Study to investigate the temperature and dissolved oxygen levels in the uterine cavity of females with normal menstrual cycles
| ISRCTN | ISRCTN16822938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16822938 |
| IRAS number | 316600 |
| Secondary identifying numbers | CPMS 57213 |
- Submission date
- 17/06/2025
- Registration date
- 03/07/2025
- Last edited
- 18/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The study aims to collect data on the temperature and dissolved oxygen levels in women during the different phases of their menstrual cycles. The trial will provide data to support treatments for women's uterine health.
Who can participate?
Women with regular menstrual cycles, between the ages of 18-42 years
What does the study involve?
Participants would be enrolled into one group and will have the uterine monitoring device implanted for 7 days only.
What are the possible benefits and risks of participating?
Possible benefits:
Participants will be helping the development of a new device that will improve the understanding of uterine health. The trial will provide data to support future women’s health treatment and revolutionise uterine health so women can make empowered decisions.
Participants will be compensated for their time, inconvenience, and the procedure carried out. If they attend the screening appointment and are eligible to take part in the study, they will be compensated a total of £700 for their travel expenses, the insertion of the device and the following days up to its removal.
Possible risks:
The common risks of any intrauterine device are as listed.
Insertion of the device can cause injury to the womb; an example would be perforation, which is a hole in the womb ( approx. 2 in every 1000).
Pain/ discomfort (approx. 12 -22 in every 100 ), mild bleeding on insertion/removal (15 in every 100), and infection (approx. 2 in every 1000).
Insertion under ultrasound guidance will allow the gynaecologist to see where he is placing the device and avoid as far as possible any injury to the womb. The pain and discomfort in most cases will be short-lasting, and you will be able to take painkillers prior to the insertion. Rarely, the pain may continue after insertion. In these instances, there is the option for the device to be removed early. There is also the option of having local anaesthetic in the cervix (neck of the womb) during insertion if you wish. The risk of infection is small and would be treatable with antibiotics. Infection could also lead to pelvic inflammatory disease or fertility problems.
Where is the study run from?
Verso Biosense Limited, UK, with multiple participating sites around the UK.
When is the study starting and how long is it expected to run for?
January 2023 to December 2025
Who is funding the study?
Verso Biosense Ltd, UK
Who is the main contact?
Main contact: Chief Investigator- Prof Roy Homburg, royhomburg@gmail.com
Sponsor Contact: Mariea Parvaz, Clinical Trials Manager, m.parvaz@versobiosense.com
Contact information
Public, Scientific
Verso Biosense Limited
115B Innovation Drive
Abingdon
OX14 4RZ
United Kingdom
| Phone | +44 (0)7785465955 |
|---|---|
| m.parvaz@versobiosense.com |
Principal Investigator
University College London Hospitals NHS Foundation Trust
Women’s Health Division, 250 Euston Road
London
NW1 2BU
United Kingdom
| Phone | +44 (0)7484608134 |
|---|---|
| royhomburg@gmail.com |
Study information
| Study design | Multicenter feasibility non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Other |
| Study type | Other, Safety |
| Participant information sheet | See study outputs table |
| Scientific title | Study to investigate and monitor the intra-uterine temperature and intra-uterine dissolved oxygen levels across 7 days in females with normal menstrual cycles. |
| Study acronym | VB002 |
| Study objectives | A comprehensive investigation has been performed into the available data around biophysical sensing in the reproductive tract. It concluded that very little human data exists. There is a limited number of devices designed to monitor the reproductive tract environment, namely dissolved oxygen (DO), temperature, and none monitor the in vivo environment. These parameters are deemed crucial in embryo development, and it is hoped that these data will identify optimal conditions and lead to the development of treatment. Also the available methods are thought to give inaccurate and imprecise measurements. The data made available through this sensing technology in utero may help to provide new insights into how best to optimize the in vitro embryo environment and allow for more precise and personalized fertility treatment, and to increase the chances of IVF success. |
| Ethics approval(s) |
Approved 22/02/2023, West Midlands - Edgbaston Research Ethics Committee (3rd Floor Barlow House, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8155; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0012 |
| Health condition(s) or problem(s) studied | Reproductive health |
| Intervention | All participants would be enrolled into one group and will have the device implanted for 7 days only between days 14-21 of their menstrual cycle. The device will monitor uterine temperature and dissolved oxygen through the study week. Participants will have a follow-up call on days 2, 4 and 6, followed by a removal visit on day 7. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | IRIS system intrauterine monitoring device |
| Primary outcome measure | Intrauterine dissolved oxygen levels and intrauterine temperature measured using data collected from the IRIS device over 7 days in healthy volunteer females with normal menstrual cycles. |
| Secondary outcome measures | 1. Device safety will be assessed using the following variables: 1.1. Number and occurrence of known clinical risks measured using clinical observation and reporting at study completion 1.2. Adverse events measured using participant reports and clinical records at study completion 1.3. Analgesic consumption measured using data collected in a patient diary across seven days post-procedure 2. Device user acceptance will be assessed using the following variables: 2.1. Tolerance of device use measured using a patient diary across seven days post-procedure 2.2. Frequency of study withdrawal and completion measured using participant tracking at study completion 2.3. User experience measured using a patient questionnaire at a 3-day follow-up |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 42 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Women with regular menstrual cycles of approximate even duration e.g between 21-35 days 2. Women who are at least 18 years of age and less than or equal to 42 years of age 3. Clinically suitable for insertion of an intra-uterine device in an outpatient setting 4. No chronic illness e.g. diabetes, autoimmune disorders 5. Patient able to comprehend and sign the Informed Consent prior to enrolment in the study 6. BMI range 20 to 27 7. Able and willing to use barrier contraception (male condoms) or abstain from sexual intercourse during the menstrual cycle of the trial period |
| Key exclusion criteria | 1. Pregnant, breastfeeding or planning a pregnancy during the course of the trial. 2. Pregnancies within the previous 3 months 3. Using hormonal contraception/therapies 4. History of miscarriage 5. Birth abnormalities or complications from previous pregnancies 6. Uterine anatomical abnormalities which, in the opinion of the investigator, may complicate the placement and removal of the device. 7. Concomitant medical treatment for or has any significant disease or disorder which, in the opinion of the investigator, may put the participants at risk. 8. Known allergies to local anaesthetics, silicone and barium sulphate (both are components of the device) 9. Undergoing investigation for abnormal uterine bleeding. 10. Current pelvic inflammatory disease, cervicitis, current genital infection, conditions associated with increased susceptibility to infections, cervical dysplasia, uterine or cervical malignancy. 11. Concurrent use of body-worn medical electronic devices. 12. No pre-existing or historical conditions which may impact the outcomes of this study (e.g abnormal cx smear) 13. Planned overseas travel for the duration of the study 14. Unable to comply with the study protocol 15. Require X-rays or other medical scans for the duration of the study |
| Date of first enrolment | 12/09/2024 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Liverpool
L1 4A
United Kingdom
2 Ellison Grove, Huyton
Liverpool
L36 9GA
United Kingdom
Birmingham
B18 6HN
United Kingdom
London
NW1 6BY
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Southampton
SO16 5YA
United Kingdom
Sponsor information
Industry
115B Innovation Drive, Milton
Abingdon
OX14 4RZ
England
United Kingdom
| Website | https://www.versobiosense.com/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data- sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
18/06/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
