Preoperative Anxiety at Oocyte Retrieval

NCT ID: NCT03134651

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-24

Study Completion Date

2016-09-24

Brief Summary

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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

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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

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Infertility, Female Anesthesia Awareness Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Monitoring brain function

Intervention Type DEVICE

propofol

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Monitoring brain function

Intervention Type DEVICE

propofol

Intervention Type DRUG

Interventions

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Monitoring brain function

Intervention Type DEVICE

propofol

Intervention Type DRUG

Other Intervention Names

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propofol %1

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Sevtap Hekimoglu Sahin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevtap Hekimoglu Sahin, Professor

Role: STUDY_CHAIR

Trakya University Medical Faculty

Other Identifiers

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TUTF-GOKAEK 2014/115

Identifier Type: -

Identifier Source: org_study_id

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