<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/NCT03828786</url>
  </required_header>
  <id_info>
    <org_study_id>ovo-18-01</org_study_id>
    <nct_id>NCT03828786</nct_id>
  </id_info>
  <brief_title>Uterine Scratching in Intra-Uterine Insemination</brief_title>
  <official_title>The Impact of Uterine Scratching Prior to Intra-Uterine Insemination in Unexplained Infertility, a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Ovo</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>
      This study will evaluate the potential benefits of uterine injury during the follicular phase&#xD;
      of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first&#xD;
      trimester ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infertility is defined as the absence of conception after a year of unprotected intercourse.&#xD;
      In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in&#xD;
      unexplained infertility has been to cause a uterine trauma prior to treatment. This is done&#xD;
      by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF&#xD;
      and has been shown beneficial. Theoretically, the uterine scratching could increase the&#xD;
      immune response and the vascularization of the endometrium which could help in embryo&#xD;
      implantation. However, there is very few data concerning scratching in intrauterine&#xD;
      insemination. The studies are mostly small studies and the results are often contradictory.&#xD;
      In this randomized controlled trial, the investigators will evaluate the effect of uterine&#xD;
      scratching during the follicular phase of an insemination cycle on the pregnancy rate of a&#xD;
      large cohort of unexplained infertile couples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2018</start_date>
  <completion_date type="Anticipated">March 30, 2024</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy - Pregnancy Rate measured during the first trimester ultrasound.</measure>
    <time_frame>13 weeks</time_frame>
    <description>Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy - Secondary pregnancy rate.</measure>
    <time_frame>6 months</time_frame>
    <description>Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety - Side effects</measure>
    <time_frame>6 months for all 3 intrauterine insemination</time_frame>
    <description>Evaluate side effects related to the intrauterine scratching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety - Complications</measure>
    <time_frame>6 months for all 3 intrauterine insemination</time_frame>
    <description>Evaluate complications related to intrauterine scratching</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">394</enrollment>
  <condition>Infertility</condition>
  <condition>Unexplained Infertility</condition>
  <arm_group>
    <arm_group_label>Endometrial scratching group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endometrial scratching will be done with a Pipelle in uterus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endometrial scratching</intervention_name>
    <description>Endometrial Biopsy by aspiration with a pipelle</description>
    <arm_group_label>Endometrial scratching group</arm_group_label>
    <other_name>Endometrial Biopsy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unexplained infertility for over 12 months if under 35 years old or over 6 months if&#xD;
             35 years old and above.&#xD;
&#xD;
          -  At least one permeable tube on hysterosonography or hysterosalpingography within the&#xD;
             last 2 years or vaginal delivery in the last 3 years.&#xD;
&#xD;
          -  Antral follicular count over 5.&#xD;
&#xD;
          -  Normal or mild male factor.&#xD;
&#xD;
          -  Normal uterine cavity.&#xD;
&#xD;
          -  An IUI prescription.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Polycystic ovary syndrome with irregular menstrual cycles over 45 days&#xD;
&#xD;
          -  Severe endometriosis&#xD;
&#xD;
          -  IUI with Donor sperm&#xD;
&#xD;
          -  Patient with invasive intra-uterine procedure in the last 3 months.&#xD;
&#xD;
          -  Contraindication to endometrial biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women of reproductive age</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>41 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louise Lapensee, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Ovo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Ovo</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.</citation>
    <PMID>17681303</PMID>
  </reference>
  <reference>
    <citation>Wadhwa L, Pritam A, Gupta T, Gupta S, Arora S, Chandoke R. Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle. J Hum Reprod Sci. 2015 Jul-Sep;8(3):151-8. doi: 10.4103/0974-1208.165144.</citation>
    <PMID>26538858</PMID>
  </reference>
  <reference>
    <citation>Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.</citation>
    <PMID>17197286</PMID>
  </reference>
  <reference>
    <citation>Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.</citation>
    <PMID>23095139</PMID>
  </reference>
  <reference>
    <citation>Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.</citation>
    <PMID>22786529</PMID>
  </reference>
  <reference>
    <citation>Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.</citation>
    <PMID>20607003</PMID>
  </reference>
  <reference>
    <citation>Maged AM, Al-Inany H, Salama KM, Souidan II, Abo Ragab HM, Elnassery N. Endometrial Scratch Injury Induces Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation: A Randomized Controlled Trial. Reprod Sci. 2016 Feb;23(2):239-43. doi: 10.1177/1933719115602776. Epub 2015 Sep 3.</citation>
    <PMID>26342054</PMID>
  </reference>
  <reference>
    <citation>Lensen SF, Manders M, Nastri CO, Gibreel A, Martins WP, Templer GE, Farquhar C. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD011424. doi: 10.1002/14651858.CD011424.pub2.</citation>
    <PMID>27296541</PMID>
  </reference>
  <reference>
    <citation>Lensen S, Sadler L, Farquhar C. Endometrial scratching for subfertility: everyone's doing it. Hum Reprod. 2016 Jun;31(6):1241-4. doi: 10.1093/humrep/dew053. Epub 2016 Mar 22.</citation>
    <PMID>27008891</PMID>
  </reference>
  <reference>
    <citation>Ledee N, Petitbarat M, Chevrier L, Vitoux D, Vezmar K, Rahmati M, Dubanchet S, Gahery H, Bensussan A, Chaouat G. The Uterine Immune Profile May Help Women With Repeated Unexplained Embryo Implantation Failure After In Vitro Fertilization. Am J Reprod Immunol. 2016 Mar;75(3):388-401. doi: 10.1111/aji.12483. Epub 2016 Jan 18.</citation>
    <PMID>26777262</PMID>
  </reference>
  <reference>
    <citation>Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.</citation>
    <PMID>20070722</PMID>
  </reference>
  <reference>
    <citation>Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29. Erratum In: J Obstet Gynaecol Res. 2021 Aug;47(8):2936.</citation>
    <PMID>23106834</PMID>
  </reference>
  <reference>
    <citation>Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.</citation>
    <PMID>5050152</PMID>
  </reference>
  <reference>
    <citation>Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.</citation>
    <PMID>12798877</PMID>
  </reference>
  <reference>
    <citation>Bahaa Eldin AM, Abdelmaabud KH, Laban M, Hassanin AS, Tharwat AA, Aly TR, Elbohoty AE, Elsayed HM, Ibrahim AM, Ibrahim ME, Sabaa HM, Abdelrazik AA, Abdelhady I. Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial. Reprod Sci. 2016 Oct;23(10):1326-31. doi: 10.1177/1933719116638191. Epub 2016 May 4.</citation>
    <PMID>27146582</PMID>
  </reference>
  <reference>
    <citation>Abdelhamid AM. The success rate of pregnancy in IUI cycles following endometrial sampling. A randomized controlled study: endometrial sampling and pregnancy rates. Arch Gynecol Obstet. 2013 Sep;288(3):673-8. doi: 10.1007/s00404-013-2785-0. Epub 2013 Mar 15.</citation>
    <PMID>23494199</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intra-uterine insemination</keyword>
  <keyword>endometrial injury</keyword>
  <keyword>scratching</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT03828786
org study id: ovo-18-01
nct id: NCT03828786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the potential benefits of uterine injury during the follicular phase
      of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first
      trimester ultrasound.
Infertility is defined as the absence of conception after a year of unprotected intercourse.
      In 10 to 30 % of patients, the cause of the infertility is unknown. An emerging practice in
      unexplained infertility has been to cause a uterine trauma prior to treatment. This is done
      by doing a small endometrial scratch with a pipelle. This intervention has been study in IVF
      and has been shown beneficial. Theoretically, the uterine scratching could increase the
      immune response and the vascularization of the endometrium which could help in embryo
      implantation. However, there is very few data concerning scratching in intrauterine
      insemination. The studies are mostly small studies and the results are often contradictory.
      In this randomized controlled trial, the investigators will evaluate the effect of uterine
      scratching during the follicular phase of an insemination cycle on the pregnancy rate of a
      large cohort of unexplained infertile couples.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
time frame: 13 weeks
description: Ongoing pregnancy during the first trimester ultrasound after an intrauterine insemination (IUI) cycle.
measure: Efficacy - Secondary pregnancy rate.
time frame: 6 months
description: Ongoing pregnancy during the first trimester ultrasound in the 3 IUI cycles following a scratching
measure: Safety - Side effects
time frame: 6 months for all 3 intrauterine insemination
description: Evaluate side effects related to the intrauterine scratching
measure: Safety - Complications
time frame: 6 months for all 3 intrauterine insemination
description: Evaluate complications related to intrauterine scratching
arm group label: Endometrial scratching group
arm group type: Active Comparator
description: Endometrial scratching will be done with a Pipelle in uterus.
arm group label: Control group
arm group type: No Intervention
description: This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure
intervention type: Procedure
intervention name: Endometrial scratching
description: Endometrial Biopsy by aspiration with a pipelle
arm group label: Endometrial scratching group
other name: Endometrial Biopsy
criteria: 
gender: Female
gender based: Yes
gender description: Women of reproductive age
minimum age: 18 Years
maximum age: 41 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Louise Lapensee, Md
role: Principal Investigator
affiliation: Clinique Ovo
facility: 
country: Canada
citation: Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.
PMID: 17681303
citation: Wadhwa L, Pritam A, Gupta T, Gupta S, Arora S, Chandoke R. Effect of endometrial biopsy on intrauterine insemination outcome in controlled ovarian stimulation cycle. J Hum Reprod Sci. 2015 Jul-Sep;8(3):151-8. doi: 10.4103/0974-1208.165144.
PMID: 26538858
citation: Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.
PMID: 17197286
citation: Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.
PMID: 23095139
citation: Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.
PMID: 22786529
citation: Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.
PMID: 20607003
citation: Maged AM, Al-Inany H, Salama KM, Souidan II, Abo Ragab HM, Elnassery N. Endometrial Scratch Injury Induces Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation: A Randomized Controlled Trial. Reprod Sci. 2016 Feb;23(2):239-43. doi: 10.1177/1933719115602776. Epub 2015 Sep 3.
PMID: 26342054
citation: Lensen SF, Manders M, Nastri CO, Gibreel A, Martins WP, Templer GE, Farquhar C. Endometrial injury for pregnancy following sexual intercourse or intrauterine insemination. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD011424. doi: 10.1002/14651858.CD011424.pub2.
PMID: 27296541
citation: Lensen S, Sadler L, Farquhar C. Endometrial scratching for subfertility: everyone's doing it. Hum Reprod. 2016 Jun;31(6):1241-4. doi: 10.1093/humrep/dew053. Epub 2016 Mar 22.
PMID: 27008891
citation: Ledee N, Petitbarat M, Chevrier L, Vitoux D, Vezmar K, Rahmati M, Dubanchet S, Gahery H, Bensussan A, Chaouat G. The Uterine Immune Profile May Help Women With Repeated Unexplained Embryo Implantation Failure After In Vitro Fertilization. Am J Reprod Immunol. 2016 Mar;75(3):388-401. doi: 10.1111/aji.12483. Epub 2016 Jan 18.
PMID: 26777262
citation: Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.
PMID: 20070722
citation: Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29. Erratum In: J Obstet Gynaecol Res. 2021 Aug;47(8):2936.
PMID: 23106834
citation: Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.
PMID: 5050152
citation: Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PMID: 12798877
citation: Bahaa Eldin AM, Abdelmaabud KH, Laban M, Hassanin AS, Tharwat AA, Aly TR, Elbohoty AE, Elsayed HM, Ibrahim AM, Ibrahim ME, Sabaa HM, Abdelrazik AA, Abdelhady I. Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination: An Interventional Randomized Clinical Trial. Reprod Sci. 2016 Oct;23(10):1326-31. doi: 10.1177/1933719116638191. Epub 2016 May 4.
PMID: 27146582
citation: Abdelhamid AM. The success rate of pregnancy in IUI cycles following endometrial sampling. A randomized controlled study: endometrial sampling and pregnancy rates. Arch Gynecol Obstet. 2013 Sep;288(3):673-8. doi: 10.1007/s00404-013-2785-0. Epub 2013 Mar 15.
PMID: 23494199
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No