<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/NCT04501003</url>
  </required_header>
  <id_info>
    <org_study_id>E1/190/2019</org_study_id>
    <nct_id>NCT04501003</nct_id>
  </id_info>
  <brief_title>Investigation of U1-A Uterine Anomalies Implantation Markers From the Lateral Walls of the Endometrium</brief_title>
  <official_title>Investigation of Implantation Markers of Anomalies Classified as U1-A Uterine According to ESHRE/ESGE Classification of Female Genital Tractus Anomalies in Biopsy Specimens Obtained From the Lateral Walls of the Endometrium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ufuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ufuk 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>
      Various types and classes of uterine malformations have been identified and the ESHRE / ESGE&#xD;
      classification system has recently been published on female genital system anomalies.&#xD;
      Postoperative positive pregnancy results were obtained in studies conducted in patients with&#xD;
      infertility, recurrent implantation failure, and recurrent pregnancy loss, which were not&#xD;
      previously described in T-shaped uterine anomalies. Considering the increase in endometrial&#xD;
      gland and vascularity after the surgical procedure performed in these patients, our primary&#xD;
      goal in our study is to compare the number of implantation markers (αVβ3 integrin) and&#xD;
      subepithelial glands in the specimen biopsies taken from the lateral walls of the endometrium&#xD;
      before and after hysteroscopic surgery in patients with class U1a anomalies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2019</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.</measure>
    <time_frame>Baseline</time_frame>
    <description>From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>T-Shaped Uterus</condition>
  <condition>Infertility, Female</condition>
  <condition>Genital Tract Anomalies</condition>
  <arm_group>
    <arm_group_label>Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)</intervention_name>
    <description>With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm. The cavity was widened to be triangular and symmetrical. Both tubal ostium surgeries were clearly observed at the end of the surgery. All patients were discharged on the day of surgery and no hormonal therapy and intrauterine balloon was applied after surgery. Approximately 3 months after the hysteroscopic T-shaped operation, an office hysteroscopy operation was planned to control patients in the secretory phase, to perform uterine cavity and post-operative fly control and to receive post-operative control endometrial biopsy specimens.</description>
    <arm_group_label>Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-45 age,&#xD;
&#xD;
          2. Have no systemic disease,&#xD;
&#xD;
          3. ESGE U1-A having uterine anomaly,&#xD;
&#xD;
          4. Primary infertile, recurrent implantation loss, recurrent pregnancy loss history,&#xD;
&#xD;
          5. Not having previous uterine surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients over the age of 45 under the age of 18,&#xD;
&#xD;
          2. Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver&#xD;
             Disease, Epilepsy),&#xD;
&#xD;
          3. Having previous uterine surgery,&#xD;
&#xD;
          4. Those who gave birth.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sezin Oral Yıldız, M.D.</last_name>
    <phone>+905374459898</phone>
    <email>drsezinoral@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ufuk University</name>
      <address>
        <city>Ankara</city>
        <state>Çankaya</state>
        <zip>06520</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.</citation>
    <PMID>21705770</PMID>
  </reference>
  <reference>
    <citation>Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14.</citation>
    <PMID>23771171</PMID>
  </reference>
  <reference>
    <citation>Valle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta-analysis. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):22-42. doi: 10.1016/j.jmig.2012.09.010. Erratum In: J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):917-8.</citation>
