NCT05895227

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,193

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

March 14, 2023

Last Update Submit

May 31, 2023

Conditions

ARTInfertility

Outcome Measures

Primary Outcomes (1)

  • Hemoperitoneum after oocyte transvaginal retrieval

    number of patients with onset of hemoperitoneum

    Oocyte retrievals in the period January 2017- December 2022

Secondary Outcomes (6)

  • Operator of the procedure

    6 years

  • Hemoglobin level before and after procedure

    6 years

  • Time of symptoms onset

    6 years

  • Loss of blood during procedure

    6 years

  • Incidence compared to past case history

    6 years

  • +1 more secondary outcomes

Interventions

Oocyte retrievalPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Paolo Emanuele Levi Setti, M.D.

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

June 8, 2023

Study Start

January 1, 2017

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

June 8, 2023

Record last verified: 2023-05