Oocyte RetrievalPhase 4NCT05631925
Comparison of Two Different Anesthesia Methods in IVF Procedure
A Phase 4 study testing propofol bolus and propofol infusion in people with Oocyte Retrieval, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Retrieval
- What is being tested?
- propofol bolus and propofol infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2022to 17 Aug 2022
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years
- ASA I-II
- Patients who underwent oocyte retrieval for IVF treatment
Who cannot join
- The patient does not want to participate
- ASA > II patients
- Patients under 18 years of age
- Patients who are allergic to the drugs used
- Patients with mental illness
- Patients with alcohol or substance addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization
In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.
Read the detailed description
130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.
- Conditions
- Oocyte Retrieval
- Being tested
- propofol bolus, propofol infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol bolusDrug
Propofol will be added in bolus doses of 0.5mg/kg.
propofol infusionDrug
Propofol will be administered as 10mg/kg/hour infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group bolus | Active comparator | Propofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient. Receives: Drug: propofol bolus |
| Group infusion | Active comparator | Propofol will be administered as 10mg/kg/hour infusion. The infusion dose will be adjusted so that the Bispectral index (BIS) is in the range of 40-60. Receives: Drug: propofol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol
The total amount of Propofol (mg) administered during the procedure
Measured: up to 1 hour
Secondary outcomes (4)
Observer's assessment of sedation scale (OSS)
Time to reach 5 on the observer's assessment of sedation scale of the patients
Measured: up to 1 hour
(Post Anesthetic Discharge Scoring System) PADSS
Time of patients to reach PADSS ≥ 9 (Min:0 and Max: 10) PADSS ≥ 9 is suitable for discharge of the patient
Measured: up to 6 hour
(Satisfaction of patients) STF 1
Patient satisfaction (The scale is in the range of 1-4. 1: the best)
Measured: up to 6 hour
(Satisfaction of gynecologist) STF 2
Satisfaction of the doctor performing the procedure(The scale is in the range of 1-4. 1: the best)
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start27 May 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oocyte RetrievalStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Bilgen, Acibadem University
- Investigators
- Sevgi Bilgen, Study chair, Acibadem University, Acibadem Kozyatagi Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631925
- Sponsor's protocol ID
- SBilgen
- Status last verified
- Dec 2022
- First submitted
- 2 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilgen S, Erdogan D, Okten SB. Infusion of propofol with bispectral index monitoring does not reduce the amount of propofol used during transvaginal oocyte retrieval procedure. Sci Rep. 2023 Dec 6;13(1):21561. doi: 10.1038/s41598-023-48611-6.
PubMed 38057377
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT05631925
- Acronym / sponsor ID
- SBilgen
- Conditions
- Oocyte Retrieval
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 30 Nov 2022 (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.
In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.
Detailed description
130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group bolus | Active comparator | Drug: propofol bolusPropofol will be administered in bolus doses of 0.5mg/kg. Doses will be determined according to the clinical condition of the patient. |
| Group infusion | Active comparator | Drug: propofol infusionPropofol will be administered as 10mg/kg/hour infusion. The infusion dose will be adjusted so that the Bispectral index (BIS) is in the range of 40-60. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- ASA I-II
- Patients who underwent oocyte retrieval for IVF treatment
Key exclusion criteria (6 listed)
- The patient does not want to participate
- ASA > II patients
- Patients under 18 years of age
- Patients who are allergic to the drugs used
- Patients with mental illness
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 |
|---|---|---|
| propofol bolusPropofol will be added in bolus doses of 0.5mg/kg. | Drug | Group bolus |
| propofol infusionPropofol will be administered as 10mg/kg/hour infusion. | Drug | Group infusion |
Primary outcome
Propofol
Time frame: up to 1 hour
The total amount of Propofol (mg) administered during the procedure
4 secondary outcomes
Observer's assessment of sedation scale (OSS)
Time frame: up to 1 hour
(Post Anesthetic Discharge Scoring System) PADSS
Time frame: up to 6 hour
(Satisfaction of patients) STF 1
Time frame: up to 6 hour
(Satisfaction of gynecologist) STF 2
Time frame: up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 38057377Bilgen S, Erdogan D, Okten SB. Infusion of propofol with bispectral index monitoring does not reduce the amount of propofol used during transvaginal oocyte retrieval procedure. Sci Rep. 2023 Dec 6;13(1):21561. doi: 10.1038/s41598-023-48611-6.
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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.
Sevgi Bilgen study chair
Acibadem University, Acibadem Kozyatagi Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol bolus and propofol infusion in people with Oocyte Retrieval, run by Acibadem University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Dec 2022. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631925, which also lists 1 linked publication.
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 7 Dec 2022.