<?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>IRCT20160722029027N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-31</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of intraovarian injection of platelet rich plasma on ovarian reserve in infertile women due to decreased ovarian reserve</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of intraovarian injection of platelet rich plasma on ovarian reserve in infertile women due to decreased ovarian reserve</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention group: In all women included in the study and after collecting background information such as demographic characteristics and records related to previous pregnancy, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG) (250 micrograms) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with ultrasound guidance. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle..</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:
6 months after the end of the study

When:
6 months after the end of the study

To whom:
6 months after the end of the study

Conditions:
6 months after the end of the study

Where to obtain:
6 months after the end of the study - project manager

How to obtain:
6 months after the end of the study, she can request from the project manager

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4631 19395</zip>
        <telephone>+98 21 2243 9872</telephone>
        <email>nazari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4631- 19395</zip>
        <telephone>+98 21 2243 9872</telephone>
        <email>nazari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with infertility under 42 years old with diminished ovarian reserve as AMH&lt;1ng/ml or AFC&lt;5
Infertile women with poor ovarian response: with a history of retrieving less than 5 eggs in IVF</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Infertility due to inflammation
Endometriosis and PID
Hyperandrogenism and PCO
Anatomical disorder
Anatomical disorder
Platelet defects
bleeding disorders</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>Intervention group: In all women included in the study and after collecting background information such as demographic characteristics and records related to previous pregnancy, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG) (250 micrograms) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with ultrasound guidance. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduced ovarian reserve: AMH serum level&lt;1ng/ml or AFC&lt;5 in women under 42 years of age. Timepoint: 2 months. Method of measurement: In all women included in the study, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG) (250 micrograms) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with ultrasound guidance. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-31</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Ethics committee of Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
