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

NCT ID: NCT03282279

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23827 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-06-23
• Study Completion Date: 2017-09-30

Brief 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.

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.

Conditions

In Vitro Fertilization

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

TVOR

Intervention Type: PROCEDURE

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

Interventions

TVOR

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federico Cirillo, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Elena Zannoni, MD

Role: STUDY_CHAIR

Humanitas Research Hospital IRCCS, Rozzano-Milan

Paolo E Levi Setti, MD

Role: STUDY_DIRECTOR

Humanitas Research Hospital IRCCS, Rozzano-Milan

References

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.

Reference Type: BACKGROUND

PMID: 8499683 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16877373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18681998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20727520 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21839435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25900060 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17450435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16716320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18423457 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21600575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16940321 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29871795 (View on PubMed)

Other Identifiers

17/17

Identifier Type: -

Identifier Source: org_study_id