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

In Vitro Fertilization Clinical Trial

— TVOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282279
• Other study ID #: 17/17
• Status: Completed
• Start date: June 23, 1996
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2017
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23827
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (11)

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. — View 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. — View Citation

Bodri D, Guillén 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. — View 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. — View 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. — View 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. Epub 2006 Aug 29. — View 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. — View 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. — View 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. Epub 2007 Feb 16. — View 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. Epub 2006 Jul 27. — View 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. Epub 2006 May 23. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications rate	number of oocyte retrieval complications reported / number of procedures	20 years
Secondary	hospitalisation rate	number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures	20 years