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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134651
Other study ID # TUTF-GOKAEK 2014/115
Secondary ID
Status Completed
Phase N/A
First received March 30, 2017
Last updated April 25, 2017
Start date July 24, 2014
Est. completion date September 24, 2016

Study information

Verified date April 2017
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date September 24, 2016
Est. primary completion date July 24, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 43 Years
Eligibility 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 Design


Intervention

Device:
Monitoring brain function

Drug:
propofol


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Preoperative, intraoperative and postoperative first minute
Secondary pregnancy rate pregnancy rate 10 days
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