<?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>IRCT201105016345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Bromocriptine rebound method on Intracytoplasmic sperm injection cycles outcome</public_title>
      <acronym></acronym>
      <scientific_title>a randomized clinical trial to compare the effect of bromocriptine-rebound method on ongoing pregnancy and live birth after Intracytoplasmic sperm injection cycles with long protocol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>IVF/ICSI.</hc_freetext>
      <i_freetext>Intervention 1: intervention : similar to long protocol except administration of  Bromocriptine 2.5 mg per day since day 4 of follicular phase till 7 days before gonadotropine syimulation. Intervention 2: control :     long protocol  &#13;
 In preceding cycle, OCP was administered from  day 3 for a month and Buserelin (Superfact, Aventis, Frankfurt, Germany) was started 0.5 mg daily from day 21. Then, ovarian hyper stimulation was initiated with recombinant FSH (Gonal F, Serono, and Aubnne, Switzerland) in different doses according to ovarian antral follicle count in sonography on day 2 of withdrawal bleeding. Serial ultrasound examinations were used to assess ovarian response, and then gonadotropin dose adjustments were done as required. Human chorionic gonadotropin (Pregnyl, Organon, Oss, the Netherlands) 10,000 IU was administered when at least two follicles reached a mean diameter of 18 mm. Oocytes retrieval was performed 36 hours after hCG administration and oocytes were inseminated with  ICSI. Evidence for fertilization was assessed approximately 18 h after insemination. Embryo transfer was performed on day 2. Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 25 mg daily IM and vaginal suppository Cyclogest was started on the day of oocytes retrieval and continued until the documentation of fetal heart activity on ultrasound. Chemical pregnancy was assessed based on Beta HCG after 14-15 days . 6 weeks later clinical pregnancy was documented based on presence of intra uterine gestational sac in trans vaginal sonography and ongoing pregnancy was determined if normal pregnancy last for more than 16 weeks .</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>Ramak Esmaeeli Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the beginning of  Jalal Al Ahmad High way ,  Karegar Ave, Keshavarz BLV</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8800 0085</telephone>
        <email>ramak.esmaeiliazad@yahoo.com</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramak Esmaeeli Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the beginning of  Jalal Al Ahmad High way ,  Karegar Ave, Keshavarz BLV</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8800 8810</telephone>
        <email>esmaeiliazad@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : normal endocrine pattern ; age younger than 40 yr ; normal basic serum prolactine concentrations ; ovulatory cycles ;&#13;
Exclusion criteria : severe male factor as a cause of infertility according to the WHO criteria</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z31.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>In vitro fertilization</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>intervention : similar to long protocol except administration of  Bromocriptine 2.5 mg per day since day 4 of follicular phase till 7 days before gonadotropine syimulation</i_keyword>
      <i_keyword>control :     long protocol  &#13;
 In preceding cycle, OCP was administered from  day 3 for a month and Buserelin (Superfact, Aventis, Frankfurt, Germany) was started 0.5 mg daily from day 21. Then, ovarian hyper stimulation was initiated with recombinant FSH (Gonal F, Serono, and Aubnne, Switzerland) in different doses according to ovarian antral follicle count in sonography on day 2 of withdrawal bleeding. Serial ultrasound examinations were used to assess ovarian response, and then gonadotropin dose adjustments were done as required. Human chorionic gonadotropin (Pregnyl, Organon, Oss, the Netherlands) 10,000 IU was administered when at least two follicles reached a mean diameter of 18 mm. Oocytes retrieval was performed 36 hours after hCG administration and oocytes were inseminated with  ICSI. Evidence for fertilization was assessed approximately 18 h after insemination. Embryo transfer was performed on day 2. Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 25 mg daily IM and vaginal suppository Cyclogest was started on the day of oocytes retrieval and continued until the documentation of fetal heart activity on ultrasound. Chemical pregnancy was assessed based on Beta HCG after 14-15 days . 6 weeks later clinical pregnancy was documented based on presence of intra uterine gestational sac in trans vaginal sonography and ongoing pregnancy was determined if normal pregnancy last for more than 16 weeks .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fertilized oocyte. Timepoint: 1 months after intervention. Method of measurement: embryology labratory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ongoing pregnancy &amp; Live birth. Timepoint: 16 weeks &amp; 37 weeks. Method of measurement: prenatal visits.</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 for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-02</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>Shariati Educational , Research and Healthcare Center , the beginning of  Jalal Al Ahmad High way ,  Karegar Ave, Keshavarz BLV, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
