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

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Completed
CT.gov ID
NCT03282279
Collaborator
(none)
23,827
255.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TVOR

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 Design

Study Type:
Observational
Actual Enrollment :
23827 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).
Actual Study Start Date :
Jun 23, 1996
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Sep 30, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. complications rate [20 years]

    number of oocyte retrieval complications reported / number of procedures

Secondary Outcome Measures

  1. hospitalisation rate [20 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 46 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients that underwent ultrasound guided transvaginal oocyte retrieval during the study period
Exclusion Criteria:
  • none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT03282279
Other Study ID Numbers:
  • 17/17
First Posted:
Sep 13, 2017
Last Update Posted:
Mar 21, 2019
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Clinico Humanitas

Study Results

No Results Posted as of Mar 21, 2019