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CompletedNCT03134651Updated May 1, 2017

Preoperative Anxiety at Oocyte Retrieval

An interventional study of Monitoring brain function and propofol in Infertility, Female, Anesthesia Awareness and Anxiety State, sponsored by Trakya University. Completed. Open to female participants aged 25 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-01.

Sponsored by Trakya University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jul 2014, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
25 Years to 43 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Female
  • Anesthesia Awareness
  • Anxiety State

Keywords

  • Anxiety
  • Oocyte retrieval
  • Monitoring of brain function
03

In context

Infertility, Female

553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.

This study's enrollment of 131 is above the median of 100 across 377 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

Trakya University is the lead sponsor of 154 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
131 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceMonitoring brain function
  • Also known as: propofol %1

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What researchers measure

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

    Time frame: Preoperative, intraoperative and postoperative first minute

Secondary outcomes

  1. pregnancy rate

    pregnancy rate

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03134651
Lead sponsor
Trakya University
Responsible party
Sevtap Hekimoglu Sahin (Clinical Professor, Trakya University) — Principal investigator
First posted
May 1, 2017
Start date
Jul 24, 2014
Primary completion
Jul 24, 2016
Completion
Sep 24, 2016
Last update
May 1, 2017

Study contacts

Sevtap Hekimoglu Sahin, Professor
study chair · Trakya University Medical Faculty

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Propofol

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