<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/NCT03282279</url>
  </required_header>
  <id_info>
    <org_study_id>17/17</org_study_id>
    <nct_id>NCT03282279</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).</brief_title>
  <acronym>TVOR</acronym>
  <official_title>Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators retrospectively analysed the complication rate of ultrasound guided&#xD;
      transvaginal oocyte retrieval (TVOR) from all the procedures performed between 1996 and&#xD;
      October 2016 in a tertiary level university based fertility clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound guided transvaginal oocyte retrieval (TVOR) is nowadays gold standard techniques&#xD;
      to collect oocyte after ovulation induction in Assisted Reproductive techniques (ART). It is&#xD;
      a very safe technique with infectious complications of any kind occurring in just 1% (Bennett&#xD;
      et al.) of all procedures, vaginal bleeding in 0 to 1.3% of the procedures (Ludwig et al.,&#xD;
      Bodri et al., Aragona et al.) and vascular, gastrointestinal and genitourinary (Grynberg et&#xD;
      al. and Catanzarite and al.), injuries being extremely rare (Bennett et al.). Case reports&#xD;
      account also for rarer complications such as ovarian abscess formation (Kelada &amp; Ghan and&#xD;
      Sharp et al.) pseudoanerysm formation (Bozdag et al. and Jayakrishnan et al.),&#xD;
      uroretroperitoneum (Fiori et al.).&#xD;
&#xD;
      The rational of thestudy is to provide the percentages of complication from TVOR of the&#xD;
      Fertility Center of Humanitas Research Hospital, also considering the development in time of&#xD;
      technologies and techniques in Assisted Reproduction. Another rational is inquire whether&#xD;
      there is any risk factor for such complications in order to try to prevent them in future&#xD;
      procedures. The investigators performed a retrospective observational study including all the&#xD;
      transvaginal oocyte retrieval procedures performed between 1996 and October 2016.&#xD;
&#xD;
      The data have been collected from the Humanitas Fertility Center' Department database&#xD;
      (ART.it). Because of the retrospective nature of this study, a specific informed consent was&#xD;
      not necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 1996</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>complications rate</measure>
    <time_frame>20 years</time_frame>
    <description>number of oocyte retrieval complications reported / number of procedures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalisation rate</measure>
    <time_frame>20 years</time_frame>
    <description>number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23827</enrollment>
  <condition>In Vitro Fertilization</condition>
  <arm_group>
    <arm_group_label>TVOR population</arm_group_label>
    <description>The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from all transvaginal oocyte retrieval procedures performed between 1996 and October 2016.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TVOR</intervention_name>
    <description>Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.</description>
    <arm_group_label>TVOR population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All the patients that patients that underwent ultrasound guided transvaginal oocyte&#xD;
        retrieval during the study period were including in the analysis.&#xD;
&#xD;
        No case was excluded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients that underwent ultrasound guided transvaginal oocyte retrieval during the&#xD;
             study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Cirillo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Zannoni, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo E Levi Setti, MD</last_name>
    <role>Study Director</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Bennett SJ, Waterstone JJ, Cheng WC, Parsons J. Complications of transvaginal ultrasound-directed follicle aspiration: a review of 2670 consecutive procedures. J Assist Reprod Genet. 1993 Jan;10(1):72-7. doi: 10.1007/BF01204444.</citation>
    <PMID>8499683</PMID>
  </reference>
  <reference>
    <citation>Ludwig AK, Glawatz M, Griesinger G, Diedrich K, Ludwig M. Perioperative and post-operative complications of transvaginal ultrasound-guided oocyte retrieval: prospective study of &gt;1000 oocyte retrievals. Hum Reprod. 2006 Dec;21(12):3235-40. doi: 10.1093/humrep/del278. Epub 2006 Jul 27.</citation>
    <PMID>16877373</PMID>
  </reference>
  <reference>
    <citation>Bodri D, Guillen JJ, Polo A, Trullenque M, Esteve C, Coll O. Complications related to ovarian stimulation and oocyte retrieval in 4052 oocyte donor cycles. Reprod Biomed Online. 2008 Aug;17(2):237-43. doi: 10.1016/s1472-6483(10)60200-3.</citation>
