Iris by Verso Biosense

We will perform an internal examination and an ultrasound. The device will be gently inserted into your uterus, similar to how an IUD is placed. You may experience mild discomfort, which will be recorded.

After the device is inserted, we will ensure it works correctly. You will be taught how to use the garment and data receiver and given a phone number for 24-hour support.

We will call you the following day after the device is inserted to check on you. We will ask if you have had any unusual symptoms and how comfortable you are with the device and garment.

After the device is inserted on day four, we will call you again to check on your condition and comfort. You will also be asked about any symptoms you may have experienced.

You will return to have the device removed between day seven and tenth. The procedure is simple and similar to removing an IUD. We will ask about your experience and any symptoms.

We will call you three days after the device is removed to ensure you are feeling well. We will ask about any symptoms and gather your feedback on the trial.

After the trial, you can provide feedback about your experience. Based on your preference, this interview can be done over the phone or in person.

Eligible participants are healthy women aged 42 with regular menstrual cycles who are not currently pregnant or menstruating and have no significant medical conditions that could affect the study results.

The study aims to gather data on uterine temperature and oxygen levels to improve the understanding of the uterine environment, which may enhance the success rates of fertility treatments like IVF in the future.

During the screening visit, the participant’s consent to participate will be checked, a urinary pregnancy test carried out, and the eligibility criteria confirmed. Demographic, menstrual, and gynecological history, as well as any concurrent medications, will be recorded. Vital checks, STI screen, and a clinical examination will be performed.

The device is inserted via a speculum examination with transvaginal ultrasound to ensure correct positioning. The device is inserted using a device inserter, similar to an intrauterine contraceptive coil. The process is documented, and any discomfort or technical issues are recorded.

You may experience mild cramping or discomfort during device insertion and removal. Painkillers such as paracetamol or ibuprofen can be taken prior to insertion, and local anesthetic options are available on request. Participants will report discomfort/pain scores on a scale of 1-10.

Avoid sexual intercourse during the study period to prevent pregnancy. Inform medical staff if you need MRI scans or X-rays, as the device is not suitable for use with these tests. Do not expose the data receiver to water.

If your contraceptive implant is difficult to feel, or others have tried to remove it and failed, then it is likely that your implant has been inserted too deep.

You may most likely have been told by a clinician if this is the case and that you will require a specialist to remove your implant.

These are telephone follow-ups on days 2 and 4 post device insertion. Participants are asked about abnormal vaginal bleeding, pelvic pain, infections, device expulsion, and garment comfort. Discomfort/pain scores are recorded. Participants confirm if they wish to continue with the trial.

On day 7-10, the device is removed using a pair of grasping forceps. The device and its components are sent for inspection. Participants are asked about any adverse events, discomfort, and their overall experience.

Common risks include mild discomfort, cramping, light bleeding, and a small risk of infection. Rarely, the device may displace or the removal cords may retract, requiring additional outpatient procedures.

Contact the research team immediately if you experience any side effects. They will provide support and instructions on what to do next.

Your data will be anonymized and securely stored. Only the research team will have access to your personal information, which will be used solely for research purposes and to improve future clinical studies.

Yes, all information collected during the study will be kept strictly confidential. Your data will be coded to ensure anonymity, and results will be published without identifying participants.

No, participation is entirely voluntary. You can withdraw from the trial at any time without providing a reason, and this will not affect your standard of care.

You are free to withdraw from the study at any time. If you withdraw, your standard of care will not be affected, and we may still use any anonymized data already obtained with your permission.

Yes, participants will be compensated for by £700 upon successful completion, plus a complementary STI screen and a Long-Lasting Contraceptive method of their choice if wishes to have one within six months post complition of the study.

Compensation is available for any injury caused by trial procedures, in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). This compensation covers injuries likely caused by any test or procedure received as part of the trial.

You can find more details about data protection and privacy on the Health Research Authority’s websites (www.hra.nhs.uk/information-about-patients/ and www.hra.nhs.uk/patientdataandresearch) or by contacting the sponsor’s Data Protection Officer via email at j.cefai@versobiosense.com or by phone at +44 (0) 2380 111 555.