<?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>IRCT2013060913605N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-18</date_registration>
      <primary_sponsor>Avicenna Infertility  Clinic</primary_sponsor>
      <public_title>The effect of intrauterine injection of human chorionic gonadotropin (hCG) before embryo transfer on the implantation and pregnancy rates in the intracytoplasmic sperm injection (ICSI)</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effect of intrauterine injection of human chorionic gonadotropin (hCG) before embryo transfer on the implantation and pregnancy rates in the intracytoplasmic sperm injection (ICSI) method among patients who referred to Avicenna Infertility Clinic during 2013-2014.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>121</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13421</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Explanation regarding blinding of the study: It is evident that researcher is aware of the intervention but who performs the intervention is unaware and is not from research group. Moreover, according to informed consent, participants should be informed that may receive a certain drug but they are not aware of their group. All steps of the study are similar for both groups except that controls receive only culture media instead of hCG plus culture media in the treatment group; neither the patient nor the operator is aware of the content of the instillation.  It seems there is no problem regarding the blindness of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intrauterine injection of hCG and embryo transfer in the treatment group:  immediately before embryo transfer, 500 IU of hCG dissolved in 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity. Intervention 2: Intrauterine injection of placebo and embryo transfer in the control group: immediately before embryo transfer only 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity.</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 Bita Badehnoosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 97, Yakhchal - Shariati Junction, Shariati St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>B.Badehnoosh@avicenna.ac.ir; badehnoosh@dr.com; b_badehnoosh@yahoo.com</email>
        <affiliation>Avicenna Infertility  Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Bita Badehnoosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 97, Yakhchal - Shariati Junction, Shariati St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941913114</zip>
        <telephone>+98 21 23519</telephone>
        <email>B.Badehnoosh@avicenna.ac.ir; badehnoosh@dr.com; b_badehnoosh@yahoo.com</email>
        <affiliation>Avicenna Infertility  Clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: age between 20 and 40 yr; infertility due to male factor, PCO, or with unknown cause; informed consent from couples; obtaining high quality embryos&#13;
&#13;
Exclusion criteria: azoospermia or severe oligoasthenoteratospermia; previous successful or failed IVF/ICSI; myometrium or any uterus abnormality; previous myomectomy; moderate to severe endometriosis; hydrosalpynx; obtaining more than 20 ovums or probable OHSS; nonadherence to the study protocol</inclusion_criteria>
      <agemin>20 years</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intrauterine injection of hCG and embryo transfer in the treatment group:  immediately before embryo transfer, 500 IU of hCG dissolved in 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity.</i_keyword>
      <i_keyword>Intrauterine injection of placebo and embryo transfer in the control group: immediately before embryo transfer only 40 microliter culture media is instilled into the uterine cavity using an insemination catheter. After that, embryos are transferred into the uterine cavity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Implantation rate. Timepoint: 2 weeks after embryo transfere. Method of measurement: Serum level of B-hCG (mIU/ml) based on laboratory report.</prim_outcome>
      <prim_outcome>Pregnancy rate. Timepoint: 3 weeks after positive serum B-hCG. Method of measurement: Detection of gestational sac by ultrasonographic exam.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of B-hCG. Timepoint: 2 weeks after embryo transfere. Method of measurement: mIU/ml based on laboratory report.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>No secondary ID</sec_id>
        <issuing_authority>No secondary ID</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Avicenna Infertility  Clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-06-25</approval_date>
        <contact_name>Ethics committee of Avicenna Infertility  Clinic</contact_name>
        <contact_address>No 97, Yakhchal - Shariati Junction, Shariati St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
