Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup

Sponsor

Wunschbaby Institut Feichtinger (Other)

Overall Status

Recruiting

CT.gov ID

NCT05741814

Collaborator

(none)

100

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IVF	Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient satisfaction [May 2022-March 2023]
Patient satisfaction measured by the ZUF-8 questionnaire (Questionnaire to evaluate patient satisfaction)

Secondary Outcome Measures

Retrieved oocytes [1st of May 2022- 1st of March 2023]
Number of retrieved oocytes
Mature oocytes [1st of May 2022-1st of March 2023]
Number of mature oocytes
Fertilised oocytes [1st of May 2022- 1st of March 2023]
Number of fertilised oocytes
Cryopreserved blastocysts [1st of May 2022- 1st of March 2023]
Number of cryopreserved blastocysts
Pregnancy rate [1st of May 2022- 1st of March 2023]
Pregnancy rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wunschbaby Institut Feichtinger	Vienna		Austria	1130

Sponsors and Collaborators

Wunschbaby Institut Feichtinger

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Feichtinger, Principal Investigator, Wunschbaby Institut Feichtinger

ClinicalTrials.gov Identifier:

NCT05741814

Other Study ID Numbers:

518-2022

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Feichtinger, Principal Investigator, Wunschbaby Institut Feichtinger

Oocyte Retrieval

Sedation

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Feb 23, 2023