<?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>IRCT2014031112307N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Controlled trial of comparison of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women</public_title>
      <acronym></acronym>
      <scientific_title>Controlled trial of comparison of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12396</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Contrlled Ovarian Stimulation protocols.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the gonadotropin releasing hormone agonist long protocol group, the administration of Buserelin acetate 500 μg/d is started subcutaneously proceeding the IVF cycle from day 21 until pituitary down regulation. The Buserelin dose is reduced to 250 μg/d until the day of human chorionic gonadotropin (hCG) injection when pituitary down regulation was achieved. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day. Intervention 2: Intervention group: In the gonadotropin releasing hormone antagonist fixed multi-dose protocol group, Cetrorelix acetate 0.25 mg/day subcutaneously is initiated on the sixth day of the gonadotropin stimulation until the day of hCG injection. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM until the day of human chorionic gonadotropin injection. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Seyed Mohammad Hossein Noori Mugahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Histology Department, School of Medcine, Pour Sina St., Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8895 3008</telephone>
        <email>Noorimoo@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Sadat Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Deputy of Research of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8163 3619</telephone>
        <email>fshoseini@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age 18-40 years; normal serum level of steroidal hormones; male infertility, tubal factor infertility and unexplained infertility.&#13;
Exclusion criteria: genetic diseases; moderate or severe endometriosis and poly cystic ovarian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</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>Control group: In the gonadotropin releasing hormone agonist long protocol group, the administration of Buserelin acetate 500 μg/d is started subcutaneously proceeding the IVF cycle from day 21 until pituitary down regulation. The Buserelin dose is reduced to 250 μg/d until the day of human chorionic gonadotropin (hCG) injection when pituitary down regulation was achieved. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day.</i_keyword>
      <i_keyword>Intervention group: In the gonadotropin releasing hormone antagonist fixed multi-dose protocol group, Cetrorelix acetate 0.25 mg/day subcutaneously is initiated on the sixth day of the gonadotropin stimulation until the day of hCG injection. Ovarian stimulation is started on the 3rd day of the current menstrual cycle by injection of rFSH Follitropin alfa (Gonal F) at a daily dose of 150 to 225 IU/IM until the day of human chorionic gonadotropin injection. Human chorionic gonadotropin 5000 IU /2/IM is injected about 34–36 hrs before oocytes pickup day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of the effect of controlled ovarian stimulation protocols on gene expression of germinal vesicle oocytes in infertile women. Timepoint: ٍEnd of sampling. Method of measurement: Real Time PCR.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determination of the effect of controlled ovarian stimulation protocols on adenosine triphosphatase 6 gene expression of human germinal vesicle oocytes. Timepoint: The end of sampling. Method of measurement: Real Time PCR.</sec_outcome>
      <sec_outcome>Determination of the effect of controlled ovarian stimulation protocols on growth differentiation factor 9 gene expression of human germinal vesicle oocytes. Timepoint: The end of sampling. Method of measurement: Real Time PCR.</sec_outcome>
      <sec_outcome>Determination of the effect of controlled ovarian stimulation protocols on bone morphogenetic protein15 gene expression of human germinal vesicle oocytes. Timepoint: The end of sampling. Method of measurement: Real Time PCR.</sec_outcome>
      <sec_outcome>Determination of the effect of controlled ovarian stimulation protocols on neuronal apoptosis inhibitory protein gene expression of human germinal vesicle oocytes. Timepoint: The end of sampling. Method of measurement: Real Time PCR.</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>2012-11-25</approval_date>
        <contact_name>Vice chancellor for Research,Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods St., Keshavarz Blvd., Teharn Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
