<?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>IRCT2016031427045N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-09</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome in IVF cycles.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of low dose hCG with GnRH agonist in decreasing rate of ovarian hyper stimulation syndrome in IVF cycles in Omid clinic and Shariati hospital in Teharn in 1394 and 1395.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22265</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Female infertility.</hc_freetext>
      <i_freetext>Intervention 1: Interventional group receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) is injected. After 36 hours, low dose hCG is injected and oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected. Intervention 2: Control group, receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) and low dose hCG are injected. After 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected.</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 Venus Chegini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, North Karegar Street, Tehran, Obstetric and Gynecologic Unit</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8800 8810</telephone>
        <email>venus_chegini@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences, Shariati Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Marzieh Aghahosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Infertility Department, Shariati Hospital, North Karegar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8800 8810</telephone>
        <email>aghahosseini@sina.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:                                                                                                                Infertile women with following conditions: 18-39 year old; Normal FSH level; AMH&gt;3.5 ng/ml; Poly cystic ovary (AFC&gt;24); Previous ovarian hyper stimulation syndrome; in the day of oocyte retrieval the number of follicles bigger than 18mm&gt;16 or Estradiol&gt;4000 pg/ml&#13;
Exclusion criteria:  Maternal age&gt;40 year; Hypothalamic dysfunction.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications associated with artificial fertilization, Hyperstimulation of ovaries</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional group receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) is injected. After 36 hours, low dose hCG is injected and oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected.</i_keyword>
      <i_keyword>Control group, receives 150 IU FSH daily from the second day of menses. When the 14 mm follicles is observed in transvaginal ultrasound GnRH antagonist (Cetrorelix) 0.25mg subcutaneously daily is added. After the observation of at least two 18mm follicles, GnRH agonist (Bucerellin 0.5 mg) and low dose hCG are injected. After 36 hours oocyte retrieve is performed under general anesthesia. Three days after fertilization, transcervical embryo transfer will be carried out. Symptoms and signs of OHSS (Abdominal pain, Oliguria, Weight gaining, Nausea and Vomiting) are evaluated during 2 weeks after oocyte retrieval. Pregnancy test is checked 14 days after embryonal transfer. 2 weeks after positive test, by the aid of transvaginal ultrasound the pregnancy sac and fetal heart are detected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ovarian hyper stimulation syndrome. Timepoint: 2 weeks after embryonal transfer. Method of measurement: Transvaginal ultrasonography and examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chemical Pregnancy. Timepoint: 14 days after embryonal transfer. Method of measurement: βhCG titration.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: 4 weeks after embryonal transfer. Method of measurement: Observationl of gestational sac in transvaginal sonography.</sec_outcome>
      <sec_outcome>Clinical pregnancy rate. Timepoint: 2 weeks after positive pregnancy test. Method of measurement: Observation of gestational sac in transvaginal sonography.</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>2015-12-28</approval_date>
        <contact_name>Ethic Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Ethic Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
