RecruitingPhase IInterventional

Study with the IRIS System to investigate intra-uterine temperature and intra-uterine oxygen levels, and the impact of sildenafil

This study is investigating temperature and oxygen levels inside the womb of women who have tried IVF but haven't gotten pregnant. Researchers want to better understand how a healthy womb works to help create new and improved fertility treatments in the future. Participants will have a small device placed in their womb for 7 days to collect information. They will also use a Sildenafil vaginal suppository for part of this time. The study aims to learn more about the womb's environment and how it might affect a woman's chances of getting pregnant. It's for women aged 18-42 who have had at least one IVF cycle without success.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Verso Biosense Limited

Enrolment target

Start

01 Jan 2024

Estimated completion

15 Dec 2026

Reproductive health

What is this study about?

This research study, called the IRIS System study, is looking into something very important for women who are trying to start a family. Specifically, it wants to understand more about the conditions inside the womb – like its temperature and how much oxygen is present. Researchers believe that these factors could play a big role in whether a woman can get pregnant. They are focusing on women who have undergone IVF (which stands for In Vitro Fertilisation) at least once but haven't yet become pregnant.

The main goal of this study is to gain a clearer picture of womb health. By carefully measuring temperature and oxygen levels at different points in the menstrual cycle, scientists hope to learn more about what makes a womb a good place for a pregnancy to start. This understanding is crucial because it can help guide the development of brand-new ways to help women facing challenges with fertility.

Ultimately, the findings from this study could lead to better fertility treatments for many women in the future. By uncovering more about the intricate environment within the womb, researchers hope to improve the chances of successful pregnancies for those who have found it difficult to conceive.

Key takeaways

Aims to understand womb temperature and oxygen levels.
For women aged 18-42 who haven't conceived after IVF.
Involves a small womb device and Sildenafil suppositories.
Could help develop future fertility treatments.
Study runs from January 2023 to December 2026.

Who may be eligible?

This study is for women aged between 18 and 42 years old. To be able to take part, you must have tried IVF at least once before, but haven't yet become pregnant. You also need to be generally healthy, without certain long-term illnesses like diabetes, and have a body mass index (BMI) between 20 and 27.

There are also some important things that would mean you can't join the study. For example, you can't be pregnant, breastfeeding, or planning to get pregnant during the study period. You also shouldn't be taking certain hormone treatments, have had many miscarriages, or have ongoing untreated infections or certain womb problems previously identified by a doctor. If you have a known allergy to sildenafil (the medicine used) or to certain materials in the small device, you also wouldn't be able to participate. You shouldn't be using any other medical electronic devices on your body.

It's important that you would be able to attend all appointments, understand what the study involves, and follow the instructions given to you, such as using contraception during the study month. The medical team will check carefully if the study is right for you.

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?
Have you had at least one IVF cycle without becoming pregnant?
Do you have a healthy BMI (between 20 and 27)?
Are you generally healthy, without serious long-term illnesses?
Are you able to use contraception 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 be assigned to one of two groups. This depends on when in your menstrual cycle a small monitoring device is placed inside your womb – either between day 7 and 14, or between day 15 and 22. This device is similar to an intrauterine device (IUD) and will stay in place for 7 days to collect important information about your womb's temperature and oxygen levels.

From the fourth day after the device is put in, you will also start using a vaginal suppository (a small cone-shaped medicine inserted into the vagina) once a day. This suppository contains Sildenafil (100 mg). After 7 days, the monitoring device will be removed.

Over the course of the study, you'll have a few visits to the clinic for check-ups, the insertion and removal of the device, and to receive instructions. The team will carefully explain the full plan before you agree to take part, including the total expected duration of your involvement.

Potential risks and benefits

Taking part in this study might not directly benefit you, but the information found could be very valuable. It could help doctors and scientists learn more about womb health and potentially lead to better fertility treatments for other women in the future. As with any medical procedure or medicine, there are possible risks and discomforts. For example, inserting the device might cause some temporary discomfort, and the medicine (Sildenafil) could have side effects. All potential risks and side effects will be fully explained to you before you agree to join. Remember, you can always change your mind and withdraw from the study at any time without giving a reason.

Locations (1)

London Women's Clinic
Approximate
London, England

Common questions

What is IVF and why is it mentioned?

IVF stands for In Vitro Fertilisation, a common fertility treatment. This study focuses on women who have tried IVF but haven't gotten pregnant, to learn more about the womb's environment.

What is Sildenafil?

Sildenafil is a medicine, often known by brand names like Viagra. In this study, it's used in a vaginal suppository to see if it affects the womb's temperature and oxygen levels.

Will I become pregnant during the study?

No, this study is not designed to help you become pregnant. Because the device is in place, and for safety, you will need to use contraception or avoid sex during the study period.

How long will the device stay in my womb?

The small monitoring device will stay in your womb for 7 days to collect the necessary information needed for the study.

Where is the study taking place?

The study is being run from the London Women’s Clinic in the UK.

How to find out more

Mariea Parvaz

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

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