    <PMID>23312243</PMID>
  </reference>
  <reference>
    <citation>Paradisi R, Barzanti R, Fabbri R. The techniques and outcomes of hysteroscopic metroplasty. Curr Opin Obstet Gynecol. 2014 Aug;26(4):295-301. doi: 10.1097/GCO.0000000000000077.</citation>
    <PMID>24978851</PMID>
  </reference>
  <reference>
    <citation>Giacomucci E, Bellavia E, Sandri F, Farina A, Scagliarini G. Term delivery rate after hysteroscopic metroplasty in patients with recurrent spontaneous abortion and T-shaped, arcuate and septate uterus. Gynecol Obstet Invest. 2011;71(3):183-8. doi: 10.1159/000317266. Epub 2010 Dec 11.</citation>
    <PMID>21150155</PMID>
  </reference>
  <reference>
    <citation>Fox NS, Roman AS, Stern EM, Gerber RS, Saltzman DH, Rebarber A. Type of congenital uterine anomaly and adverse pregnancy outcomes. J Matern Fetal Neonatal Med. 2014 Jun;27(9):949-53. doi: 10.3109/14767058.2013.847082. Epub 2013 Nov 26.</citation>
    <PMID>24050215</PMID>
  </reference>
  <reference>
    <citation>Bendifallah S, Faivre E, Legendre G, Deffieux X, Fernandez H. Metroplasty for AFS Class V and VI septate uterus in patients with infertility or miscarriage: reproductive outcomes study. J Minim Invasive Gynecol. 2013 Mar-Apr;20(2):178-84. doi: 10.1016/j.jmig.2012.11.002. Epub 2013 Jan 11.</citation>
    <PMID>23317507</PMID>
  </reference>
  <reference>
    <citation>Kaufman RH, Binder GL, Gray PM Jr, Adam E. Upper genital tract changes associated with exposure in utero to diethylstilbestrol. Am J Obstet Gynecol. 1977 May 1;128(1):51-9. doi: 10.1016/0002-9378(77)90294-0.</citation>
    <PMID>851159</PMID>
  </reference>
  <reference>
    <citation>Katz Z, Ben-Arie A, Lurie S, Manor M, Insler V. Beneficial effect of hysteroscopic metroplasty on the reproductive outcome in a 'T-shaped' uterus. Gynecol Obstet Invest. 1996;41(1):41-3. doi: 10.1159/000292033.</citation>
    <PMID>8821883</PMID>
  </reference>
  <reference>
    <citation>Garbin O, Ohl J, Bettahar-Lebugle K, Dellenbach P. Hysteroscopic metroplasty in diethylstilboestrol-exposed and hypoplastic uterus: a report on 24 cases. Hum Reprod. 1998 Oct;13(1O):2751-5. doi: 10.1093/humrep/13.10.2751.</citation>
    <PMID>9804225</PMID>
  </reference>
  <reference>
    <citation>Barranger E, Gervaise A, Doumerc S, Fernandez H. Reproductive performance after hysteroscopic metroplasty in the hypoplastic uterus: a study of 29 cases. BJOG. 2002 Dec;109(12):1331-4. doi: 10.1046/j.1471-0528.2002.01448.x.</citation>
    <PMID>12504966</PMID>
  </reference>
  <reference>
    <citation>de los Santos MJ, Mercader A, Galan A, Albert C, Romero JL, Pellicer A. Implantation rates after two, three, or five days of embryo culture. Placenta. 2003 Oct;24 Suppl B:S13-9. doi: 10.1016/s0143-4004(03)00172-3.</citation>
    <PMID>14559025</PMID>
  </reference>
  <reference>
    <citation>Tan BK, Vandekerckhove P, Kennedy R, Keay SD. Investigation and current management of recurrent IVF treatment failure in the UK. BJOG. 2005 Jun;112(6):773-80. doi: 10.1111/j.1471-0528.2005.00523.x.</citation>
    <PMID>15924536</PMID>
  </reference>
  <reference>
    <citation>Urman B, Yakin K, Balaban B. Recurrent implantation failure in assisted reproduction: how to counsel and manage. A. General considerations and treatment options that may benefit the couple. Reprod Biomed Online. 2005 Sep;11(3):371-81. doi: 10.1016/s1472-6483(10)60846-2.</citation>
    <PMID>16176681</PMID>
  </reference>
  <reference>
    <citation>Aflatoonian A, Baradaran Bagheri R, Hosseinisadat R. The effect of endometrial injury on pregnancy rate in frozen-thawed embryo transfer: A randomized control trial. Int J Reprod Biomed. 2016 Jul;14(7):453-158. Erratum In: Int J Reprod Biomed. 2022 Apr 21;20(3):231-232.</citation>
    <PMID>27525329</PMID>
  </reference>
  <reference>
    <citation>Dey SK, Lim H, Das SK, Reese J, Paria BC, Daikoku T, Wang H. Molecular cues to implantation. Endocr Rev. 2004 Jun;25(3):341-73. doi: 10.1210/er.2003-0020.</citation>
    <PMID>15180948</PMID>
  </reference>
  <reference>
    <citation>Lessey BA. Two pathways of progesterone action in the human endometrium: implications for implantation and contraception. Steroids. 2003 Nov;68(10-13):809-15. doi: 10.1016/j.steroids.2003.09.004.</citation>
