<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/NCT04424160</url>
  </required_header>
  <id_info>
    <org_study_id>KA20/23</org_study_id>
    <nct_id>NCT04424160</nct_id>
  </id_info>
  <brief_title>Effects of Platelet Rich Plasma on Endometrium</brief_title>
  <official_title>Effects of Intrauterine Platelet Rich Plasma (PRP) on Endometrium and Pregnancy Rates in Patients With Suboptimal Endometrium Undergoing Frozen Embryo Transfer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Acibadem University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal&#xD;
      route after the cessation of menstrual period. The endometrial thickness will be assessed&#xD;
      under ultrasound and hormone replacement will be started. As the endometrial thickness&#xD;
      reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal&#xD;
      route after the cessation of menstrual period. In the second menstrual period following the&#xD;
      PRP injection, the endometrial thickness will be assessed under ultrasound and hormone&#xD;
      replacement will be started. As the endometrial thickness reaches adequate thickness during&#xD;
      ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be&#xD;
      recorded and followed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">April 19, 2021</completion_date>
  <primary_completion_date type="Actual">April 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day. On the second menstrual cycle after the procedure, the patients will be checked under ultrasound and will be started hormone replacement therapy for embryo transfer.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endometrial thickness during hormone replacement therapy</measure>
    <time_frame>2-10 months</time_frame>
    <description>To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy outcomes after frozen-thawed embryo transfer</measure>
    <time_frame>2-10 months</time_frame>
    <description>To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Asherman Syndrome</condition>
  <arm_group>
    <arm_group_label>Endometrial PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in whom endometrial PRP was performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP injection in the endometrium</intervention_name>
    <description>Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.</description>
    <arm_group_label>Endometrial PRP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in whom cycle was cancelled due to an endometrial thickness &lt;7 mm when&#xD;
             progesterone start was planned in patients undergoing frozen embryo transfer with&#xD;
             hormone replacement therapy&#xD;
&#xD;
          -  Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the&#xD;
             last hysteroscopic procedure;&#xD;
&#xD;
          -  Women who have at least 2 frozen good-quality embryos.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with any other known cause of implantation failure, such as poor embryo quality,&#xD;
             or congenital uterine anomalies, endometrial polyp or fibroid,&#xD;
&#xD;
          -  Previous diagnosis of any malignancy,&#xD;
&#xD;
          -  Anticoagulant use for which plasma infusion is contraindicated,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All infertile women desiring pregnancy</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hulusi Bulent Zeyneloglu, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baskent University Departments of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yigit Cakiroglu, Assoc.Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Acibadem University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Acıbadem Maslak Hospital IVF Unit</name>
      <address>
        <city>Istanbul</city>
        <zip>34460</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.</citation>
    <PMID>25785127</PMID>
  </results_reference>
  <results_reference>
    <citation>Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.</citation>
    <PMID>29142450</PMID>
  </results_reference>
  <results_reference>
    <citation>Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.</citation>
    <PMID>28333034</PMID>
  </results_reference>
  <results_reference>
    <citation>Chang Y, Li J, Wei LN, Pang J, Chen J, Liang X. Autologous platelet-rich plasma infusion improves clinical pregnancy rate in frozen embryo transfer cycles for women with thin endometrium. Medicine (Baltimore). 2019 Jan;98(3):e14062. doi: 10.1097/MD.0000000000014062.</citation>
    <PMID>30653117</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Bulent Tiras</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gynatresia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04424160
org study id: KA20/23
nct id: NCT04424160
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal
      route after the cessation of menstrual period. The endometrial thickness will be assessed
      under ultrasound and hormone replacement will be started. As the endometrial thickness
      reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.
Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal
      route after the cessation of menstrual period. In the second menstrual period following the
      PRP injection, the endometrial thickness will be assessed under ultrasound and hormone
      replacement will be started. As the endometrial thickness reaches adequate thickness during
      ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be
      recorded and followed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day. On the second menstrual cycle after the procedure, the patients will be checked under ultrasound and will be started hormone replacement therapy for embryo transfer.
primary purpose: Treatment
masking: None (Open Label)
measure: Endometrial thickness during hormone replacement therapy
time frame: 2-10 months
description: To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles
measure: Pregnancy outcomes after frozen-thawed embryo transfer
time frame: 2-10 months
description: To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles
arm group label: Endometrial PRP
arm group type: Experimental
description: Patients in whom endometrial PRP was performed
intervention type: Biological
intervention name: PRP injection in the endometrium
description: Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.
arm group label: Endometrial PRP
criteria: 
gender: Female
gender based: Yes
gender description: All infertile women desiring pregnancy
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Hulusi Bulent Zeyneloglu, Prof
role: Principal Investigator
affiliation: Baskent University Departments of Obstetrics and Gynecology
last name: Yigit Cakiroglu, Assoc.Prof.
role: Study Director
affiliation: Acibadem University
facility: 
country: Turkey
citation: Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015.
PMID: 25785127
citation: Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.
PMID: 29142450
citation: Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.
PMID: 28333034
citation: Chang Y, Li J, Wei LN, Pang J, Chen J, Liang X. Autologous platelet-rich plasma infusion improves clinical pregnancy rate in frozen embryo transfer cycles for women with thin endometrium. Medicine (Baltimore). 2019 Jan;98(3):e14062. doi: 10.1097/MD.0000000000014062.
PMID: 30653117
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Bulent Tiras
investigator title: Prof.
mesh term: Gynatresia
sharing ipd: No