<?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>IRCT20240815062771N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Injection of Plasma Rich in Growth Factor (PRGF) in infertile women with poor ovarian response</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of intraovarian platelet rich plasma activated with calcium gluconate and growth factors injection on infertile women with poor ovarian response and assisted reproductive techniques (ART) outcomes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81440</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Considering that this therapeutic intervention is interventional, it is not possible to perform blinding for the patient and the treating physician. However, the responsible physician for assessing the outcomes and the analyzing physician are blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>poor ovarian response.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: PRP extracted from the patient's own blood sample into ovarian cortex. Intervention 2: Intervention group: Injection of activated platelet-rich plasma with calcium gluconate into the ovarian cortex. Intervention 3: Intervention group: Injection of platelet-rich plasma enriched with growth factors into the ovarian cortex (PRGF).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The patients' personal information will be kept completely confidential and only the test results and outcomes will be published. All data obtained in the research will be published in a reputable and relevant scientific journal.

When:
April 2026

To whom:
Researchers working in academic institutions

Conditions:
The data from this study can be used as an adjuvant treatment in patients with poor ovarian response undergoing IVF/ICSI and will be made available only to researchers and therapists in the medical field.

Where to obtain:
Mahshad Khodarahmian
Email: ma_khodarahmian@gmail.com

How to obtain:
By sending an email to the correspond author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshad Khodarahmian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods Street, Poursina Street, Faculty of Medicine, Department of Anatomical Sciences, Room 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 6649 2277</telephone>
        <email>ma.khodarahmian@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshad Khodarahmian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods Street, Poursina Street, Faculty of Medicine, Department of Anatomical Sciences, Room 3</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 6649 2277</telephone>
        <email>ma.khodarahmian@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20-42 years
Three or fewer oocytes retrieved in at least one previous ovarian stimulation cycle and an abnormal ovarian reserve test or an antral follicle count of less than five to seven or AMH &lt;0.5–1.1 ng/mL
No fertility problems in the patient's husband</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Ovarian failure due to gonadal dysgenesis and chromosomal abnormalities
Immunoglobulin A deficiency
History of major pelvic floor surgery that has resulted in severe pelvic adhesions.
Use of anticoagulants
Use of psychotropic medications
Presence of psychiatric disorders
Cancer
History of chronic pelvic pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other ovarian dysfunction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: PRP extracted from the patient's own blood sample into ovarian cortex</i_keyword>
      <i_keyword>Intervention group: Injection of activated platelet-rich plasma with calcium gluconate into the ovarian cortex</i_keyword>
      <i_keyword>Intervention group: Injection of platelet-rich plasma enriched with growth factors into the ovarian cortex (PRGF)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of eggs retrieved during oocyte retrieval. Timepoint: After oocyte retrieval. Method of measurement: Embryologist report.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anti Mullerian Hormone (AMH) level. Timepoint: Before injection, 1 month after injection and 3 months after injection. Method of measurement: Measurement in blood plasma with ELISA kit.</sec_outcome>
      <sec_outcome>Estradiol Hormone level. Timepoint: Before injection, 1 month after injection and 3 months after injection. Method of measurement: Measurement in blood plasma with ELISA kit.</sec_outcome>
      <sec_outcome>Follicle-Stimulation Hormone (FSH) level. Timepoint: Before injection, 1 month after injection and 3 months after injection. Method of measurement: Measurement in blood plasma with ELISA kit.</sec_outcome>
      <sec_outcome>Antral ovarian follicles count. Timepoint: Before injection, 1 month after injection and 3 months after injection. Method of measurement: Ultrasound.</sec_outcome>
      <sec_outcome>Number of embryos. Timepoint: 72 hours after oocyte retrieval. Method of measurement: Embryologist report.</sec_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: Human chorionic gonadotropin (HCG) serum level.</sec_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: Observation of the presence of at least one gestational sac within the uterine cavity by ultrasound.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-05</approval_date>
        <contact_name>ٍEthics Committee of the Research Institute of Oncology, Hematology, and Cell Therapy</contact_name>
        <contact_address>North Kargar Street, Shariati Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
