertile women referred to Roish Birjand clinic with poor response to ovarian stimulation and IVF candidates. The results of the tests related to AMH, FSH, LH and the number of AFC of the patients will be recorded by reviewing the patients' files before the intervention. The next step is the sampling of the PRP preparation. From all participants, 20 cc of blood with citrate anticoagulant will be taken. It will be taken. Using a centrifuge at a specified speed, the plasma will be separated and transferred to sterile tubes. In the next step, a high-speed centrifuge is performed according to the instructions of the kit to separate the platelet-rich plasma.In the follicular phase and in the early periods of the menstrual cycle, PRP injection will be performed under sterile conditions and under the guidance of transvaginal ultrasound in each ovary under general anesthesia by an anesthesiologist in the operating room of Roish Clinic in a stromal manner by a gynecologist. After regaining consciousness, she will be discharged. Finally, hormonal tests of AMH, FSH, LH and sonography will be performed by a gynecologist to determine the number of AFC in the first menstrual cycle after treatment to determine the effect..</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 Due to the privacy of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atena mansouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cellular and Molecular Research Center, Faculty of Medicine, Birjand University of Medical Sciences, 21/1 Ghafari Corner, Ayatollah Ghafari Street, Birjand City, South Khorasan Province, Iran</address>
        <city>BIRJAND</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853076</zip>
        <telephone>+98 56 3238 1259</telephone>
        <email>mansouri_atena@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad fereidouni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cellular and Molecular Research Center, Faculty of Medicine, Birjand University of Medical Sciences, 21/1 Ghafari Corner, Ayatollah Ghafari Street, Birjand City, South Khorasan Province, Iran</address>
        <city>BIRJAND</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853076</zip>
        <telephone>0098 32381259</telephone>
        <email>Dr.m.fereidouni@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 25 to 45 years
The amount of FSH hormone is higher than 12
The amount of AMH hormone is lower  than 1
Poor response to ovulation stimulating drugs in previous cycles
Donor egg candidate</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of any ovarian cyst confirmed by a gynecologist
People with polycystic ovary confirmed by a gynecologist
People with underlying medical diseases (hypertension and diabetes)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility associated with anovulation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: (Women with poor response to ovarian stimulation) The statistical population of the study will be 20 infertile women referred to Roish Birjand clinic with poor response to ovarian stimulation and IVF candidates. The results of the tests related to AMH, FSH, LH and the number of AFC of the patients will be recorded by reviewing the patients' files before the intervention. The next step is the sampling of the PRP preparation. From all participants, 20 cc of blood with citrate anticoagulant will be taken. It will be taken. Using a centrifuge at a specified speed, the plasma will be separated and transferred to sterile tubes. In the next step, a high-speed centrifuge is performed according to the instructions of the kit to separate the platelet-rich plasma.In the follicular phase and in the early periods of the menstrual cycle, PRP injection will be performed under sterile conditions and under the guidance of transvaginal ultrasound in each ovary under general anesthesia by an anesthesiologist in the operating room of Roish Clinic in a stromal manner by a gynecologist. After regaining consciousness, she will be discharged. Finally, hormonal tests of AMH, FSH, LH and sonography will be performed by a gynecologist to determine the number of AFC in the first menstrual cycle after treatment to determine the effect.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FSH hormone level. Timepoint: A few days before the injection and the first menstrual cycle after the injection. Method of measurement: Measurement in the laboratory.</prim_outcome>
      <prim_outcome>AMH hormone level. Timepoint: A few days before the injection and the first menstrual cycle after the injection. Method of measurement: Measurement in the laboratory.</prim_outcome>
      <prim_outcome>LH hormone level. Timepoint: A few days before the injection and the first menstrual cycle after the injection. Method of measurement: Measurement in the laboratory.</prim_outcome>
      <prim_outcome>AFC number. Timepoint: A few days before the injection and the first menstrual cycle after the injection. Method of measurement: sonography.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-20</approval_date>
        <contact_name>Ethics Committeeof Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences, 21/1 Ghafari corner, Ayatollah Ghafari St, Birjand city, South Khorasan province, Iran BIRJAND South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
