Feasibility study for novel Hormone Monitoring
Research type
Research Study
Full title
Feasibility study of real-time single point hormone monitoring solution using interstitial fluid compared to venous blood
IRAS ID
361062
Contact name
Ula Rustamova
Contact email
Sponsor organisation
Level Zero Health
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Level Zero Health (LZH) is developing a new way to monitor women’s hormonal health.[AP2.1] This is important because hormones levels, such as estradiol and progesterone[AP3.1] (sex hormones for ovarian function and menstrual cycle), can vary more than tenfold within a menstrual cycle. Falling hormone levels during menopause increases the risk of bone density loss, heart disease, and memory problems. In fertility care, hormone monitoring is vital and frequent with blood tests required every 1-3 days. Invasive blood tests [AP4.1]are the current gold standard testing method, only providing single-point snapshots and requiring in-clinic visits with trained staff, a [AP5.1]time consuming and costly process. The NHS itself acknowledges the limitation of one-off blood draws for hormone measurements. This highlights the need for an innovative hormone measurement solution to benefit patients, service providers and the NHS.
LZH is developing a new way to measure hormone levels with clinical accuracy, without the need for in-clinic visits, laboratories, and processing delays. This novel technology [AP6.1]uses interstitial fluid (ISF), a clear liquid in abundance between cells, with similar properties to blood. In this work, a feasibility study, we will extract ISF directly under the skin of the arm of participants. We are looking for participants between 18 and 40 years old with a regular natural menstrual cycle. They will come into the clinic for one session, where the ISF will be extracted using our microsystem[AP7.1]. The hormone levels will be measured by our bespoke measurement system, a lateral flow assay, and the clinical gold standard, mass spectroscopy. A blood sample will also be collected for comparison and analysed using mass spectroscopy. This work will enable us to understand if ISF has comparable hormone levels to blood, and if we can accurately capture this with our measurement method compared to the clinical gold standard.
REC name
East of England - Essex Research Ethics Committee
REC reference
26/EE/0057
Date of REC Opinion
18 Mar 2026
REC opinion
Further Information Favourable Opinion