NCT03134651

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

March 30, 2017

Last Update Submit

April 25, 2017

Conditions

Infertility, FemaleAnesthesia AwarenessAnxiety State

Keywords

AnxietyOocyte retrievalMonitoring of brain function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pregnancy rate

    10 days

Study Arms (2)

Monitoring brain function-low-anxiety

ACTIVE COMPARATOR

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 functionDrug: propofol

monitoring brain function-high-anxiety

ACTIVE COMPARATOR

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 functionDrug: propofol

Interventions

Monitoring brain functionDEVICE
Monitoring brain function-low-anxietymonitoring brain function-high-anxiety
propofolDRUG
Also known as: propofol %1
Monitoring brain function-low-anxietymonitoring brain function-high-anxiety

Eligibility Criteria

Age25 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • oocyte retrieval under sedation
  • and 43 years of age
  • American Society of Anesthesiologists physical status I-II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, FemaleIntraoperative AwarenessAnxiety Disorders

Interventions

Propofol

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityIntraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sevtap Hekimoglu Sahin, Professor

    Trakya University Medical Faculty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

May 1, 2017

Study Start

July 24, 2014

Primary Completion

July 24, 2016

Study Completion

September 24, 2016

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share