- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134651
Preoperative Anxiety at Oocyte Retrieval
April 25, 2017 updated by: Sevtap Hekimoglu Sahin, Trakya University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
131
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 43 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- oocyte retrieval under sedation
- 25 and 43 years of age
- American Society of Anesthesiologists physical status I-II
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Monitoring brain function-low-anxiety
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.
|
Other Names:
|
Active Comparator: monitoring brain function-high-anxiety
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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Preoperative, intraoperative and postoperative first minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy rate
Time Frame: 10 days
|
pregnancy rate
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sevtap Hekimoglu Sahin, Professor, Trakya University Medical Faculty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2014
Primary Completion (Actual)
July 24, 2016
Study Completion (Actual)
September 24, 2016
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
May 1, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUTF-GOKAEK 2014/115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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