<?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>IRCT20180219038792N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-02</date_registration>
      <primary_sponsor>Iranian academic center for education culture and research</primary_sponsor>
      <public_title>Comparison of double stimulation protocol with high dose of gonadotropin protocol in patients with poor ovarian response</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of double stimulation protocol to the approach using antagonist with high dose of gonadotropin in patients with poor ovarian response in avicenna infertility center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random specific code was allocated for each of 500 poor responders. A sample size of 60 was calculated based on the relating formula. 60 patients with poor response were randomly selected and divided into two groups of 30. Group A was selected for intervention and group B was considered as control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Poor ovarian responds patients.</hc_freetext>
      <i_freetext>Intervention 1: This study is a prospective randomized clinical trial. Patients who are nominated for ICSI because of POR are divided into two groups of 30 individuals randomly. After completing the consent, they will be placed in Double Stimulation group or a high dose antagonist gonadotrophin. First group, the starting day of the menstrual period begins with letrozole and clomiphene, and from the fourth day starts 150 units of gonadotrophin. Intervention 2: Control group: second group from the second day of the menstrual cycle, gonadotrophin starts at a dose of 450-400 units, and the dose is adjusted depending on the response of the ovaries. Both groups were evaluated for the number and quality of oocytes and embryos obtained, pregnancy status and serum levels of FSH, LH, Estradiol, Progesterone.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Montazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal Junction, Shariati St., Tehran, Iran Phone: 23519-021</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19419113114</zip>
        <telephone>+98 21 23519</telephone>
        <email>f.montazeri@ari.ir</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farnaz Montazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 97, Yakhchal Junction, Shariati St., Tehran, Iran Phone: 23519-021</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>f.montazeri@ari.ir</email>
        <affiliation>Iranian academic center for education culture and research</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 40.
History of getting less than four oocyte retival in previous cycle
Abnormal ovarian reserve tests.
History of previous ovarian surgery or history of chemotherapy
Different risk factors involved in ovarian response weakness</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>BMI value is equal to 35 and higher
FSH more than 25
Grade 3 endometriosis and higher
Any contraindication for ovarian stimulation such as uncontrolled systemic diseases
Sever male infertility based on WHO indexes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E28</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ovarian dysfunction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study is a prospective randomized clinical trial. Patients who are nominated for ICSI because of POR are divided into two groups of 30 individuals randomly. After completing the consent, they will be placed in Double Stimulation group or a high dose antagonist gonadotrophin. First group, the starting day of the menstrual period begins with letrozole and clomiphene, and from the fourth day starts 150 units of gonadotrophin.</i_keyword>
      <i_keyword>Control group: second group from the second day of the menstrual cycle, gonadotrophin starts at a dose of 450-400 units, and the dose is adjusted depending on the response of the ovaries. Both groups were evaluated for the number and quality of oocytes and embryos obtained, pregnancy status and serum levels of FSH, LH, Estradiol, Progesterone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1-The number of retrieved oocytes. Timepoint: Measuring the number of follicles in the first menstrual cycle and after taking ovulation-inducing drugs. Method of measurement: Ultrasouand system.</prim_outcome>
      <prim_outcome>The number and quality of the obtained embryos. Timepoint: In follicular and luteal phase. Method of measurement: Ultrasouand system.</prim_outcome>
      <prim_outcome>Measurement of serum Progesterone. Timepoint: On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Measurement of serum E2,. Timepoint: On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Measurement of serum LH. Timepoint: On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>Measurement of serum FSH. Timepoint: On the day the gonadotropins started, and on the day of the trigger with Deca in the follicular and luteal phase. Method of measurement: ELISA.</prim_outcome>
      <prim_outcome>The quantity of retrieved oocytes. Timepoint: Measuring  in the first menstrual cycle and after taking ovulation-inducing drugs. Method of measurement: Ultrasouand system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of pregnancy and successful birth. Timepoint: After 9 months. Method of measurement: Number of successful pregnancies and live births.</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>2017-05-02</approval_date>
        <contact_name>Ethics committee of avesina research institue</contact_name>
        <contact_address>No. 97, Yakhchal Junction, Shariati St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
