<?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>IRCT201210232575N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-24</date_registration>
      <primary_sponsor>Yazd  Shahid Sadoughi University of Medical Sciences and Health Services, Vice Chancellor for resear</primary_sponsor>
      <public_title>Effect of sildenafil citrate on endometrial preparation and on the outcome of the frozen-thawed embryo transfer cycles</public_title>
      <acronym></acronym>
      <scientific_title>Effect of sildenafil citrate on endometrial preparation and on the outcome of the frozen-thawed embryo transfer cycles in infertile women: a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Female Infertility.</hc_freetext>
      <i_freetext>Intervention 1: For group I start 2mg estradiol valerat (tablet)  from  first  to  4th  day  of  the  menstrual  cycle, and continue by 4mg from 5th  to  8th  day, and  6mg from 9th to 20th day of  the menstrual cycle. In 13th  day  of   the  menstrual  cycle  endometrial  thickness  estimated  with  transvaginal  ultrasonography  (arranged  in  a  series  every  other  day),  evaluations  were  performed  by  a  single  investigator,  if  the  endometrial  thickness  is  more  than  8mm,  100  mg  progesterone  injected  intramuscular  and  after  three  days  embryo was transferred. Estradiol  valerat  and  progesterone  continued  until   two  weeks  after  embryo  transferred,  then   BHCG  tested.  If  BHCG is positive,  estradiol  valerat  and  progesterone  continues  until  11  weeks  of  pregnancy .  Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound. Intervention 2: In the  group II in  addition  to  the  above  treatment  protocol,  from  first  day  of  cycle  until  the  day  of  starting  progesterone  will be given  50mg sildenafil citrate  tablets daily and  it  was  discontinued  between 48-72  hours  previous  of  the  embryo  transfer.  In 13th  day  of   the  menstrual  cycle  endometrial  thickness  estimated  with  transvaginal  ultrasonography  (arranged  in  a  series  every  other  day),  evaluations  were  performed  by  a  single  investigator,  if  the  endometrial  thickness  is  more  than  8mm,  100  mg  progesterone  injected  intramuscular  and  after  three  days  embryo was transferred. Estradiol  valerat  and  progesterone  continued  until   two  weeks  after  embryo  transferred,  then   BHCG  tested.  If  BHCG is positive,  estradiol  valerat  and  progesterone  continues  until  11  weeks  of  pregnancy .  Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Razieh Dehghani  Firouzabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>dr_firouzabai@ssu.ac.ir; pkhani55@gmail.com</email>
        <affiliation>Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Razieh Dehghani Firouzabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1825 7085</telephone>
        <email>dr_firouzabai@ssu.ac.ir, pkhani55@gmail.com</email>
        <affiliation>Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion  criteria:&#13;
All infertile women have high quality frozen embryos. &#13;
&#13;
Exclusion  criteria:&#13;
1. Age&gt; 40&#13;
2. History  of  endocrine  disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia&#13;
3. History  of  hysteroscopic  surgery due to intrauterine adhesions  &#13;
4. History of cardiovascular,  renal  or  liver  disease  &#13;
5. Hypotension(  blood  pressure&lt;90/50)  &#13;
6. History  of  stroke  or  myocardial  infarction&#13;
7. Poor quality embryos&#13;
8. Alcohol or Substance abuse</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Complications of attempted introduction of embryo in embryo transfer</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>For group I start 2mg estradiol valerat (tablet)  from  first  to  4th  day  of  the  menstrual  cycle, and continue by 4mg from 5th  to  8th  day, and  6mg from 9th to 20th day of  the menstrual cycle. In 13th  day  of   the  menstrual  cycle  endometrial  thickness  estimated  with  transvaginal  ultrasonography  (arranged  in  a  series  every  other  day),  evaluations  were  performed  by  a  single  investigator,  if  the  endometrial  thickness  is  more  than  8mm,  100  mg  progesterone  injected  intramuscular  and  after  three  days  embryo was transferred. Estradiol  valerat  and  progesterone  continued  until   two  weeks  after  embryo  transferred,  then   BHCG  tested.  If  BHCG is positive,  estradiol  valerat  and  progesterone  continues  until  11  weeks  of  pregnancy .  Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound.</i_keyword>
      <i_keyword>In the  group II in  addition  to  the  above  treatment  protocol,  from  first  day  of  cycle  until  the  day  of  starting  progesterone  will be given  50mg sildenafil citrate  tablets daily and  it  was  discontinued  between 48-72  hours  previous  of  the  embryo  transfer.  In 13th  day  of   the  menstrual  cycle  endometrial  thickness  estimated  with  transvaginal  ultrasonography  (arranged  in  a  series  every  other  day),  evaluations  were  performed  by  a  single  investigator,  if  the  endometrial  thickness  is  more  than  8mm,  100  mg  progesterone  injected  intramuscular  and  after  three  days  embryo was transferred. Estradiol  valerat  and  progesterone  continued  until   two  weeks  after  embryo  transferred,  then   BHCG  tested.  If  BHCG is positive,  estradiol  valerat  and  progesterone  continues  until  11  weeks  of  pregnancy .  Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endometrial thickness. Timepoint: ٌWithin a day from 13th  day  of   the  menstrual  cycle. Method of measurement: Vaginal sonoghraphy.</prim_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: BHCG test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of infertility. Timepoint: Before intervention. Method of measurement: Patient's medical record.</sec_outcome>
      <sec_outcome>Implantation rate. Timepoint: Four weeks after the embryo transfer. Method of measurement: Number of gestational sac are determined by vaginal ultrasound.</sec_outcome>
      <sec_outcome>FSH, LH, FSH/LH level. Timepoint: ratio  in progesterone day  administration. Method of measurement: Blood sample.</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  Shahid Sadoughi University of Medical Sciences and Health Services, Vice Chancellor for resear</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-03-10</approval_date>
        <contact_name>Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Bouali Ave., Safaeih, Research and Clinical Center for Infertility, Yazd, Iran. Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-22</approval_date>
        <contact_name>ٍEthics Committee of Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University o</contact_name>
        <contact_address>Bouali Ave., Safaeih, Research and Clinical Center for Infertility, Yazd, Iran. Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
