xml: <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/NCT05971667</url>
    </required_header>
    <id_info>
      <org_study_id>Tadalafil IVF</org_study_id>
      <nct_id>NCT05971667</nct_id>
    </id_info>
    <brief_title>Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes</brief_title>
    <official_title>&quot;Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to investigate the Effect of different vasodilators as Tadalafil,&#xD;
        Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of&#xD;
        endometrium and pregnancies rates of these women will also be examined. All adverse effects&#xD;
        of all drugs will be estimated&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology&#xD;
        department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients&#xD;
        will be randomized into four groups.&#xD;
  &#xD;
        The participants will take drugs starting from the end of menstruation cycle till endometrium&#xD;
        reach optimal and then will start progesterone 800 mg daily.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>endometrial thickness</measure>
      <time_frame>within 16 day of menstruation</time_frame>
      <description>measured by transvaginal ultrasound</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>pregnancy rate</measure>
      <time_frame>1 month</time_frame>
      <description>number of cases positive serum pregnancy test</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>IVF</condition>
    <arm_group>
      <arm_group_label>tadalafil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>tadalafil 10 mg one tablet daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>pentoxifylline</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>pentoxyfilline 400 mg two tabs daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sildenafil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>sildenafil 20 mg two tablets</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no intervention is given</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>tadalafil</intervention_name>
      <description>tadalafil 10 mg one tablet daily</description>
      <arm_group_label>tadalafil</arm_group_label>
      <other_name>cialong</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sildenafil</intervention_name>
      <description>sildenafil 20 mg two tablets daily</description>
      <arm_group_label>sildenafil</arm_group_label>
      <other_name>Respatio</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pentoxifylline</intervention_name>
      <description>pentoxifylline 400 mg two tabs daily</description>
      <arm_group_label>pentoxifylline</arm_group_label>
      <other_name>trental</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  women having thawed embryos&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  hypotension&#xD;
  &#xD;
            -  cardiovascular, hepatic, and renal diseases;&#xD;
  &#xD;
            -  uncontrolled diabetes mellitus;&#xD;
  &#xD;
            -  ovarian cysts;&#xD;
  &#xD;
            -  hyperprolactinemia;&#xD;
  &#xD;
            -  abnormal thyroid functions;&#xD;
  &#xD;
            -  uterine fibroids;&#xD;
  &#xD;
            -  patients taking nitrates;&#xD;
  &#xD;
            -  endometriosis and adenomyosis&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>Tadalafil</keyword>
    <keyword>Sildenafil</keyword>
    <keyword>pentoxyfylline</keyword>
    <keyword>frozen embryo transfer</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sildenafil Citrate</mesh_term>
      <mesh_term>Tadalafil</mesh_term>
      <mesh_term>Pentoxifylline</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971667
  org study id: Tadalafil IVF
  nct id: NCT05971667
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the Effect of different vasodilators as Tadalafil,
        Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of
        endometrium and pregnancies rates of these women will also be examined. All adverse effects
        of all drugs will be estimated
  A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology
        department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients
        will be randomized into four groups.
  
        The participants will take drugs starting from the end of menstruation cycle till endometrium
        reach optimal and then will start progesterone 800 mg daily.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: endometrial thickness
  time frame: within 16 day of menstruation
  description: measured by transvaginal ultrasound
  measure: pregnancy rate
  time frame: 1 month
  description: number of cases positive serum pregnancy test
  arm group label: tadalafil
  arm group type: Experimental
  description: tadalafil 10 mg one tablet daily
  arm group label: pentoxifylline
  arm group type: Experimental
  description: pentoxyfilline 400 mg two tabs daily
  arm group label: sildenafil
  arm group type: Experimental
  description: sildenafil 20 mg two tablets
  arm group label: control group.
  arm group type: No Intervention
  description: no intervention is given
  intervention type: Drug
  intervention name: tadalafil
  description: tadalafil 10 mg one tablet daily
  arm group label: tadalafil
  other name: cialong
  intervention type: Drug
  intervention name: Sildenafil
  description: sildenafil 20 mg two tablets daily
  arm group label: sildenafil
  other name: Respatio
  intervention type: Drug
  intervention name: pentoxifylline
  description: pentoxifylline 400 mg two tabs daily
  arm group label: pentoxifylline
  other name: trental
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Sildenafil Citrate
  mesh term: Tadalafil
  mesh term: Pentoxifylline
  sharing ipd: Undecided