Trial Review

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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
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
Secondary ID [1] 311115 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 332301 0
contraceptive effectviness 332302 0
Condition category
Condition code
Anaesthesiology 329013 329013 0 0
Anaesthetics
Reproductive Health and Childbirth 329014 329014 0 0
Contraception

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 327582 0
Not applicable
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
Control group
Dose comparison

Outcomes
Primary outcome [1] 336806 0
progesterone concentration
Timepoint [1] 336806 0
single timepoint, immediately after mixing blood sample with sugammadex
Secondary outcome [1] 429721 0
Nil
Timepoint [1] 429721 0
Nil

Eligibility
Key inclusion criteria
premenopausal women
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/01/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25933 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 41767 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 315373 0
Hospital
Name [1] 315373 0
Wollongong Hospital Anaesthetics Department
Country [1] 315373 0
Australia
Primary sponsor type
Hospital
Name
Wollongong Hospital Anaesthetics Department
Address
Loftus St, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 317434 0
None
Name [1] 317434 0
Address [1] 317434 0
Country [1] 317434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314290 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 314290 0
Northfields Ave, Wollongong NSW 2522
Ethics committee country [1] 314290 0
Australia
Date submitted for ethics approval [1] 314290 0
04/05/2023
Approval date [1] 314290 0
01/09/2023
Ethics approval number [1] 314290 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131078 0
Dr Tamblyn Devoy
Address 131078 0
Wollongong Hospital, Loftus St, Wollongong NSW 2500
Country 131078 0
Australia
Phone 131078 0
+61 400038321
Fax 131078 0
Email 131078 0
tamblyn.devoy@health.nsw.gov.au
Contact person for public queries
Name 131079 0
Dr Tamblyn Devoy
Address 131079 0
Wollongong Hospital, Loftus St, Wollongong NSW 2500
Country 131079 0
Australia
Phone 131079 0
+61 400038321
Fax 131079 0
Email 131079 0
tamblyn.devoy@health.nsw.gov.au
Contact person for scientific queries
Name 131080 0
Dr Tamblyn Devoy
Address 131080 0
Wollongong Hospital, Loftus St, Wollongong NSW 2500
Country 131080 0
Australia
Phone 131080 0
+61 400038321
Fax 131080 0
Email 131080 0
tamblyn.devoy@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.