<?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>IRCT201107306420N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-09-01</date_registration>
      <primary_sponsor>Yazd research and clinical center for infertility</primary_sponsor>
      <public_title>Transfer of Blastocysts in cryopreseved cycles</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6865</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this trial, 135 infertile women who were candidate for IVF or ICSI were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention: Thawing is done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culture is done for 3 days until blastocyst development. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Transfer of embryos is done 3 days after thawing and thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound . Intervention 2: Control: Thawing is done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transfered to uterine cavity 2 hours after thawing. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All participant data sets are to be shared

When:
2 months after the result publication

To whom:
A journal in which the results are published

Conditions:
Submission of an official application via the agent that is legally incharge

Where to obtain:
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
eftekharmaryam@yahoo.com

How to obtain:
2 months after application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali avenue , Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>eftekhar@ssu.ac.ir</email>
        <affiliation>YAazd Research and Clinical Center for Infertility</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali avenue , Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>eftekhar@ssu.ac.ir</email>
        <affiliation>Yazd research and clinical center for infertility</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women  underwent previously  in vitro fertilization (IVF) or intra-cytoplasmicsperm   injection   (ICSI)   with   embryo   cryopreservation</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History  of  diabetes  mellitus
Thyroid  disease
Severe  endometriosis
Oocyte donation cycles
Women  with  age&gt;35 years
Body  mass  index  (BMI)&gt;30 kg/m2</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complication associated with artificial fertilization, unspecified</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>Intervention: Thawing is done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culture is done for 3 days until blastocyst development. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Transfer of embryos is done 3 days after thawing and thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound .</i_keyword>
      <i_keyword>Control: Thawing is done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transfered to uterine cavity 2 hours after thawing. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: Blood laboartory kit.</prim_outcome>
      <prim_outcome>Clinical pregnancy. Timepoint: 5 weeks after positive beta-hCG. Method of measurement: Observation of fetal heart activity by transvaginal ultrasonography.</prim_outcome>
      <prim_outcome>Ongoing pregnancy. Timepoint: 12 weeks after embryo transfer. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Miscarriage rate. Timepoint: Lost of pregnancy before 20 gestational week. Method of measurement: Absence of fetal heart activity in ultra sound 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>Yazd research and clinical center for infertility</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-19</approval_date>
        <contact_name>Yazd Research and Clinical Center for Infertility, Yazd University of Medical Sciences</contact_name>
        <contact_address>Safaeieh, Bouali Ave Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
