Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.

May 31, 2023 updated by: Istituto Clinico Humanitas
The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main aim is to update our knowledge on oocyte retrieval complication, focusing specifically on hemorrhagic / hemoperitoneum rate.

All retrievals will be retrieved in IVF/ICSI cycles and Fertility Preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.

Data collection goes from January 2017 to December 2022.

Study Type

Observational

Enrollment (Actual)

13193

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients that underwent oocyte retrieval procedure at Humanitas Fertility Center during the period January 2017 - December 2022, in IVF/ICSI cycles and fertility preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.

Description

Inclusion Criteria:

  • patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation

Exclusion Criteria:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoperitoneum after oocyte transvaginal retrieval
Time Frame: Oocyte retrievals in the period January 2017- December 2022
number of patients with onset of hemoperitoneum
Oocyte retrievals in the period January 2017- December 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator of the procedure
Time Frame: 6 years
assessment of operator experience
6 years
Hemoglobin level before and after procedure
Time Frame: 6 years
evaluation of hemoglobin level before and the day after procedure
6 years
Time of symptoms onset
Time Frame: 6 years
evaluation of first symptoms onset
6 years
Loss of blood during procedure
Time Frame: 6 years
average blood loss
6 years
Incidence compared to past case history
Time Frame: 6 years
comparison with previous statistic
6 years
Need for hospitalization
Time Frame: 6 years
patients requiring hospitalisation
6 years

Collaborators and Investigators

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

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Paolo Emanuele Levi Setti, M.D., Istituto Clinico Humanitas

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)

January 1, 2017

Primary Completion (Actual)

December 21, 2022

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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