Hemorrhagic Complications of Transvaginal Oocyte's Retrie... | NCT05895227

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

NCT05895227

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Jun 8, 2023Actual

Enrollment

13,193Actual

Phase

Not provided

Conditions

ART
Infertility

Interventions

Oocyte retrieval

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 21, 2022Actual

Completion Date

Dec 21, 2022Actual

First Submitted Date

Mar 14, 2023

First Submission Date that Met QC Criteria

May 31, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2023

Last Update Posted Date

Jun 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13,193Actual

Name	Type	Description	Arm Group Labels	Other Names
Oocyte retrieval	Procedure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Operator of the procedure	assessment of operator experience	6 years
Hemoglobin level before and after procedure	evaluation of hemoglobin level before and the day after procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paolo Emanuele Levi Setti, M.D.	Istituto Clinico Humanitas	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054315	Oocyte Retrieval

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D020858	Tissue and Organ Harvesting

Browse Leaves

Not provided

Browse Branches

Not provided