Real time monitoring of the womb environment using a novel device
| ISRCTN | ISRCTN10654279 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10654279 |
| IRAS number | 263353 |
| Secondary identifying numbers | CPMS 44566, IRAS 263353 |
- Submission date
- 29/03/2021
- Registration date
- 31/03/2021
- Last edited
- 24/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Doctors and researchers at the University of Southampton have developed a novel monitoring device that may in the future be offered to women who have problems becoming pregnant or who have recurrent miscarriages.
A small sensor device developed by Verso Biosense in collaboration with the University has the potential to monitor the environment inside the womb to detect changes in oxygen levels, acidity, and temperature, which are features considered to have an impact on embryo development. The purpose of this study is to determine how acceptable the insertion of this device is to women and whether the collection of information is successful.
Who can participate?
Women aged between 18 and 42 years recruited from subfertility/gynaecology outpatients clinic with or without reproductive disorders and no known chronic illnesses
What does the study involve?
The study involves having a device placed within the womb in an outpatient clinic in a sterile environment for up to 7 days. The device is designed to look like an intrauterine contraceptive device, for trained health care professionals to place into the uterus. It has an accompanying garment which the patient can wear as pants, and a detachable rechargeable reader, which together provides the means of powering the device, communicating signals, and retaining data. A member of the research team will provide comprehensive instructions around the use of the device and how the study will be conducted. Regular follow-up phone calls and user experience interviews will be part of the study.
What are the possible benefits and risks of participating?
It is not known how the device will impact humans, but previous animal studies have shown localised inflammatory reactions in the lining of the womb. However, it should be noted that the device shape and dimension has been designed specifically for the human and not animals. It is anticipated that the risks in taking part in this study to be comparable to that of a contraceptive device inserted inside the womb, as it carries the same shape, dimension, and features.
The common risks of the device are pain, discomfort and mild bleeding on insertion/removal, and infection. The pain and discomfort in most cases will be short-lasting and the participants 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 will be treatable with antibiotics.
Less common risks include injury to the womb or expulsion of the device. The device will be inserted under ultrasound guidance, so the risk of injury to the womb will be rare. If the device does fall out, participants are advised not to worry and to contact the research team, who will be able to support them with what they should do next. Very rarely, the device removal cords retract into the womb and their doctor may be required to use specialised equipment in an outpatient setting including a camera to assist with its removal. During the study period and whilst the device is inside the womb, they will need to use barrier contraception or abstain from sexual intercourse, as it is important that they do not get pregnant whilst the device is in.
The participants will be reimbursed for travel and parking costs related to attending this research study. But they will not directly get any personal benefit from taking part in this trial. However, they will be helping the development of a new test which in the future may be offered to women having problems conceiving or who have recurrent miscarriages.
Where is the study run from?
University of Southampton (UK) and Princess Anne Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2019 to May 2022
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof Ying Cheong, Y.Cheong@soton.ac.uk
Contact information
Scientific
University of Southampton
Coxford Road
Southampton
SO16 5YA
United Kingdom
 ORCID ID |
0000-0001-7687-4597 |
|---|---|
| Phone | +44 (0)2381206033 |
| Y.Cheong@soton.ac.uk |
Study information
| Study design | Non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | IntraUterine SENSing using a batteryless, wireless intrauterine platform (USENSE) |
| Study acronym | USENSE |
| Study objectives | To demonstrate the feasibility of a clinical trial, and the safe and effective use of the IRIS System with its target demographic across women with a spectrum of uterine receptivity |
| Ethics approval(s) | Approved 27/02/2020, HRA and HCRW (Health and Care Research Wales) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ; no telephone number available; approvals@hra.nhs.uk), ref: 20/SC/0056 |
| Health condition(s) or problem(s) studied | Monitoring intrauterine parameters linked to fertilization |
