RecruitingNAINTERVENTIONAL

Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care

This study focuses on endometriosis, a common condition where tissue similar to the womb lining grows outside the womb. Currently, there's no cure, and while hormone treatments help, they don't work the same for everyone. This is often because we don't fully understand how the condition works or how these treatments affect it, partly due to the lack of good models for studying it. Researchers are developing a new and improved laboratory model using human tissue. This model will try to copy how the womb lining behaves and responds to treatments. The goal is to use this model to predict which hormone treatments might work best for individual women. This could lead to more effective and tailored treatments, ultimately improving care for those living with endometriosis.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

Start

21 Jun 2024

Estimated completion

21 Mar 2028

Endometriosis

What is this study about?

Endometriosis is a common condition affecting many women, where tissue similar to the lining of the womb grows in other places, like the ovaries or fallopian tubes. This can cause pain and other symptoms. While there isn't a cure right now, doctors often recommend hormone treatments to help manage the symptoms. However, these treatments don't work the same way for everyone, and it can be hard to know which one will be most effective for a particular person.

One of the main reasons for this difficulty is that we don't fully understand why endometriosis happens or how all the hormone treatments work in detail. It's also challenging for scientists to study the condition in the lab because there hasn't been a really good way to mimic how the tissue behaves in the human body. This study wants to change that.

Researchers are working to create a new and much better laboratory model. They'll use special techniques to build a tiny, complex tissue model that closely acts like the lining of the womb. The hope is that this new model will allow scientists to test different hormone treatments more effectively. By doing so, they aim to predict which treatments might work best for an individual. This could lead to doctors being able to choose the most suitable treatment for each woman, making their care much more personal and effective.

Key takeaways

This study helps understand endometriosis better through laboratory research.
It aims to create a new model to test hormone treatments more effectively.
Participation involves donating tissue during an operation you're already having.
There are no direct personal medical benefits or added health risks.
Your contribution could lead to more personalised treatments for future patients.
You can withdraw at any time without impacting your medical care.

Who may be eligible?

This study is looking for women between the ages of 18 and 50. To take part, you must have previously used or be currently using hormonal contraception. You also need to be having an operation like a hysterectomy, hysteroscopy, or laparoscopy for either a common, non-cancerous gynaecological issue that doesn't affect your womb lining, or for endometriosis itself.

There are certain reasons why you wouldn't be able to join. For example, if you are pregnant, have been pregnant in the last three months, or are breastfeeding. You also can't take part if you have gone through menopause or have used certain non-steroid hormone treatments in the last three months. If you have a non-hormonal coil (like a copper coil), or a history of certain cancers (breast, ovary, womb, or cervix), or a specific genetic condition called Lynch syndrome, you would not be eligible.

Additionally, if you are under legal guardianship, are in prison, or have a Body Mass Index (BMI) outside the range of 18.5 to 30, you wouldn't be able to participate. You must also be signed up with French social security, as this study is based in France.

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 50 years old?
Have you used or are you currently using hormonal contraception?
Are you having a hysterectomy, hysteroscopy, or laparoscopy for a non-cancerous gynaecological issue or endometriosis?
Are you NOT pregnant or breastfeeding?
Do you NOT have a history of certain cancers (breast, ovary, womb, cervix) or Lynch syndrome?
Do you have a Body Mass Index (BMI) between 18.5 and 30?

Answer every question to see your result.

What does participation involve?

This study involves collecting a small sample of tissue during a planned surgical procedure you are already having (like a hysterectomy, hysteroscopy, or laparoscopy). You would not need any extra appointments or visits specifically for this study. The researchers will simply use the tissue that would normally be removed during your operation. There are no new medications to take or any follow-up appointments related to the study itself. The total duration of your involvement would generally be limited to the time taken to give your consent and for the tissue sample to be collected during your surgery.

Potential risks and benefits

There are no direct medical benefits to you from taking part in this study, as it only involves collecting tissue during an operation you are already having. However, your contribution could greatly help researchers understand endometriosis better and develop more effective, personalised treatments for others in the future. As the tissue collection happens during your planned surgery, there are no additional risks beyond those associated with your operation. You have the right to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (2)

Hôpital Femme Mère Enfant / GHE
Verified postcode
Bron, France· Recruiting
Hôpital de la Croix-Rousse / GHN
Verified postcode
Lyon, France· Recruiting

Common questions

What is endometriosis?

Endometriosis is a condition where tissue similar to the lining of the womb grows outside of it, causing pain and other symptoms.

What is this study trying to achieve?

This study aims to create a better lab model of endometriosis to help understand the condition and test how different treatments work.

Will I receive new treatment?

No, this study does not involve giving you any new treatments. It focuses on understanding endometriosis using tissue collected during your existing surgery.

Does taking part affect my surgery?

No, participating in this study will not change your planned surgery or medical care in any way.

Can I change my mind after agreeing to take part?

Yes, you are free to withdraw from the study at any time without having to give a reason, and it will not affect your medical care.

How to find out more

Charles-André PHILIP, M.D., PhD

charles-andre.philip01@chu-lyon.fr 04 27 85 51 70 Official trial record

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