<?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>IRCT20141217020351N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The sequential embryo transfer compared to single embryo transfer in one cycle</public_title>
      <acronym></acronym>
      <scientific_title>The sequential embryo transfer  in the third and fifth day compared to single embryo transfer  in the fifth day in IVF cycle</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29988</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: they were allocated to one of two groups via simple random sampling,  using a random Pocket (intervention or Control)by the same coordinator.Patients were allocated to either sequential transfer (day 3 and day 5) or conventional transfer (day 5) protocols.</study_design>
      <phase>3</phase>
      <hc_freetext>Infertility,Repeated implantation failure,ٍEmbryo transfer,Blastocyst.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients were randomized to one of the 2 groups of  Intervention and control .After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means,  oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then  ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3.  Once post-fertilization check confirmed availability of ≥5 embryos, . In the third day after injection, embryo quality was evaluated, and 1 good-quality embryos were transferred (Cleavage in fresh cycles). Also, embryos were transferred to Blastocyst medium (Sydney IVF blastocyst medium) for 48 h. Then, on the fifth day, two embryos (Blastocyst) were transferred to the uterus. Intervention 2: Control group: After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means,  oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then  ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3.  Once post-fertilization check confirmed availability of ≥5 embryos,  In the control group, on the fifth day, two embryos (Blastocyst) were transferred to the uterus.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Maintaining privacy in patient data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ensieh Shahrokh Tehraninejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr Infertility Clinic,Imam Khomeini Hospital,Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>etehraninejad@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ensieh Shahrokh Tehraninejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vali Asr Infertility Clinic ,Imam Khomeini Hospital,Keshavarz BLvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14194</zip>
        <telephone>+98 21 6658 1616</telephone>
        <email>etehraninejad@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>age ≤ 40 years
normal karyotype
normal screening of immunological and thrombolytic condition
the absence of endometrial abnormalities by hysteroscopy
availability of ≥5 embryos</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>potential poor  responders
Ovarian hyper stimulation response
presence of medical diseases</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 - Surgery</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients were randomized to one of the 2 groups of  Intervention and control .After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means,  oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then  ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3.  Once post-fertilization check confirmed availability of ≥5 embryos, . In the third day after injection, embryo quality was evaluated, and 1 good-quality embryos were transferred (Cleavage in fresh cycles). Also, embryos were transferred to Blastocyst medium (Sydney IVF blastocyst medium) for 48 h. Then, on the fifth day, two embryos (Blastocyst) were transferred to the uterus.</i_keyword>
      <i_keyword>Control group: After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means,  oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then  ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3.  Once post-fertilization check confirmed availability of ≥5 embryos,  In the control group, on the fifth day, two embryos (Blastocyst) were transferred to the uterus.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: Two weeks after  the stopping the menstruation. Method of measurement: Blood sample for B-HCG.</prim_outcome>
      <prim_outcome>Clinical Pregnancy. Timepoint: Six weeks after seeing the embryo sac in ultrasound. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Abortion. Timepoint: After positive pregnancy test. Method of measurement: Blood sample of B-HCG.</sec_outcome>
      <sec_outcome>Ectopic pregnancy. Timepoint: After the positive of pregnancy test. Method of measurement: 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-11</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No.6,Ghods Ave,Keshavarz Blvd,Deputy of Research of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
