Infertility, FemaleNCT03134651
Preoperative Anxiety at Oocyte Retrieval
A study testing Monitoring brain function and propofol in people with Infertility, Female and Anesthesia Awareness, run by Trakya University.
Trial summary
This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group. Read more about this study
- Who is it for?
- Ages 25 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Anesthesia Awareness, Anxiety State
- What is being tested?
- Monitoring brain function and propofol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2014to 24 Sep 2016
- 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 25 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- oocyte retrieval under sedation
- 25 and 43 years of age
- American Society of Anesthesiologists physical status I-II
Who cannot join
- history of psychiatric illness
- secondary infertility can be surgically corrected
- not able to communicate well in the native language
- those women who necessitated general anesthesia
About this study
Official title: The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success
This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group.
Read the detailed description
Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually accompanied by psychological and behavioral changes and can result in preoperative anxiety. Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on recovery from anesthesia. In addition, the negative effect of anesthetic agents used on fertilization and embryo quality during in vitro fertilization (IVF) has been discussed. However, the impact of any of them on fertilization and embryo quality has not been clearly determined to date. Studies have reported different results regarding the negative effects of anesthetic agents on embryo development and fertilization.
- Conditions
- Infertility, Female, Anesthesia Awareness, Anxiety State
- Being tested
- Monitoring brain function, propofol
- Keywords
- Anxiety, Oocyte retrieval, Monitoring of brain function
- Medical subject headings
- Infertility, Female, Intraoperative Awareness, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring brain functionDevice
propofolDrug
Also called propofol %1
| Study group | Role | What they receive |
|---|---|---|
| Monitoring brain function-low-anxiety | Active comparator | Anxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60. Receives: Device: Monitoring brain function; Drug: propofol |
| monitoring brain function-high-anxiety | Active comparator | Anxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60. Receives: Device: Monitoring brain function; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in perioperative Monitoring brain function were measured
Monitoring brain function was assessed Change from baseline at preoperatively, intraoperative 5th and 15th minutes and after anesthesia
Measured: Preoperative, intraoperative and postoperative first minute
Secondary outcomes (1)
pregnancy rate
pregnancy rate
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start24 Jul 2014
- Primary completion24 Jul 2016
- Study completion24 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Hekimoglu Sahin, Trakya University
- Investigators
- Sevtap Hekimoglu Sahin, Professor, Study chair, Trakya University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134651
- Sponsor's protocol ID
- TUTF-GOKAEK 2014/115
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 1 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success
- ClinicalTrials.gov ID
- NCT03134651
- Acronym / sponsor ID
- TUTF-GOKAEK 2014/115
- Conditions
- Infertility, Female, Anesthesia Awareness, Anxiety State
- Keywords
- Anxiety, Oocyte retrieval, Monitoring of brain function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 24 Jul 2016 (actual)
- Study completion
- 24 Sep 2016 (actual)
- First posted
- 1 May 2017 (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.
This study evaluated the effects of preoperative anxiety and dosage of anesthesia on IVF success. Half of participants according to the recorded Beck's Anxiety Inventory (BAI) score: a low-anxiety group, while the other half high-anxiety group.
Detailed description
Anxiety is common among women hospitalized for oocyte retrieval. Infertility is usually accompanied by psychological and behavioral changes and can result in preoperative anxiety. Sometimes, preoperative anxiety can be serious. Furthermore, in the absence of premedication for oocyte retrieval, severe degrees of anxiety may occur. Anxiety effects the total consumption of analgesic and anesthetic drugs intraoperatively and has a negative impact on recovery from anesthesia. In addition, the negative effect of anesthetic agents used on fertilization and embryo quality during in vitro fertilization (IVF) has been discussed. However, the impact of any of them on fertilization and embryo quality has not been clearly determined to date. Studies have reported different results regarding the negative effects of anesthetic agents on embryo development and fertilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring brain function-low-anxiety | Active comparator | Device: Monitoring brain function, Drug: propofolAnxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60. |
| monitoring brain function-high-anxiety | Active comparator | Device: Monitoring brain function, Drug: propofolAnxiety has determined a cutoff score of 17. Patients were divided into two groups according to the recorded BAI score: a low-anxiety group and a high-anxiety group.The monitoring brain function values were recorded at baseline, 5 minutes, 15 minutes, and after anesthesia. Propofol was performed by ventilation with face mask. Monitoring brain function was keep value between 40 and 60. |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- oocyte retrieval under sedation
- 25 and 43 years of age
- American Society of Anesthesiologists physical status I-II
Key exclusion criteria (4 listed)
- history of psychiatric illness
- secondary infertility can be surgically corrected
- not able to communicate well in the native language
- those women who necessitated general anesthesia
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 |
|---|---|---|
| Monitoring brain function | Device | Monitoring brain function-low-anxiety, monitoring brain function-high-anxiety |
| propofolAlso: propofol %1 | Drug | Monitoring brain function-low-anxiety, monitoring brain function-high-anxiety |
Primary outcome
Changes in perioperative Monitoring brain function were measured
Time frame: Preoperative, intraoperative and postoperative first minute
Monitoring brain function was assessed Change from baseline at preoperatively, intraoperative 5th and 15th minutes and after anesthesia
1 secondary outcome
pregnancy rate
Time frame: 10 days
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 1 May 2017.
- Individual participant dataSharing planned: No
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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.
Sevtap Hekimoglu Sahin, Professor study chair
Trakya University Medical Faculty
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring brain function and propofol in people with Infertility, Female and Anesthesia Awareness, run by Trakya University.
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 4 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Changes in perioperative Monitoring brain function were measured (time frame: Preoperative, intraoperative and postoperative first minute). 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 1 May 2017.