IVFNCT05741814
Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup
A study testing Propofol in people with IVF, run by Wunschbaby Institut Feichtinger at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 5 May 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing first oocyte pickup Understands german language to fill out questionnaire
Who cannot join
- BMI >30 BMI <17 Heavy endometriosis Patients undergoing a consecutive IVF attempt
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Wunschbaby Institut Feichtinger
Vienna, 1130
Michael Feichtinger, MD, PhD, +4318777775, office@wunschbaby.at
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Gynecologist guided individualised propofol only sedation
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Patients receive gynaecologist guided individualised propofol sedation Receives: Drug: Propofol |
| Anaesthetic guided anaesthesia | Active comparator | Patients receive anaesthetist guided full anaesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction measured by the ZUF-8 questionnaire (Questionnaire to evaluate patient satisfaction)
Measured: May 2022-March 2023
Secondary outcomes (5)
Retrieved oocytes
Number of retrieved oocytes
Measured: 1st of May 2022- 1st of March 2023
Mature oocytes
Number of mature oocytes
Measured: 1st of May 2022-1st of March 2023
Fertilised oocytes
Number of fertilised oocytes
Measured: 1st of May 2022- 1st of March 2023
Cryopreserved blastocysts
Number of cryopreserved blastocysts
Measured: 1st of May 2022- 1st of March 2023
Pregnancy rate
Pregnancy rate
Measured: 1st of May 2022- 1st of March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start5 May 2022
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wunschbaby Institut Feichtinger
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Feichtinger, Wunschbaby Institut Feichtinger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741814
- Sponsor's protocol ID
- 518-2022
- Status last verified
- May 2024
- First submitted
- 7 Nov 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup - a Prospective Study
- ClinicalTrials.gov ID
- NCT05741814
- Acronym / sponsor ID
- 518-2022
- Conditions
- IVF
- Keywords
- Oocyte Retrieval, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wunschbaby Institut FeichtingerUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPatients receive gynaecologist guided individualised propofol sedation |
| Anaesthetic guided anaesthesia | Active comparator | Drug: PropofolPatients receive anaesthetist guided full anaesthesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient undergoing first oocyte pickup Understands german language to fill out questionnaire
Key exclusion criteria (1 listed)
- BMI >30 BMI <17 Heavy endometriosis Patients undergoing a consecutive IVF attempt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolGynecologist guided individualised propofol only sedation | Drug | Anaesthetic guided anaesthesia, Propofol |
Primary outcome
Patient satisfaction
Time frame: May 2022-March 2023
Patient satisfaction measured by the ZUF-8 questionnaire (Questionnaire to evaluate patient satisfaction)
5 secondary outcomes
Retrieved oocytes
Time frame: 1st of May 2022- 1st of March 2023
Mature oocytes
Time frame: 1st of May 2022-1st of March 2023
Fertilised oocytes
Time frame: 1st of May 2022- 1st of March 2023
Cryopreserved blastocysts
Time frame: 1st of May 2022- 1st of March 2023
Pregnancy rate
Time frame: 1st of May 2022- 1st of March 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with IVF, run by Wunschbaby Institut Feichtinger at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: May 2022-March 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.