| Intervention | The study will use the IRIS System to investigate the feasibility to recruit to a study to investigate the biophysical profile of dissolved oxygen (DO), pH, and temperature within the uterus of women with subfertility and amongst controls. Patients scheduled for the insertion of IRIS IUMD in the outpatient clinic at Princess Anne Hospital at the Southampton University Hospitals NHS Foundation Trust and who meet the Inclusion/Exclusion criteria will be eligible for recruitment into the study. The Investigators will be required to complete Case Report Forms (CRFs) in which information about the participants, the data described below, and any Adverse Events will be recorded. The study will include 25 women attending the fertility/gynaecological outpatient clinics, with or without diagnosed reproductive disorders. Participants will be advised to take barrier contraception or abstained from intercourse in the menstrual cycle of the trial period. The device will be inserted as an outpatient procedure, with the position checked on ultrasound scan. Use of local anaesthetics can be applied by clinician digression and/or on patient request. Prior to insertion of the device, the uterine (womb) dimensions will be measured using a vaginal ultrasound scan. At insertion, a speculum will be inserted in a sterile manner, and cervix (neck of the womb). The device will be inserted with the aid of an introducer similar to the insertion of an intrauterine coil. The details of the insertion will be noted on the CRF. Once the device is inserted, the patient is observed for up to 30 minutes, and then discharged once the device is confirmed technically functioning and the patient has tolerated the procedure well. Patients will be given information and advice on possible side effects such as bleeding and pain, and an emergency phone contact before discharge. The clinician researcher will provide a phone call follow up every 2 days until the day of removal (up to 7 days) and enquire about a standard set of clinical questions set out in the CRF. In the event of any adverse events that requires device removal, or the participant chooses to discontinue the study, immediate arrangement will be made to remove the device in clinic or an appropriate clinical environment according to need. At removal of the device, an endometrial fluid and biopsy sample will be taken using the fine catheter (usually used for embryo transfer) and a sampler used for removing small amount of lining of the womb (again a procedure commonly perform in outpatients to examine the womb lining) respectively. The samples will be stored appropriately and later send for histological examination to check for inflammation. Once the device is removed, the researcher will arrange a follow up phone call 3 days after the removal. Any side effects or adverse events reported in the process of the study will be dealt with according to standard clinical care. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Clinical feasibility measured using the following: 1.1. Rate of recruitment and retention of participants from Investigator's notes between baseline and 10 days 1.2. Ease of device insertion measured at baseline, carriage for up to 7 days measured between baseline and 7 days, and ease of removal measured at 7 days 1.3. Use of the device in women with a spectrum of endometrial receptivity recorded at nurse telephone follow-up at 1, 3, 5, 7, and 10 days 2. Safety measured using the incidence of any device-related AEs that are within the acceptable limits defined by Vivoplex’s Risk Management File recorded at nurse telephone follow-up at 1, 3, 5, 7, and 10 days 3. Technical feasibility measured as the rate of successful temperature, pH, and dissolved oxygen data capture based on the schedule of data transmission of the device between baseline and 7 days |
| Secondary outcome measures | 1. Clinical safety measured from the presence or report of the following clinical side effects/adverse events between baseline and 10 days: 1.1. Evidence of clinically confirmed or suspected uterine/pelvic infection 1.2. Pelvic pain at or after insertion 1.3. Irregular vaginal bleeding 1.4. Device expulsion or perforation 2. Device usability measured from device-related AEs associated with use-error between baseline and 10 days 3. Technical safety measured using body temperature between baseline and 7 days |
| Overall study start date | 30/12/2019 |
| Completion date | 30/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 25; UK Sample Size: 25 |
| Key inclusion criteria | 1. Women recruited from the subfertility/gynaecology outpatients clinic with or without reproductive disorders 2. Aged between 18 and 42 years inclusive 3. Clinically suitable for insertion of device in outpatients 4. No chronic illness that influences fertility (such as diabetes or autoimmune disorders) 5. Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study 6. BMI <35 7. Able and willing to use barrier contraception or abstain from sexual intercourse in the menstrual cycle of the trial period |
| Key exclusion criteria | 1. Pregnant, lactating, or planning pregnancy during the course of the trial 2. Hormonal treatment 3. Any concomitant medical treatment for or has any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 4. Allergy to anaesthetics (where applicable), silicone, or barium sulphate 5. Current ongoing investigations of abnormal uterine bleeding 6. Current, ongoing, or recurrent vaginal or pelvic infection 7. Body-worn life-sustaining electronic devices. 8. Abnormalities within the reproductive tract prohibiting the safe insertion of an intrauterine device |
| Date of first enrolment | 22/07/2021 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mailpoint 18
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
Research and Innovation Services
Rm 2029
Building 28
Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)2380595058 |
|---|---|
| A.Knight@soton.ac.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/08/2021: The recruitment start date was changed from 01/04/2020 to 22/07/2021.
06/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2021 to 28/02/2022.
2. The overall trial end date was changed from 31/01/2022 to 30/05/2022.
29/03/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
