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

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:
  • 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.
Other Names:
  • propofol %1

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.

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

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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