CClinicalTrials.gg
CompletedNCT03282279TVORUpdated Mar 21, 2019

Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).

An observational study in In Vitro Fertilization, sponsored by Istituto Clinico Humanitas. Completed. Open to female participants aged 18 Years to 46 Years. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Istituto Clinico Humanitas · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
23,827
Ages
18 Years to 46 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • In Vitro Fertilization

Keywords

  • oocyte retrieval
  • surgical complications
03

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All the patients that patients that underwent ultrasound guided transvaginal oocyte retrieval during the study period were including in the analysis.

No case was excluded.

Inclusion criteria

  • patients that underwent ultrasound guided transvaginal oocyte retrieval during the study period

Exclusion criteria

Exclusion Criteria:

  • none
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
23,827 participants (actual)
Patient registry
No

Groups and cohorts

  • TVOR population

    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.

    Procedure: TVOR

Interventions

  • ProcedureTVOR

    Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.

05

What researchers measure

Primary outcomes

  1. complications rate

    number of oocyte retrieval complications reported / number of procedures

    Time frame: 20 years

Secondary outcomes

  1. hospitalisation rate

    number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures

    Time frame: 20 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 8499683 ↗
  • 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. PubMed 16877373 ↗
  • 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. PubMed 18681998 ↗
  • 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. PubMed 20727520 ↗
  • 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. PubMed 21839435 ↗
  • 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. PubMed 25900060 ↗
  • 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. PubMed 17450435 ↗
  • 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. PubMed 16716320 ↗
  • 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. PubMed 18423457 ↗
  • 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. PubMed 21600575 ↗
  • 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. PubMed 16940321 ↗
  • Levi-Setti PE, Cirillo F, Scolaro V, Morenghi E, Heilbron F, Girardello D, Zannoni E, Patrizio P. Appraisal of clinical complications after 23,827 oocyte retrievals in a large assisted reproductive technology program. Fertil Steril. 2018 Jun;109(6):1038-1043.e1. doi: 10.1016/j.fertnstert.2018.02.002. Epub 2018 Jun 2. PubMed 29871795 ↗
08

Registry details

Key details

Study ID
NCT03282279
Lead sponsor
Istituto Clinico Humanitas
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Jun 23, 1996
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017
Last update
Mar 21, 2019

Study contacts

Federico Cirillo, MD
principal investigator · Humanitas Research Hospital
Elena Zannoni, MD
study chair · Humanitas Research Hospital
Paolo E Levi Setti, MD
study director · Humanitas Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion