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Preoperative Anxiety at Oocyte Retrieval

Primary Purpose

Infertility, Female, Anesthesia Awareness, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monitoring brain function
propofol
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Anxiety, Oocyte retrieval, Monitoring of brain function

Eligibility Criteria

25 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Monitoring brain function-low-anxiety

    monitoring brain function-high-anxiety

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    pregnancy rate
    pregnancy rate

    Full Information

    First Posted
    March 30, 2017
    Last Updated
    April 25, 2017
    Sponsor
    Trakya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03134651
    Brief Title
    Preoperative Anxiety at Oocyte Retrieval
    Official Title
    The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 24, 2014 (Actual)
    Primary Completion Date
    July 24, 2016 (Actual)
    Study Completion Date
    September 24, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Trakya University

    4. Oversight

    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

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female, Anesthesia Awareness, Anxiety State
    Keywords
    Anxiety, Oocyte retrieval, Monitoring of brain function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    131 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Monitoring brain function-low-anxiety
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    monitoring brain function-high-anxiety
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Monitoring brain function
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Other Intervention Name(s)
    propofol %1
    Primary Outcome Measure Information:
    Title
    Changes in perioperative Monitoring brain function were measured
    Description
    Monitoring brain function was assessed Change from baseline at preoperatively, intraoperative 5th and 15th minutes and after anesthesia
    Time Frame
    Preoperative, intraoperative and postoperative first minute
    Secondary Outcome Measure Information:
    Title
    pregnancy rate
    Description
    pregnancy rate
    Time Frame
    10 days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    infertile women
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sevtap Hekimoglu Sahin, Professor
    Organizational Affiliation
    Trakya University Medical Faculty
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Preoperative Anxiety at Oocyte Retrieval

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