<?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>IRCT2017052834184N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-07</date_registration>
      <primary_sponsor>vice chancellor of research Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>comparison between pregnancy outcome of in vitro fertilization (assisted reproductive technology ) with and without Gonadotropin-releasing hormone agonist</public_title>
      <acronym></acronym>
      <scientific_title>Frozen Thawed Embryo Transfer Cycles: A Comparison of Pregnancy Outcomes with and without Prior Pituitary Suppression by Gonadotropin-releasing hormone Agonists</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: in vitro fertilization. Condition 2: infertility.</hc_freetext>
      <i_freetext>Intervention 1: Participanpatients in group A received GnRH agonist prior to ovulation induction.0.5 mg of Busereline acetate (a GnRH agonist) (Suprefact, Hoechst AG, Germany) was injected subcutaneously daily starting on the 21st day of menstrual cycle (mid luteal phase). On the first day of menstruation, GnRH agonist dose was reduced to 0.3 mg SC per day. Intervention 2: patients in group B had steroid manipulation and routine IVF regimen without prior down-regulation of the pituitary.</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>Zohre Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ob/Gyn department office, Shahid Faghihi Hospital,Zand St</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 714 4835</telephone>
        <email>z.chitsazi@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohre Chitsazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ob/Gyn department office, Shahid Faghihi hospital,,Zand st</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 917 714 4835</telephone>
        <email>z.chitsazi@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: &#13;
 Documented infertility of any cause;Aged 20-39 years; Couples undergoing ART with their own gametes;Women stimulated with a long GnRH agonist protocol of IVF (for group A);Couples having frozen embryo available for transfer&#13;
&#13;
exclusion criteria:&#13;
Age &gt; 39 years; High grade endometriosis;Existence of myoma or adhesion in uterus;Body mass index (BMI) more than 29 kg/m2 or less than 18 kg/m2;Oocyte donation cycles</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>39 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z31.2</hc_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Admission for harvesting or implantation of ova</hc_keyword>
      <hc_keyword>inability to achieve a pregnancy</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>Participanpatients in group A received GnRH agonist prior to ovulation induction.0.5 mg of Busereline acetate (a GnRH agonist) (Suprefact, Hoechst AG, Germany) was injected subcutaneously daily starting on the 21st day of menstrual cycle (mid luteal phase). On the first day of menstruation, GnRH agonist dose was reduced to 0.3 mg SC per day.</i_keyword>
      <i_keyword>patients in group B had steroid manipulation and routine IVF regimen without prior down-regulation of the pituitary</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy outcome. Timepoint: since 16 days post transfer until delivery. Method of measurement: beta hCG, Ultrasound.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 5 weeks after transfer date. Method of measurement: observation of intrauterine gestational sac during ultrasound examination 5 weeks after transfer date.</sec_outcome>
      <sec_outcome>Chemical pregnancy. Timepoint: 16 days following thawed embryo transfer. Method of measurement: Serum βHCG level &gt; 10 IU per L.</sec_outcome>
      <sec_outcome>Ongoing pregnancy. Timepoint: 12 weeks after transfer date. Method of measurement: presence of intrauterine fetal heart motion.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: 9 weeks post transfer. Method of measurement: number of gestational sacs with fetal pole detected using vaginal ultrasound to the number of transferred embryos.</sec_outcome>
      <sec_outcome>Miscarriage rate. Timepoint: under the 20th week of gestation. Method of measurement: ultrasound and beta hCG.</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>vice chancellor of research Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethical Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences,  Zand ST, Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
