<?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>IRCT20220809055651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-30</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>PRP in infertility</public_title>
      <acronym>PRP in infertility</acronym>
      <scientific_title>Evaluation of the effect of PRP on the outcome of IVF cycle in poorly responding patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65263</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Hematological disorders (leukemia, thrombocytopenia), immunological disorders (antiphospholipid syndrome, thrombophilia), hormonal disorders (diabetes, thyroid, hyperprolactinemia), chromosomal and genetic abnormalities (hereditary or congenital) and kidney failure.</study_design>
      <phase>2</phase>
      <hc_freetext>Evaluation of the effect of PRP on the outcome of IVF cycle in poorly responding patients.</hc_freetext>
      <i_freetext>The present study is a before and after clinical trial study that will be conducted in Shahid Beheshti Hospital, Kashan. This study will be conducted on 15 poor responder patients of group 3 and 1 poseidon. The IVF cycle begins with the administration of HMG at a dose of 300 IU/d, and on the fifth day, ultrasound stimulation is performed again. If a follicle with a size of 12 to 14 micrometers is observed, the patient is prescribed Sterotide (MG0.25). When 2 or more than 2 follicles with a size of 17 or more than 17 mm are seen in ultrasound,The final follicle stimulation is done by prescribing HCG 10000 + ptyl 0.2mg Decape for the patient. HMG Vestrotide brand is one of the drugs available in the market and PRP is Avigen brand. 36 hours after the final follicle stimulation, the ovary is punctured and after the puncture at the rate of 2.5 CC PRP is injected into each ovary. 3 months after PRP administration, FSH and AMH levels are measured in the same people, and IVF cycles are performed again with the same method as before, and the number of follicles with a size of 17 micrometers or more, the number of M2 oocytes, the percentage of fertilization, the number of embryos and the quality The embryo and the thickness of the endometrium are examined. Finally, all these criteria that were mentioned are compared with the time before PRP administration..</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>zahra usefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>esfshsn kashan - bolvare ghotbe ravandi-sayte maskonie danshghahe olome pezeshki</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715985131</zip>
        <telephone>+98 31 3650 8827</telephone>
        <email>usefi-z@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr tayebe hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan Qutub Rawandi Blvd. Kashan University of Medical Sciences residential site of the university</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715985131</zip>
        <telephone>+98 922 875 2168</telephone>
        <email>usefi-z@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This study will be conducted on 15 poor responder patients of group 3 and 1 poseidon. Inclusion criteria: age less than 35 years, BMI less than 30 and AMH&lt;1.2 ng/ml AFC&lt;5 (group 3 Poseidon) or women under 35 years and a history of poor response during IVF cycle with AMH &gt;1.2 ng/ml AFC &gt;5 (Group 1 of Poseidon).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Hematological disorders (leukemia, thrombocytopenia), immunological disorders (antiphospholipid syndrome, thrombophilia), hormonal disorders (diabetes, thyroid, hyperprolactinemia), chromosomal and genetic abnormalities (hereditary or congenital) and kidney failure.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present study is a before and after clinical trial study that will be conducted in Shahid Beheshti Hospital, Kashan. This study will be conducted on 15 poor responder patients of group 3 and 1 poseidon. The IVF cycle begins with the administration of HMG at a dose of 300 IU/d, and on the fifth day, ultrasound stimulation is performed again. If a follicle with a size of 12 to 14 micrometers is observed, the patient is prescribed Sterotide (MG0.25). When 2 or more than 2 follicles with a size of 17 or more than 17 mm are seen in ultrasound,The final follicle stimulation is done by prescribing HCG 10000 + ptyl 0.2mg Decape for the patient. HMG Vestrotide brand is one of the drugs available in the market and PRP is Avigen brand. 36 hours after the final follicle stimulation, the ovary is punctured and after the puncture at the rate of 2.5 CC PRP is injected into each ovary. 3 months after PRP administration, FSH and AMH levels are measured in the same people, and IVF cycles are performed again with the same method as before, and the number of follicles with a size of 17 micrometers or more, the number of M2 oocytes, the percentage of fertilization, the number of embryos and the quality The embryo and the thickness of the endometrium are examined. Finally, all these criteria that were mentioned are compared with the time before PRP administration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: Before entering the cycle on the fifth day of the eighth and three months later. Method of measurement: Ultrasound.</prim_outcome>
      <prim_outcome>Oocyte count. Timepoint: Before entering the cycle on the fifth day of the eighth and three months later. Method of measurement: Ultrasound (sonography).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ANTI MOULLERIAN HORMON. Timepoint: Before entering the cycle on the fifth day of the eighth and three months later. Method of measurement: Measurement by blood test analysis after eight hours of fasting and without intimacy and stress the night before.</sec_outcome>
      <sec_outcome>Follicle-stimulating Hormone. Timepoint: Before entering the cycle on the fifth day of the eighth and three months later. Method of measurement: Measurement by blood test analysis after eight hours of fasting and without intimacy and stress the night before.</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>2022-07-16</approval_date>
        <contact_name>Ethics committee of kashan University of Medical Sciences</contact_name>
        <contact_address>esfahan -kashan -daneshghah olome pezeshki kashan-saite maskonie daneshghah kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
