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Follitropin Alfa and Chorionic Gonadotrophin for Men with Male Infertility, Low Testosterone, and Low Sperm Count

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying Male Infertility in men with a low sperm count, low testosterone levels, and normal FSH levels, where FSH is a hormone that helps control sperm production. The study will use two medicines: follitropin alfa, also called GONAL-f, and chorionic gonadotrophin, also called GONASI HP. The purpose of the study is to see whether using these medicines together can help improve sperm concentration compared with no treatment.

Men in the study will be assigned to receive either the medicine combination or no treatment. The treatment period lasts about 16 weeks. During this time, the medicines are given by injection, with follitropin alfa given under the skin and chorionic gonadotrophin given into a muscle. The study then compares sperm concentration at the end of treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment period

    After joining the study, you enter a treatment period that lasts 16 weeks.

    During this period, you receive GONAL-f (follitropin alfa), which is given as a subcutaneous injection under the skin at a dose of 150 IU once daily.

    During this period, you also receive GONASI HP (chorionic gonadotrophin), which is given as an intramuscular injection into a muscle at a dose of 500 IU once daily.

    The treatment continues for the full 16 weeks unless the study plan changes.

  2. Step 2

    End of treatment assessment

    On the last day of treatment, at week 16, your sperm concentration is measured.

    Sperm concentration means the number of sperm cells in a given amount of semen.

Who can join the trial?

10 criteria

  • Be a man between 18 and 55 years old.
  • Have a body mass index (BMI) of less than 35 kg/m². BMI is a measure of body weight compared with height.
  • Have had male infertility for at least 12 months. Infertility means not being able to cause a pregnancy after regular unprotected sex for a year or more.
  • Have a sperm concentration between 1 million/mL and 16 million/mL at screening. Sperm concentration means the number of sperm in a given amount of semen.
  • Have normal FSH levels at screening, between 1.5 and 8 IU/mL. FSH is a hormone that helps control sperm production.
  • Have normal LH levels at screening, at least 1.5 IU/mL. LH is a hormone that helps the body make testosterone.
  • Have low testosterone levels at screening, between 210 and 350 ng/dL (or 7.3 to 12.1 nmol/L). Testosterone is a hormone important for male reproductive health.
  • Have normal prolactin and normal thyroid-stimulating hormone (TSH) levels in a local laboratory test. Prolactin and TSH are hormones measured in blood tests.
  • Have not used gonadotropins, aromatase inhibitors, or SERMs for at least 3 months before screening. These are medicines that affect hormone levels and sperm production.
  • Have no clinically significant abnormal findings in blood tests, urine tests, or other screening tests. This means the screening tests should not show important health problems.

Who cannot join the trial?

9 criteria

  • Genetic mutations known to cause abnormal sperm count, such as Y chromosome microdeletions (small missing parts of the Y chromosome) or CFTR gene mutations (changes in a gene linked to certain inherited conditions).
  • Signs of testicular inflammation or infection, or signs of blockage in the testicles. This also includes a testicular volume greater than 25 mL on ultrasound, which may suggest abnormal enlargement.
  • Clinical varicocele at any grade, meaning enlarged veins around the testicle that can be seen or felt by a doctor.
  • An uncontrolled chronic disease during screening or while in the study, meaning a long-term illness that is not well managed or has active flare-ups. Examples include diabetes, thyroid disorders (problems with the gland that controls body metabolism), autoimmune diseases such as arthritis, vasculitis (inflammation of blood vessels), or inflammatory bowel disease.
  • Active cancer at the time of screening.
  • A history of gonadotoxic treatments, meaning treatments that can harm the testes and reduce sperm production, such as some chemotherapy or radiation treatments.
  • Use of testosterone therapy at any time during the 12 months before screening.
  • A history of anabolic steroid use, meaning use of muscle-building steroids.
  • Having only one testicle.
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Investigated drugs

  • GONAL-f

    is a medicine that contains follitropin alfa, which is a form of follicle-stimulating hormone. In this trial, it is used to help stimulate the testes to support sperm production in men with low sperm count and low testosterone.

  • GONASI HP

    is a medicine that contains chorionic gonadotrophin, also called hCG. In this trial, it is used to help the testes make more testosterone, which may work together with the other study medicine to improve sperm production.

What is already known about the treatment

  • Chorionic gonadotrophin

    Chorionic gonadotrophin is given as a solution for injection, usually by intramuscular injection, and in this trial it is used as an active treatment for male infertility. It is still an established medicine in clinical practice and medical literature, especially for hormone-related fertility care. It is classified as a gonadotropin and works by acting like luteinizing hormone, which signals the testes to make more testosterone and support sperm production at the testicle level.

  • Follitropin alfa

    Follitropin alfa is a solution for injection that is given under the skin, often with a pre-filled pen, and it is used here to help improve sperm concentration in men with infertility. It is a well-known recombinant medicine that remains widely used in fertility treatment and is well described in medical literature. It belongs to the follicle-stimulating hormone group and works by binding to FSH receptors on testicular cells, helping the testes support sperm development and improve sperm production.

Investigated diseases

Male infertility - Male infertility is a condition in which a man has reduced ability to cause pregnancy, often linked to problems with sperm production, sperm movement, or sperm quality. It may develop gradually and can be related to hormonal changes, testicular problems, or blockage in the reproductive tract. In some men, sperm count is low, sperm may be weak or abnormal, or semen analysis may show reduced fertility potential. The condition can remain stable or worsen over time depending on the underlying cause.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525005-20-00Protocol codeMATES StudyEstimated enrolment138 patientsSponsorMartin-Luther-Universitaet Halle-Wittenberg

sourced from the EU Clinical Trials Register and site verification

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