Study Stopped
Primary investigator transferred in another hospital; ongoing pandemic;
Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval
1 other identifier
observational
80
1 country
1
Brief Summary
The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedStudy Start
First participant enrolled
January 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedSeptember 22, 2020
September 1, 2020
1.9 years
November 5, 2017
September 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
propofol consumption
difference \>30% in propofol consumption
from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary Outcomes (21)
number of oocytes retrieved
up to 3 weeks after starting ovarian stimulation treatment
percentage of mature oocytes
up to 3 weeks after starting ovarian stimulation treatment
fertilization rate
up to 3 weeks after starting ovarian stimulation treatment
embryo quality
up to 4 weeks after starting ovarian stimulation treatment
positive pregnancy test
up to 3 weeks after transvaginal oocyte retrieval
- +16 more secondary outcomes
Study Arms (2)
DEX
Sedation with dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure.
MZM
Sedation with remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min and midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure.
Interventions
Eligibility Criteria
eligible females scheduled for oocyte retrieval
You may not qualify if:
- patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class \>2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attikon Hospitallead
Study Sites (1)
Attikon University Hospital
Athens, Attica, 12462, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology
Study Record Dates
First Submitted
November 5, 2017
First Posted
December 5, 2017
Study Start
January 5, 2018
Primary Completion
November 20, 2019
Study Completion
November 20, 2019
Last Updated
September 22, 2020
Record last verified: 2020-09