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

Completed

• Conditions: In Vitro Fertilization
• Interventions: Procedure: TVOR

• Registration Number: NCT03282279
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 1996-06-23
• Status Verified: 2017-09
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23827

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TVOR population	TVOR	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.

Primary Outcome Measures

Name	Time	Method
complications rate	20 years	number of oocyte retrieval complications reported / number of procedures

Secondary Outcome Measures

Name	Time	Method
hospitalisation rate	20 years	number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures