RecruitingPhase IInterventional

Study to investigate the temperature and dissolved oxygen levels in the uterine cavity of females with normal menstrual cycles

This study aims to understand the temperature and oxygen levels inside the womb of women who have regular menstrual cycles. Researchers will use a small monitoring device, called the IRIS system, which is placed inside the womb for just seven days. The goal is to collect important information that could lead to better ways to understand and treat women's reproductive health in the future. Participants will be women aged 18-42 with regular periods. There are some risks, like discomfort or a small chance of injury during device insertion, but measures are taken to reduce these. Participants will be compensated for their time.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Verso Biosense Limited

Enrolment target

Start

12 Sep 2024

Estimated completion

15 Sep 2026

Reproductive health

What is this study about?

This research study is trying to learn more about the inside of a woman's womb. Specifically, it wants to measure the temperature and how much oxygen is present within the womb during different stages of a woman's natural monthly cycle. Think of it like taking the temperature and checking the air quality of a room to understand its environment better.

To do this, the study uses a unique, small monitoring device called the IRIS system. This device is placed gently inside the womb for only seven days. The information it collects will be incredibly valuable. Wwe don't currently have much data on these specific conditions inside the womb, and understanding them better could open doors to better treatments and support for women's health down the line.

The main reason this research matters is that a healthier womb environment could be key to many aspects of women's reproductive well-being. By gathering this new information, the study hopes to pave the way for innovations that could one day help women make more informed decisions about their health and lead to more effective care.

Key takeaways

Understanding womb temperature and oxygen could improve women's health treatments.
A small monitoring device is used for only seven days.
Participants receive £700 for their involvement.
The study involves women aged 18-42 with regular periods.
Risks are similar to other womb devices, with precautions taken.
Your contribution helps advance important women's health research.

Who may be eligible?

This study is looking for women who are between 18 and 42 years old and have regular menstrual cycles, meaning their periods usually come every 21 to 35 days. You should be generally healthy, with no major long-term illnesses like diabetes, and have a Body Mass Index (BMI) between 20 and 27.

There are certain reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to get pregnant soon, you can't take part. You also can't be using hormonal birth control or have had certain womb conditions or issues with previous pregnancies. If you have any major health issues, allergies to specific materials, or medical conditions that could interfere with the study or place you at risk, you would likely not be eligible. The study also cannot accept participants who need X-rays or other medical scans during the study period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 18 and 42 years old?
Do you have regular monthly periods, typically every 21–35 days?
Are you generally healthy, without major long-term illnesses like diabetes?
Are you not currently pregnant, breastfeeding, or planning a pregnancy soon?
Are you able to use barrier contraception (like condoms) or avoid sex during the study month?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a screening appointment to check if you meet all the requirements. If you're eligible, you'll be enrolled into the study group. The main part involves having a small monitoring device, called the IRIS system, carefully placed inside your womb. This procedure is similar to fitting other common womb devices. The device will stay in place for just seven days. After these seven days, the device will be removed in another appointment. Throughout this time, you'll need to use barrier contraception, like condoms, or avoid sexual activity. You'll also be asked to attend follow-up appointments. The entire process, from your first screening to the removal of the device, will span a short period.

Potential risks and benefits

Participating in this study offers several potential benefits. You'll be contributing to very important research that aims to improve our understanding of women's uterine health, which could lead to better future treatments and empower women to make more informed decisions about their well-being. You will also receive compensation of £700 for your time, travel, and the procedures involved. However, it's important to be aware of potential risks, similar to those with other devices placed in the womb. These can include mild discomfort or pain during insertion, some light bleeding, and a small risk of infection (about 2 in 1000). There's also a very rare chance of injury to the womb, such as a small hole (about 2 in 1000). To reduce risks, the device will be inserted under ultrasound guidance, and pain relief options are available. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Liverpool University Hospitals
Approximate
Liverpool, England
Liverpool University Hospitals
Approximate
Liverpool, England
Clarewell Clinics Birmingham
City only
Birmingham, England
Clarewell Clinics London
City only
London, England
Blackpool Teaching Hospitals NHS Foundation Trust
City only
Blackpool, England
Princess Anne Hospital
Approximate
Southampton, England

Common questions

What is the main goal of this study?

The study aims to measure temperature and oxygen levels inside the womb to better understand women's reproductive health.

How long will the device stay in my womb?

The small monitoring device will only stay in your womb for seven days.

Will I get paid for taking part?

Yes, you will receive £700 to cover your time, travel, and the study procedures.

Are there any risks to consider?

Potential risks include discomfort or pain during insertion, light bleeding, and very rare chances of infection or womb injury. Measures are taken to minimise these risks.

Who can join this study?

Women aged 18-42 with regular periods who are otherwise healthy and meet specific criteria.

How to find out more

Mariea Parvaz

m.parvaz@versobiosense.com +44 (0)7785465955 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.