<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668446</url>
  </required_header>
  <id_info>
    <org_study_id>radvin123</org_study_id>
    <secondary_id>rad123</secondary_id>
    <secondary_id>rad123</secondary_id>
    <nct_id>NCT01668446</nct_id>
  </id_info>
  <brief_title>Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles</brief_title>
  <acronym>sildenafil</acronym>
  <official_title>Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>farzaneh hojjat</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Razieh dehghani firouzabadi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Robab davar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shahid Sadoughi University of Medical Sciences and Health Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The target of this study was an estimate the result of sildenafil on ultrasonographic&#xD;
      endometrial thickness, endometrial pattern investigation estrogen level on the day of&#xD;
      progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo&#xD;
      transfer cycles .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">September 2009</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>estimate the result of sildenafil on ultrasonographic endometrial thickness</measure>
    <time_frame>between 2009-2011 (up to 2 years)</time_frame>
    <description>Assays:&#xD;
Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .</measure>
    <time_frame>between 2009-2011 (up to 2 years)</time_frame>
    <description>Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Endometrial Preparation</condition>
  <condition>Frozen Embryo Transfer</condition>
  <arm_group>
    <arm_group_label>sildenafil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of two group to prepare the endometrium give estradiol by step up method with menstruation.&#xD;
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sildenafil and estradiol valerat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of two group to prepare the endometrium give estradiol by step up method with menstruation.&#xD;
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <description>sildenafil tablets(50 mg) daily</description>
    <arm_group_label>Sildenafil and estradiol valerat</arm_group_label>
    <arm_group_label>sildenafil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>estradiol valerat</intervention_name>
    <arm_group_label>Sildenafil and estradiol valerat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women &gt; 40 years old,&#xD;
&#xD;
          -  history of endocrine disease&#xD;
&#xD;
          -  Hysteroscopic surgery&#xD;
&#xD;
          -  cardiovascular, renal and liver disease&#xD;
&#xD;
          -  hypotension( blood pressure &lt; 90/50)&#xD;
&#xD;
          -  history of stroke or myocardial infarction&#xD;
&#xD;
          -  use of alcohol or substance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A total of 80 patients with antecedent of poor endometrial response and had frozen embryo&#xD;
        included in this study all women must to be &lt; 40 years old,&#xD;
&#xD;
          -  no history of endocrine disease,&#xD;
&#xD;
          -  no Hysteroscopic surgery, had a high quality embryos no cardiovascular,&#xD;
&#xD;
          -  renal and liver disease and&#xD;
&#xD;
          -  no hypotension (blood pressure &lt; 90/50) or&#xD;
&#xD;
          -  history of stroke or myocardial infarction and&#xD;
&#xD;
          -  don't use of alcohol or substance Patients with these conditions enter this study and&#xD;
             based on randomized tables are divided in two groups.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>farzaneh hojjat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Farzaneh Hojjat</name>
      <address>
        <city>Yazd</city>
        <zip>8916878466</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>June 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Sadoughi University of Medical Sciences and Health Services</investigator_affiliation>
    <investigator_full_name>farzaneh hojjat</investigator_full_name>
    <investigator_title>Farzaneh hojjat MD</investigator_title>
  </responsible_party>
  <keyword>Sildenafil</keyword>
  <keyword>Endometrial thickness</keyword>
  <keyword>Frozen embryo transfer</keyword>
  <keyword>ultrasonographic endometrial thickness</keyword>
  <keyword>endometrial pattern</keyword>
  <keyword>Implantation rate</keyword>
  <keyword>chemical pregnancy rate</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sildenafil Citrate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668446
org study id: radvin123
secondary id: rad123
secondary id: rad123
nct id: NCT01668446
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The target of this study was an estimate the result of sildenafil on ultrasonographic
      endometrial thickness, endometrial pattern investigation estrogen level on the day of
      progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo
      transfer cycles .
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: estimate the result of sildenafil on ultrasonographic endometrial thickness
time frame: between 2009-2011 (up to 2 years)
description: Assays:
Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.
measure: estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
time frame: between 2009-2011 (up to 2 years)
description: Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.
arm group label: sildenafil
arm group type: Experimental
description: One of two group to prepare the endometrium give estradiol by step up method with menstruation.
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.
arm group label: Sildenafil and estradiol valerat
arm group type: Experimental
description: One of two group to prepare the endometrium give estradiol by step up method with menstruation.
From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily.
intervention type: Drug
intervention name: Sildenafil
description: sildenafil tablets(50 mg) daily
arm group label: Sildenafil and estradiol valerat
arm group label: sildenafil
intervention type: Drug
intervention name: estradiol valerat
arm group label: Sildenafil and estradiol valerat
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: farzaneh hojjat, MD
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Shahid Sadoughi University of Medical Sciences and Health Services
investigator full name: farzaneh hojjat
investigator title: Farzaneh hojjat MD
mesh term: Sildenafil Citrate
mesh term: Estradiol