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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
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
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
[email protected]
Contact person for public queries
Name 131079 0
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
[email protected]
Contact person for scientific queries
Name 131080 0
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
[email protected]

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.