RecruitingOBSERVATIONAL

Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

This study is trying to understand more about a gene called CFTR, which plays a role in conditions like cystic fibrosis and certain types of male infertility. Researchers will use tiny samples from a part of the male reproductive system called the epididymis. These samples will come from men who are already having surgery for other reasons. The aim is to study how the CFTR gene works in these cells. By looking at these samples, scientists hope to learn more about why some men experience infertility and how this relates to conditions like cystic fibrosis. This research uses leftover tissue from your planned surgery and won't involve any extra procedures or affect your health.

At a glance

Status

Recruiting

Sponsor

University Hospital, Brest

Enrolment target

Start

11 Sep 2024

Estimated completion

11 Sep 2026

Cystic Fibrosis Congenital Bilateral Absence of Vas Deferens Sterility, Male

What is this study about?

This research is focused on understanding a specific gene called CFTR. This gene is known to be involved in conditions like cystic fibrosis, and changes in it can also lead to certain types of male infertility, such as when the tubes that carry sperm are missing (called bilateral agenesis of the vas deferens).

To study this, scientists need to look at cells from a part of the male reproductive system called the epididymis. They want to understand exactly how the CFTR gene is organised and controlled within these cells. By getting a clearer picture of this, they hope to better understand why these conditions develop and how they affect the body.

Ultimately, this research could lead to new insights into male infertility linked to these conditions. It's about building our basic knowledge of how the body works at a very detailed level, which is the first step towards better treatments or understanding in the future.

Key takeaways

This study uses epididymal samples from planned surgeries.
It aims to understand the CFTR gene's role in male infertility and cystic fibrosis.
Participation involves no extra procedures or health risks.
The research won't directly benefit you but could help future patients.
You must be a man over 18 and already scheduled for specific surgery.

Who may be eligible?

This study is looking for men aged 18 or older.

You might be able to take part if you are already scheduled for surgery where a small sample will be taken from your epididymis. This includes men who have cystic fibrosis, or a condition called bilateral agenesis of the vas deferens (where the tubes that carry sperm are missing), and are having this planned surgery. It also includes men who are having this surgery for other reasons, and don't have a known genetic condition.

You cannot take part if you are not already having this type of surgery, are under 18, or if you refuse to participate. Also, if a court has assigned someone to make decisions for you (like a guardian), you wouldn't be able to join this study.

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 man at least 18 years old?
Are you already scheduled for surgery that involves taking an epididymal sample?
Are you having this surgery for male infertility, cystic fibrosis, absent vas deferens, or another reason?
Are you willing to sign a consent form to allow your sample to be used?

Answer every question to see your result.

What does participation involve?

If you decide to take part, there is no extra procedure for you. During your planned surgery, the surgical team will collect the epididymal sample as they normally would. Any part of the sample that isn't needed for your treatment will then be used for this research. This means your participation will not involve any additional hospital visits, assessments, medication, or follow-up appointments related to the study. It also won't change the total duration of your surgery or recovery. Your involvement is simply allowing researchers to use leftover tissue from a procedure you're already having.

Potential risks and benefits

There are no direct benefits to you from taking part in this study, as it's basic research. However, your contribution could help scientists learn more about male infertility and cystic fibrosis, potentially benefiting future patients. There are no additional risks to your health because the sample used for research is leftover from a procedure you are already having. You are free to withdraw your consent at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Antoine VALERI
Verified postcode
Brest, France· Recruiting

Common questions

What is the epididymis?

It's a coiled tube located at the back of the testicle that stores and carries sperm.

What is the CFTR gene?

The CFTR gene provides instructions for making a protein that helps move salt and water in and out of cells. Problems with this gene can cause conditions like cystic fibrosis.

Will I have an extra surgery for this study?

No, the sample will be taken during surgery you are already scheduled to have. There will be no extra procedures.

Will this research help me directly?

No, this study is to gain general knowledge; it won't directly change your treatment or health.

Can I change my mind about taking part?

Yes, you can decide to withdraw from the study at any time without it affecting your medical care.

How to find out more

Antoine VALERI, MD,PhD

antoine.valeri@univ-brest.fr +33298347170 Official trial record

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