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Preoperative Anxiety at Oocyte Retrieval

Sponsor
Trakya University (Other)
Overall Status
Completed
CT.gov ID
NCT03134651
Collaborator
(none)
131
Enrollment
2
Arms
26.1
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Preoperative Anxiety With Depth of Anesthesia During Oocyte Retrieval on IVF Success
Actual Study Start Date :
Jul 24, 2014
Actual Primary Completion Date :
Jul 24, 2016
Actual Study Completion Date :
Sep 24, 2016

Arms and Interventions

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.

Device: Monitoring brain function

Drug: propofol
Other Names:
  • propofol %1

    		•
    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.

    Device: Monitoring brain function

    Drug: propofol
    Other Names:
  • propofol %1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in perioperative Monitoring brain function were measured [Preoperative, intraoperative and postoperative first minute]

      Monitoring brain function was assessed Change from baseline at preoperatively, intraoperative 5th and 15th minutes and after anesthesia

    Secondary Outcome Measures

    1. pregnancy rate [10 days]

      pregnancy rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 43 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Trakya University

    Investigators

    • Study Chair: Sevtap Hekimoglu Sahin, Professor, Trakya University Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
    ClinicalTrials.gov Identifier:
    NCT03134651
    Other Study ID Numbers:
    • TUTF-GOKAEK 2014/115
    First Posted:
    May 1, 2017
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
    Anxiety
    Oocyte retrieval
    Monitoring of brain function
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Intraoperative Awareness
    Anxiety Disorders
    Propofol

    Study Results

    No Results Posted as of May 1, 2017