NT-NOA - Novel Treatment of some men with Non-Obstructive Azoospermia Et klinisk interventionsforsøg
This study is called NT-NOA and is looking for a new way to help men who have a type of infertility called Non-Obstructive Azoospermia. This means they don't have any sperm in their ejaculate, not because of a blockage, but usually because their testicles aren't producing sperm properly. The study is testing two new medicines (Prolia and Femar) to see if they can help men produce sperm in either their ejaculate or from a small operation called TESE (Testicular Sperm Extraction). Researchers will compare sperm production before and after treatment, and also look at hormone levels and whether any pregnancies are achieved. The goal is to find better treatment options for men struggling to start a family due to this condition.
At a glance
What is this study about?
This study, called NT-NOA, is for men dealing with a specific type of infertility where no sperm can be found in their semen samples. This can be very distressing for men hoping to start a family. This condition is called Non-Obstructive Azoospermia, meaning the problem isn't a blockage, but rather the testicles aren't producing sperm in the usual way.
The researchers are testing two new medicines, Prolia and Femar, which are already used for other conditions, to see if they can help men with this type of infertility to produce sperm. They want to find out if these medicines can encourage the body to make sperm that can then be found in ejaculate (semen) samples or during a minor surgical procedure called TESE. TESE involves taking a tiny sample of tissue from the testicle to look for sperm directly.
The main aim is to see if, after about three months of treatment, sperm can be found that wasn't there before. They will also be looking closely at changes in hormone levels, how the testicle cells are behaving, and ultimately, whether any pregnancies occur. This research is important because it could lead to new and more effective treatments for male infertility, offering hope to many couples.
Key takeaways
- This study explores new treatments for a type of male infertility called Non-Obstructive Azoospermia.
- It tests two existing medicines, Prolia and Femar, to see if they can help men produce sperm.
- Participation involves taking medication, blood tests, semen samples, and a minor TESE procedure.
- The main goal is to see if sperm can be found after treatment, and to understand hormone changes.
- The study lasts about three months for the main treatment period.
- While there are potential benefits, there are also risks, and success isn't guaranteed.
Who may be eligible?
To join this study, you must be a man aged 18 years or older. There aren't any upper age limits mentioned, so older men might also be able to participate.
The study is specifically looking for men who have been diagnosed with Non-Obstructive Azoospermia, which means you've had tests that show no sperm in your ejaculate because your testicles aren't making them properly, rather than a blockage.
The study will also look at your general health to make sure it's safe for you to take part and use the medications being tested. Your doctor will discuss all the specific requirements with you.
- Are you a man aged 18 years or older?
- Have you been diagnosed with Non-Obstructive Azoospermia (no sperm in ejaculation, not due to a blockage)?
- Are you generally healthy enough to participate in a medical study and take new medications?
- Are you able to attend appointments and provide samples as required by the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive either Prolia injections or Femar tablets. Over the course of the study, you will have several appointments involving blood tests to check hormone levels and general health. You will also be asked to provide semen samples at certain times, specifically around day 14 and day 80 of the study, if you are able to.
A key part of the study will involve a procedure called TESE (Testicular Sperm Extraction) around day 90. This is a minor operation where a small piece of tissue from your testicle is taken to check for sperm. If you have had a TESE procedure in the past, the results from this study’s TESE will be compared to your previous one to see if the treatment has made a difference. The total duration of the main treatment and assessment period is around 90 days. There will also be follow-up to see if any pregnancies are achieved.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is Non-Obstructive Azoospermia?
It's a type of male infertility where the testicles don't produce enough sperm, or any sperm at all, not because of a blockage in the tubes.
What are Prolia and Femar?
These are medicines already used for different health conditions, which researchers are now testing to see if they can help with sperm production in infertile men.
What is TESE?
TESE stands for Testicular Sperm Extraction. It's a small surgical procedure where a tiny piece of tissue is taken from the testicle to look for sperm.
How long will the study last for me?
The main treatment and assessment period for the study is about 90 days, or roughly three months.
Will I definitely produce sperm if I join this study?
No, there's no guarantee. The study is designed to see if these new treatments *can* help, but it doesn't mean it will work for everyone.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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