Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup

Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup - a Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: IVF
• Intervention / Treatment: Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1130
    • Recruiting
    • Wunschbaby Institut Feichtinger
    • Contact: Michael Feichtinger, MD, PhD; Phone Number: +4318777775; Email: office@wunschbaby.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Patients receive gynaecologist guided individualised propofol sedation	Drug: Propofol; Gynecologist guided individualised propofol only sedation
Active Comparator: Anaesthetic guided anaesthesia; Patients receive anaesthetist guided full anaesthesia	Drug: Propofol; Gynecologist guided individualised propofol only sedation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
Fertilised oocytes	Number of fertilised oocytes	1st of May 2022- 1st of March 2023
Cryopreserved blastocysts	Number of cryopreserved blastocysts	1st of May 2022- 1st of March 2023
Pregnancy rate	Pregnancy rate	1st of May 2022- 1st of March 2023

Collaborators and Investigators

• Sponsor: Wunschbaby Institut Feichtinger

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Sedation; Oocyte Retrieval
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 518-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No