AuthorisedTherapeutic use (Phase IV)Interventional

A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative

This research trial is for men who are experiencing male infertility, specifically those with a low sperm count (oligozoospermia) and low testosterone levels, but normal levels of another hormone called FSH. Researchers want to see if two different hormone medications, GONASI HP and GONAL-f, can help increase sperm concentration. The trial compares how these treatments affect sperm count after 16 weeks compared to not receiving treatment. It's a 'Phase IV' study, meaning the medicines are already approved, but researchers are gathering more information on their use for this specific condition. The aim is to find effective ways to improve fertility for men facing these challenges.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Martin-Luther-Universitaet Halle-Wittenberg

Enrolment target

138

Start

18 May 2026

Male Infertility

What is this study about?

This research study is looking into new ways to help men who are struggling with fertility. Specifically, it's for men who have a lower than usual number of sperm (doctors call this oligozoospermia) and also have low levels of the male hormone testosterone. It's important to note that the men in this study still have normal levels of another hormone called FSH, which is also involved in making sperm.

The study wants to find out if certain hormone treatments can boost a man's sperm count. The treatments being tested are called GONASI HP and GONAL-f. These medicines are already approved for medical use, but this study is specifically looking at how they work to improve fertility in this particular group of men. By doing this research, doctors hope to gain a better understanding of how to help men increase their chances of starting a family.

The main goal of the study is to see if, and how much, these hormone treatments can increase sperm concentration (the number of sperm in a given amount of fluid) after about 16 weeks of treatment. They will compare the results of men receiving the treatment to those who don't. This will help doctors understand if these specific hormone therapies are effective and safe for this group of men.

Key takeaways

Targets men with low sperm count and low testosterone.
Tests hormone treatments (GONASI HP and GONAL-f) to increase sperm.
Compares treated men to an untreated group over 16 weeks.
Aims to improve fertility options for men.
Medicines are already approved for other uses (Phase IV study).

Who may be eligible?

This study is designed for men who are at least 18 years old. There is no upper age limit for taking part.

To be considered for the study, you would need to have been diagnosed with male infertility. Specifically, this means you have a low sperm count, also known as oligozoospermia.

Another key requirement is that you must have low testosterone levels, but your levels of a different hormone called FSH should be within the normal range. The research team will carry out specific tests to check if you meet all of these criteria.

Quick self-check

Are you a man at least 18 years old?
Have you been told you have a low sperm count?
Have you been diagnosed with low testosterone levels?
Do you have normal levels of a hormone called FSH?
Are you willing to have regular clinic visits and take study medication if assigned?

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, the research team will explain everything to you in detail. You'll likely have regular visits to the clinic over a period of about 16 weeks (around 4 months). During these visits, you'll have various assessments, which will include blood tests to check your hormone levels and regular semen analyses to measure your sperm count.

You will receive one of the study medications, GONASI HP or GONAL-f, which are given as injections. The clinic staff will teach you or a caregiver how to give these injections. You'll be closely monitored throughout the treatment period to see how you're responding and to make sure you're doing well. After the 16 weeks of treatment, there might be follow-up appointments to track your progress.

Potential risks and benefits

Potential benefits of taking part could include gaining access to new treatments that might improve your sperm count and potentially your fertility. You would also be contributing valuable information that could help other men with similar conditions in the future. As with any medication, there are potential risks and side effects, which the study team will discuss with you in full. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

—
Italy
—
Spain
—
Germany

Common questions

What is male infertility?

Male infertility means a man has problems that prevent him from getting a woman pregnant, often due to issues with sperm production or function.

What are low sperm count and low testosterone?

Low sperm count means having fewer sperm than normal in your semen. Low testosterone means your body isn't making enough of the main male hormone, which is important for many body functions, including sperm production.

Will I definitely get the active treatment?

This is a 'randomised controlled trial', meaning you might receive the active hormone treatment or a comparison (untreated) approach. The study team will explain how this works.

How long will the treatment part of the study last?

The main treatment period in this study is planned for 16 weeks, which is about 4 months.

Will this study guarantee that I can have children?

No study can guarantee a specific outcome for every participant. The aim is to investigate if these treatments can improve sperm count, which may then improve your chances of conceiving.