    <PMID>18681998</PMID>
  </reference>
  <reference>
    <citation>Aragona C, Mohamed MA, Espinola MS, Linari A, Pecorini F, Micara G, Sbracia M. Clinical complications after transvaginal oocyte retrieval in 7,098 IVF cycles. Fertil Steril. 2011 Jan;95(1):293-4. doi: 10.1016/j.fertnstert.2010.07.1054. Epub 2010 Aug 21.</citation>
    <PMID>20727520</PMID>
  </reference>
  <reference>
    <citation>Grynberg M, Berwanger AL, Toledano M, Frydman R, Deffieux X, Fanchin R. Ureteral injury after transvaginal ultrasound-guided oocyte retrieval: a complication of in vitro fertilization-embryo transfer that may lurk undetected in women presenting with severe ovarian hyperstimulation syndrome. Fertil Steril. 2011 Oct;96(4):869-71. doi: 10.1016/j.fertnstert.2011.07.1094. Epub 2011 Aug 11.</citation>
    <PMID>21839435</PMID>
  </reference>
  <reference>
    <citation>Catanzarite T, Bernardi LA, Confino E, Kenton K. Ureteral Trauma During Transvaginal Ultrasound-Guided Oocyte Retrieval: A Case Report. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):e44-5. doi: 10.1097/SPV.0000000000000176.</citation>
    <PMID>25900060</PMID>
  </reference>
  <reference>
    <citation>Kelada E, Ghani R. Bilateral ovarian abscesses following transvaginal oocyte retrieval for IVF: a case report and review of literature. J Assist Reprod Genet. 2007 Apr;24(4):143-5. doi: 10.1007/s10815-006-9090-9. Epub 2007 Feb 16.</citation>
    <PMID>17450435</PMID>
  </reference>
  <reference>
    <citation>Sharpe K, Karovitch AJ, Claman P, Suh KN. Transvaginal oocyte retrieval for in vitro fertilization complicated by ovarian abscess during pregnancy. Fertil Steril. 2006 Jul;86(1):219.e11-3. doi: 10.1016/j.fertnstert.2005.12.045. Epub 2006 May 23.</citation>
    <PMID>16716320</PMID>
  </reference>
  <reference>
    <citation>Bozdag G, Basaran A, Cil B, Esinler I, Yarali H. An oocyte pick-up procedure complicated with pseudoaneurysm of the internal iliac artery. Fertil Steril. 2008 Nov;90(5):2004.e11-3. doi: 10.1016/j.fertnstert.2008.02.010. Epub 2008 Apr 18.</citation>
    <PMID>18423457</PMID>
  </reference>
  <reference>
    <citation>Jayakrishnan K, Raman VK, Vijayalakshmi VK, Baheti S, Nambiar D. Massive hematuria with hemodynamic instability--complication of oocyte retrieval. Fertil Steril. 2011 Jul;96(1):e22-4. doi: 10.1016/j.fertnstert.2011.04.046. Epub 2011 May 19.</citation>
    <PMID>21600575</PMID>
  </reference>
  <reference>
    <citation>Fiori O, Cornet D, Darai E, Antoine JM, Bazot M. Uro-retroperitoneum after ultrasound-guided transvaginal follicle puncture in an oocyte donor: a case report. Hum Reprod. 2006 Nov;21(11):2969-71. doi: 10.1093/humrep/del252. Epub 2006 Aug 29.</citation>
    <PMID>16940321</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oocyte retrieval</keyword>
  <keyword>surgical complications</keyword>
  <!-- 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/NCT03282279
org study id: 17/17
nct id: NCT03282279
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators retrospectively analysed the complication rate of ultrasound guided
      transvaginal oocyte retrieval (TVOR) from all the procedures performed between 1996 and
      October 2016 in a tertiary level university based fertility clinic.
Ultrasound guided transvaginal oocyte retrieval (TVOR) is nowadays gold standard techniques
      to collect oocyte after ovulation induction in Assisted Reproductive techniques (ART). It is
      a very safe technique with infectious complications of any kind occurring in just 1% (Bennett
      et al.) of all procedures, vaginal bleeding in 0 to 1.3% of the procedures (Ludwig et al.,
      Bodri et al., Aragona et al.) and vascular, gastrointestinal and genitourinary (Grynberg et
      al. and Catanzarite and al.), injuries being extremely rare (Bennett et al.). Case reports
      account also for rarer complications such as ovarian abscess formation (Kelada & Ghan and
      Sharp et al.) pseudoanerysm formation (Bozdag et al. and Jayakrishnan et al.),
      uroretroperitoneum (Fiori et al.).

      The rational of thestudy is to provide the percentages of complication from TVOR of the
      Fertility Center of Humanitas Research Hospital, also considering the development in time of
      technologies and techniques in Assisted Reproduction. Another rational is inquire whether
      there is any risk factor for such complications in order to try to prevent them in future
      procedures. The investigators performed a retrospective observational study including all the
      transvaginal oocyte retrieval procedures performed between 1996 and October 2016.

