<?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>IRCT20180619040147N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-21</date_registration>
      <primary_sponsor>Iranian Academic Center for Education Culture and Research</primary_sponsor>
      <public_title>Evaluation of  the safety and  feasibility of  intra ovarian injection of  menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of  the safety and  feasibility of  intra ovarian injection of  menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31980</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: In order to randomly assign 36 subjects in treatment group or control group, 6 blocks including 6 subjects each will be defined using "https://app.studyrandomizer.com". Treatment group and control group will be identified by codes A and B, respectively. In each block, number of treatment group and control group is equal and situation of each block with other block is different.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Poor ovarian response.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes 18 patients with poor ovarian response that will be treated by once injection of  autologous menstrual blood stem cells. After cells isolation, culture and qualification in GMP grade- clean room of STERCO (Tehran, Iran), they will be intravaginally injected  by vaginal ultrasonography  into left ovary of patients after receiving general anesthesia. Intervention 2: Control group: includes 18 patients with poor ovarian response that will not receive any intervention and their biochemical parameters, sonographic  and embryologic data will be compared with intervention group.</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>Somaieh Kazemnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1936773493</zip>
        <telephone>+98 21 2243 2020</telephone>
        <email>kazemnejad_s@yahoo.com</email>
        <affiliation>Iranian Academic Center for Education Culture and Research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somaieh Kazemnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1936773493</zip>
        <telephone>+98 21 2243 2020</telephone>
        <email>kazemnejad_s@yahoo.com</email>
        <affiliation>Iranian Academic Center for Education Culture and Research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Got married woman
Picked up less than 3 oocytes in last ovarian stimulation
Anti mullerian hormone; less than 1.1 ng/ml
Upper age limit: 40
Spermogram: more than 5 million/ml, normal morphology more than 1, sperm motility (A+B) more than 25%
Anteral follicles: less than 5-7</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Thyroid dysfunction
Immune disorders
History of cancer, chemotherapy and radiotherapy
Infected by hepatitis B,C or HIV
Severe endometriosis
History of ovarian surgery
Diabetes
Dysfunction of electrolyte or liver tests
Psychological problem like depression, high stress an anxiety</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E89.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asymptomatic postprocedural ovarian failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: includes 18 patients with poor ovarian response that will be treated by once injection of  autologous menstrual blood stem cells. After cells isolation, culture and qualification in GMP grade- clean room of STERCO (Tehran, Iran), they will be intravaginally injected  by vaginal ultrasonography  into left ovary of patients after receiving general anesthesia.</i_keyword>
      <i_keyword>Control group: includes 18 patients with poor ovarian response that will not receive any intervention and their biochemical parameters, sonographic  and embryologic data will be compared with intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number  of antral follicles in ovary. Timepoint: Before intervention, 3 months and 6 months after cell administration. Method of measurement: Vaginal sonography.</prim_outcome>
      <prim_outcome>Anti Mullerian hormone level in blood serum. Timepoint: Before intervention, 3 months, 6 months and one year after cell administration. Method of measurement: biochemical assay.</prim_outcome>
      <prim_outcome>Number and quality of oocytes in  intra-cytoplasmic sperm injection cycle. Timepoint: first  intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryologic evaluation.</prim_outcome>
      <prim_outcome>Spontaneous pregnancy. Timepoint: up to 3 months after intervention. Method of measurement: beta-HCG assay.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Implantation rate. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: Vaginal sonography.</sec_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 6-8 weeks after last menstrual period. Method of measurement: Vaginal sonography.</sec_outcome>
      <sec_outcome>Live birth. Timepoint: 9 months after pregnancy. Method of measurement: delivery report based on gynecologist comment.</sec_outcome>
      <sec_outcome>Embryo quality and number. Timepoint: in new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: embryology report.</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>Iranian Academic Center for Education Culture and Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-06</approval_date>
        <contact_name>Academic Center for Education, Culture and Research (ACECR)- Biomedical Research Ethics Committee</contact_name>
        <contact_address>1270, Secretariat of the Ethics Committee of ACECR,Deputy Director of Research and Technology,  Headquarters of ACECR, Opposite the main door of Tehran University,  Enghelab Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
