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Trial registered on ANZCTR
Registration number
ACTRN12624000036516
Ethics application status
Approved
Date submitted
7/12/2023
Date registered
16/01/2024
Date last updated
16/01/2024
Date data sharing statement initially provided
16/01/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study
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Scientific title
In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study
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Secondary ID [1]
311115
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pregnancy
332301
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contraceptive effectviness
332302
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Condition category
Condition code
Anaesthesiology
329013
329013
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0
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Anaesthetics
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Reproductive Health and Childbirth
329014
329014
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0
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Contraception
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Single blood sample (~10mL) collected using routine blood collection techniques from premenopausal women. Then testing if sugammadex interacts with a progesterone assay at various sugammadex concentrations.
Serum samples will be centrifuged and spiked with various sugammadex concentrations. Serum sample divided into 7 volumes and spiked with: 10, 40 , 80, 160, 480, 600, 1200, 4800 microM sugammadex concentrations
The assay being utilised is Elecsys Progesterone III
The only involvement by participiants is the provision of blood
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Intervention code [1]
327582
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Not applicable
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Comparator / control treatment
one control will contain only serum
The second control with contain serum + saline (to replicate the added volume containing sugammadex in the other samples)
neither controls will contain sugammadex
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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progesterone concentration
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Assessment method [1]
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serum progesterone assay
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Timepoint [1]
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single timepoint, immediately after mixing blood sample with sugammadex
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
premenopausal women
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Male participants
- Females <18 years old or >50 years old
- Post-menopausal women
- Incomplete/missing key details in questionnaire form
- On hormonal contraception
- Women who may be pregnant
- Women with bilateral ovariectomy
- Sample A & B progesterone levels below level of assay
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/01/2024
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Actual
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Date of last participant enrolment
Anticipated
31/01/2024
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Actual
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Date of last data collection
Anticipated
31/01/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
25933
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
41767
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2500 - Wollongong
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Funding & Sponsors
Funding source category [1]
315373
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Hospital
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Name [1]
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Wollongong Hospital Anaesthetics Department
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Address [1]
315373
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Loftus St, Wollongong NSW 2500
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Country [1]
315373
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Australia
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Primary sponsor type
Hospital
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Name
Wollongong Hospital Anaesthetics Department
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Address
Loftus St, Wollongong NSW 2500
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
317434
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Country [1]
317434
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
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Ethics committee address [1]
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Northfields Ave, Wollongong NSW 2522
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/05/2023
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Approval date [1]
314290
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01/09/2023
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Ethics approval number [1]
314290
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Summary
Brief summary
This research project is looking at whether sugammadex interacts with progesterone assay testing, and therefore affects the reliability of progesterone concentration measurements. An interaction at 104micromol/L is reported by the manufacturer of Sugammadex. This research project will look at the accuracy of progesterone assay testing in the presence of various sugammadex concentrations.. This study is important to assess the reliability of data that utilising progesterone assay testing when using sugammadex.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Tamblyn Devoy
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Address
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Wollongong Hospital, Loftus St, Wollongong NSW 2500
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Country
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Australia
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Phone
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+61 400038321
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Tamblyn Devoy
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Address
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Wollongong Hospital, Loftus St, Wollongong NSW 2500
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Country
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Australia
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Phone
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+61 400038321
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tamblyn Devoy
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Address
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Wollongong Hospital, Loftus St, Wollongong NSW 2500
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Country
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Australia
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Phone
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+61 400038321
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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