Propofol Sedation vs. Anaesthetist Guided Anaesthesia in... | NCT05741814

Studies
Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup

NCT05741814

Sponsor

Wunschbaby Institut Feichtinger

Status

Unknown status

Last Update Posted

May 14, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Interventions

Propofol

Countries

Austria

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 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2022Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Nov 7, 2022

First Submission Date that Met QC Criteria

Feb 14, 2023

First Posted Date

Feb 23, 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 11, 2024

Last Update Posted Date

May 14, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Feichtinger, Principal Investigator, Wunschbaby Institut FeichtingerPrincipal Investigator

Lead Sponsor

Wunschbaby Institut FeichtingerOTHER

Collaborators

Not provided

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

Patients undergoing their first course of in vitro fertilisation receive either gynaecologist guided propofol only sedation or anaesthetist guided full anaesthesia. Patient satisfaction and clinical outcome will be evaluated afterwards.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol	Active Comparator	Patients receive gynaecologist guided individualised propofol sedation	Drug: Propofol
Anaesthetic guided anaesthesia	Active Comparator	Patients receive anaesthetist guided full anaesthesia	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	Gynecologist guided individualised propofol only sedation	Anaesthetic guided anaesthesia Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction	Patient satisfaction measured by the ZUF-8 questionnaire (Questionnaire to evaluate patient satisfaction)	May 2022-March 2023

Secondary Outcomes

Measure	Description	Time Frame
Retrieved oocytes	Number of retrieved oocytes	1st of May 2022- 1st of March 2023
Mature oocytes	Number of mature oocytes	1st of May 2022-1st of March 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing first oocyte pickup Understands german language to fill out questionnaire

Exclusion Criteria:

BMI >30 BMI <17 Heavy endometriosis Patients undergoing a consecutive IVF attempt

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women between 18-40 years

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wunschbaby Institut Feichtinger	Recruiting	Vienna		1130	Austria

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

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Browse Branches

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