      The data have been collected from the Humanitas Fertility Center' Department database
      (ART.it). Because of the retrospective nature of this study, a specific informed consent was
      not necessary.
observational model: Case-Only
time perspective: Retrospective
measure: complications rate
time frame: 20 years
description: number of oocyte retrieval complications reported / number of procedures
measure: hospitalisation rate
time frame: 20 years
description: number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures
arm group label: TVOR population
description: The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from all transvaginal oocyte retrieval procedures performed between 1996 and October 2016.
intervention type: Procedure
intervention name: TVOR
description: Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.
arm group label: TVOR population
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
last name: Federico Cirillo, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
last name: Elena Zannoni, MD
role: Study Chair
affiliation: Humanitas Research Hospital
last name: Paolo E Levi Setti, MD
role: Study Director
affiliation: Humanitas Research Hospital
citation: Bennett SJ, Waterstone JJ, Cheng WC, Parsons J. Complications of transvaginal ultrasound-directed follicle aspiration: a review of 2670 consecutive procedures. J Assist Reprod Genet. 1993 Jan;10(1):72-7. doi: 10.1007/BF01204444.
PMID: 8499683
citation: Ludwig AK, Glawatz M, Griesinger G, Diedrich K, Ludwig M. Perioperative and post-operative complications of transvaginal ultrasound-guided oocyte retrieval: prospective study of >1000 oocyte retrievals. Hum Reprod. 2006 Dec;21(12):3235-40. doi: 10.1093/humrep/del278. Epub 2006 Jul 27.
PMID: 16877373
citation: Bodri D, Guillen JJ, Polo A, Trullenque M, Esteve C, Coll O. Complications related to ovarian stimulation and oocyte retrieval in 4052 oocyte donor cycles. Reprod Biomed Online. 2008 Aug;17(2):237-43. doi: 10.1016/s1472-6483(10)60200-3.
PMID: 18681998
citation: Aragona C, Mohamed MA, Espinola MS, Linari A, Pecorini F, Micara G, Sbracia M. Clinical complications after transvaginal oocyte retrieval in 7,098 IVF cycles. Fertil Steril. 2011 Jan;95(1):293-4. doi: 10.1016/j.fertnstert.2010.07.1054. Epub 2010 Aug 21.
PMID: 20727520
citation: Grynberg M, Berwanger AL, Toledano M, Frydman R, Deffieux X, Fanchin R. Ureteral injury after transvaginal ultrasound-guided oocyte retrieval: a complication of in vitro fertilization-embryo transfer that may lurk undetected in women presenting with severe ovarian hyperstimulation syndrome. Fertil Steril. 2011 Oct;96(4):869-71. doi: 10.1016/j.fertnstert.2011.07.1094. Epub 2011 Aug 11.
PMID: 21839435
citation: Catanzarite T, Bernardi LA, Confino E, Kenton K. Ureteral Trauma During Transvaginal Ultrasound-Guided Oocyte Retrieval: A Case Report. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):e44-5. doi: 10.1097/SPV.0000000000000176.
PMID: 25900060
citation: Kelada E, Ghani R. Bilateral ovarian abscesses following transvaginal oocyte retrieval for IVF: a case report and review of literature. J Assist Reprod Genet. 2007 Apr;24(4):143-5. doi: 10.1007/s10815-006-9090-9. Epub 2007 Feb 16.
PMID: 17450435
citation: Sharpe K, Karovitch AJ, Claman P, Suh KN. Transvaginal oocyte retrieval for in vitro fertilization complicated by ovarian abscess during pregnancy. Fertil Steril. 2006 Jul;86(1):219.e11-3. doi: 10.1016/j.fertnstert.2005.12.045. Epub 2006 May 23.
PMID: 16716320
citation: Bozdag G, Basaran A, Cil B, Esinler I, Yarali H. An oocyte pick-up procedure complicated with pseudoaneurysm of the internal iliac artery. Fertil Steril. 2008 Nov;90(5):2004.e11-3. doi: 10.1016/j.fertnstert.2008.02.010. Epub 2008 Apr 18.
PMID: 18423457
citation: Jayakrishnan K, Raman VK, Vijayalakshmi VK, Baheti S, Nambiar D. Massive hematuria with hemodynamic instability--complication of oocyte retrieval. Fertil Steril. 2011 Jul;96(1):e22-4. doi: 10.1016/j.fertnstert.2011.04.046. Epub 2011 May 19.
PMID: 21600575
citation: Fiori O, Cornet D, Darai E, Antoine JM, Bazot M. Uro-retroperitoneum after ultrasound-guided transvaginal follicle puncture in an oocyte donor: a case report. Hum Reprod. 2006 Nov;21(11):2969-71. doi: 10.1093/humrep/del252. Epub 2006 Aug 29.
PMID: 16940321
responsible party type: Sponsor