    <PMID>14667972</PMID>
  </reference>
  <reference>
    <citation>Achache H, Revel A. Endometrial receptivity markers, the journey to successful embryo implantation. Hum Reprod Update. 2006 Nov-Dec;12(6):731-46. doi: 10.1093/humupd/dml004. Epub 2006 Sep 18.</citation>
    <PMID>16982667</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ufuk University</investigator_affiliation>
    <investigator_full_name>Sezin Oral Yıldız</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>T-Shaped Uterus</keyword>
  <keyword>Infertility, Female</keyword>
  <keyword>Intregrin Beta 3</keyword>
  <keyword>Genital Tract Anomalies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_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/NCT04501003
org study id: E1/190/2019
nct id: NCT04501003
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Various types and classes of uterine malformations have been identified and the ESHRE / ESGE
      classification system has recently been published on female genital system anomalies.
      Postoperative positive pregnancy results were obtained in studies conducted in patients with
      infertility, recurrent implantation failure, and recurrent pregnancy loss, which were not
      previously described in T-shaped uterine anomalies. Considering the increase in endometrial
      gland and vascularity after the surgical procedure performed in these patients, our primary
      goal in our study is to compare the number of implantation markers (αVβ3 integrin) and
      subepithelial glands in the specimen biopsies taken from the lateral walls of the endometrium
      before and after hysteroscopic surgery in patients with class U1a anomalies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.
time frame: Baseline
description: From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.
arm group label: Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
arm group type: Other
description: With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm.
intervention type: Device
intervention name: Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
description: With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm. The cavity was widened to be triangular and symmetrical. Both tubal ostium surgeries were clearly observed at the end of the surgery. All patients were discharged on the day of surgery and no hormonal therapy and intrauterine balloon was applied after surgery. Approximately 3 months after the hysteroscopic T-shaped operation, an office hysteroscopy operation was planned to control patients in the secretory phase, to perform uterine cavity and post-operative fly control and to receive post-operative control endometrial biopsy specimens.
arm group label: Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sezin Oral Yıldız, M.D.
phone: +905374459898
email: drsezinoral@gmail.com
facility: 
status: Recruiting
country: Turkey
citation: Chan YY, Jayaprakasan K, Zamora J, Thornton JG, Raine-Fenning N, Coomarasamy A. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):761-71. doi: 10.1093/humupd/dmr028. Epub 2011 Jun 24.
PMID: 21705770
citation: Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14.
PMID: 23771171
citation: Valle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta-analysis. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):22-42. doi: 10.1016/j.jmig.2012.09.010. Erratum In: J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):917-8.
PMID: 23312243
citation: Paradisi R, Barzanti R, Fabbri R. The techniques and outcomes of hysteroscopic metroplasty. Curr Opin Obstet Gynecol. 2014 Aug;26(4):295-301. doi: 10.1097/GCO.0000000000000077.
PMID: 24978851
citation: Giacomucci E, Bellavia E, Sandri F, Farina A, Scagliarini G. Term delivery rate after hysteroscopic metroplasty in patients with recurrent spontaneous abortion and T-shaped, arcuate and septate uterus. Gynecol Obstet Invest. 2011;71(3):183-8. doi: 10.1159/000317266. Epub 2010 Dec 11.
PMID: 21150155
citation: Fox NS, Roman AS, Stern EM, Gerber RS, Saltzman DH, Rebarber A. Type of congenital uterine anomaly and adverse pregnancy outcomes. J Matern Fetal Neonatal Med. 2014 Jun;27(9):949-53. doi: 10.3109/14767058.2013.847082. Epub 2013 Nov 26.
