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

March 19, 2019 updated by: Istituto Clinico Humanitas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications rate
Time Frame: 20 years
number of oocyte retrieval complications reported / number of procedures
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospitalisation rate
Time Frame: 20 years
number of oocyte retrieval complications reported that required a admission to the hospital/ number of procedures
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Federico Cirillo, MD, Humanitas Research Hospital
  • Study Chair: Elena Zannoni, MD, Humanitas Research Hospital
  • Study Director: Paolo E Levi Setti, MD, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 1996

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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