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In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study

In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000036516
Enrollment
35
Registered
2024-01-16
Start date
2024-01-18
Completion date
2024-01-19
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Single blood sample (20mL) 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 p

Single blood sample (20mL) 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 An additional measurement technique will be used in our study. This element will involve further testing of our progesterone samples using a non-immunoassay method. This will allow us to compare progesterone samples with different measurement techniques and observe any differences. This second part of our study will not require any further blood taking or intervention on the part of participants. Additionally consent has already been gained earlier in the study. Ethics approval has already been update and granted for this aspect of our study. When the changes were implemented: After recruitment was completed

Sponsors

Wollongong Hospital Anaesthetics Department
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

premenopausal women

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026