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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05895227
Other study ID # 16/23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 21, 2022

Study information

Verified date May 2023
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13193
Est. completion date December 21, 2022
Est. primary completion date December 21, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Oocyte retrieval


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Outcome

Type Measure Description Time frame Safety issue
Primary Hemoperitoneum after oocyte transvaginal retrieval number of patients with onset of hemoperitoneum Oocyte retrievals in the period January 2017- December 2022
Secondary Operator of the procedure assessment of operator experience 6 years
Secondary Hemoglobin level before and after procedure evaluation of hemoglobin level before and the day after procedure 6 years
Secondary Time of symptoms onset evaluation of first symptoms onset 6 years
Secondary Loss of blood during procedure average blood loss 6 years
Secondary Incidence compared to past case history comparison with previous statistic 6 years
Secondary Need for hospitalization patients requiring hospitalisation 6 years
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