NCT05741814

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 5, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

November 7, 2022

Last Update Submit

May 11, 2024

Conditions

IVF

Keywords

Oocyte RetrievalSedation

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Patient satisfaction measured by the ZUF-8 questionnaire (Questionnaire to evaluate patient satisfaction)

    May 2022-March 2023

Secondary Outcomes (5)

  • Retrieved oocytes

    1st of May 2022- 1st of March 2023

  • Mature oocytes

    1st of May 2022-1st of March 2023

  • Fertilised oocytes

    1st of May 2022- 1st of March 2023

  • Cryopreserved blastocysts

    1st of May 2022- 1st of March 2023

  • Pregnancy rate

    1st of May 2022- 1st of March 2023

Study Arms (2)

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

PropofolDRUG

Gynecologist guided individualised propofol only sedation

Anaesthetic guided anaesthesiaPropofol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between 18-40 years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wunschbaby Institut Feichtinger

Vienna, 1130, Austria

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2022

First Posted

February 23, 2023

Study Start

May 5, 2022

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

AU(1)