PMID: 24050215
citation: Bendifallah S, Faivre E, Legendre G, Deffieux X, Fernandez H. Metroplasty for AFS Class V and VI septate uterus in patients with infertility or miscarriage: reproductive outcomes study. J Minim Invasive Gynecol. 2013 Mar-Apr;20(2):178-84. doi: 10.1016/j.jmig.2012.11.002. Epub 2013 Jan 11.
PMID: 23317507
citation: Kaufman RH, Binder GL, Gray PM Jr, Adam E. Upper genital tract changes associated with exposure in utero to diethylstilbestrol. Am J Obstet Gynecol. 1977 May 1;128(1):51-9. doi: 10.1016/0002-9378(77)90294-0.
PMID: 851159
citation: Katz Z, Ben-Arie A, Lurie S, Manor M, Insler V. Beneficial effect of hysteroscopic metroplasty on the reproductive outcome in a 'T-shaped' uterus. Gynecol Obstet Invest. 1996;41(1):41-3. doi: 10.1159/000292033.
PMID: 8821883
citation: Garbin O, Ohl J, Bettahar-Lebugle K, Dellenbach P. Hysteroscopic metroplasty in diethylstilboestrol-exposed and hypoplastic uterus: a report on 24 cases. Hum Reprod. 1998 Oct;13(1O):2751-5. doi: 10.1093/humrep/13.10.2751.
PMID: 9804225
citation: Barranger E, Gervaise A, Doumerc S, Fernandez H. Reproductive performance after hysteroscopic metroplasty in the hypoplastic uterus: a study of 29 cases. BJOG. 2002 Dec;109(12):1331-4. doi: 10.1046/j.1471-0528.2002.01448.x.
PMID: 12504966
citation: de los Santos MJ, Mercader A, Galan A, Albert C, Romero JL, Pellicer A. Implantation rates after two, three, or five days of embryo culture. Placenta. 2003 Oct;24 Suppl B:S13-9. doi: 10.1016/s0143-4004(03)00172-3.
PMID: 14559025
citation: Tan BK, Vandekerckhove P, Kennedy R, Keay SD. Investigation and current management of recurrent IVF treatment failure in the UK. BJOG. 2005 Jun;112(6):773-80. doi: 10.1111/j.1471-0528.2005.00523.x.
PMID: 15924536
citation: Urman B, Yakin K, Balaban B. Recurrent implantation failure in assisted reproduction: how to counsel and manage. A. General considerations and treatment options that may benefit the couple. Reprod Biomed Online. 2005 Sep;11(3):371-81. doi: 10.1016/s1472-6483(10)60846-2.
PMID: 16176681
citation: Aflatoonian A, Baradaran Bagheri R, Hosseinisadat R. The effect of endometrial injury on pregnancy rate in frozen-thawed embryo transfer: A randomized control trial. Int J Reprod Biomed. 2016 Jul;14(7):453-158. Erratum In: Int J Reprod Biomed. 2022 Apr 21;20(3):231-232.
PMID: 27525329
citation: Dey SK, Lim H, Das SK, Reese J, Paria BC, Daikoku T, Wang H. Molecular cues to implantation. Endocr Rev. 2004 Jun;25(3):341-73. doi: 10.1210/er.2003-0020.
PMID: 15180948
citation: Lessey BA. Two pathways of progesterone action in the human endometrium: implications for implantation and contraception. Steroids. 2003 Nov;68(10-13):809-15. doi: 10.1016/j.steroids.2003.09.004.
PMID: 14667972
citation: Achache H, Revel A. Endometrial receptivity markers, the journey to successful embryo implantation. Hum Reprod Update. 2006 Nov-Dec;12(6):731-46. doi: 10.1093/humupd/dml004. Epub 2006 Sep 18.
PMID: 16982667
responsible party type: Principal Investigator
investigator affiliation: Ufuk University
investigator full name: Sezin Oral Yıldız
investigator title: Resident
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Congenital Abnormalities