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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 Normai FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative
EU CTIS ID: 2025-525005-20-00
What this study is testing
To assess the impact of the combined administration of r-hFSH-alfa originator plus hCG compared to no treatment on sperm concentration in men with lowered semen analysis, low testosterone serum levels and normai FSH serum levels.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male with an age ≥ 18 years old ≤ 55 years old
- BMI < 35 kg/m2
- Male infertility of at least 12 months (ICMART definition)
- Sperm concentration ≥ 1 million/ml and ≤ 16 million/ml at screening
- Normal FSH serum levels (1.5-8 IU/mL) at screening
- Normal LH serum levels (at least 1.5 IU/ml) at screening
You likely can't join if
- Diagnosed genetic mutations responsible for abnormal sperm concentration (e.g., YCMD, CFTR gene mutations)
- Signs of testicular inflammation and or infection, as well as signs of obstruction (including testicular volume higher than 25 mL at ultrasound examination)
- Patients with clinical varicocele (any grade)
- At Screening and during the study period the presence of an uncontrolled chronic disease (ongoing acute episodes or inadequate treatments), such as diabetes mellitus, thyroid disorders, autoimmune diseases such as arthritis, vasculitis or inflammatory bowel disease
- Presence of active malignancies
- Patients with history of gonadotoxic treatments
See the full eligibility criteria
- Male with an age ≥ 18 years old ≤ 55 years old
- BMI < 35 kg/m2
- Male infertility of at least 12 months (ICMART definition)
- Sperm concentration ≥ 1 million/ml and ≤ 16 million/ml at screening
- Normal FSH serum levels (1.5-8 IU/mL) at screening
- Normal LH serum levels (at least 1.5 IU/ml) at screening
- Low testosterone serum levels (between 210 and 350 ng/dL, corresponding to 7.3-12.1nmol/L) at screening
- Normal serum prolactin and thyroid-stimulating hormone (TSH) values as measured in a local lab
- Have not received gonadotropin, aromatase inhibitors and SERMs at least 3 months before the start of screening
- No clinically significant abnormal findings in the screening haematology, biochemistry, and urinalysis parameters
- Diagnosed genetic mutations responsible for abnormal sperm concentration (e.g., YCMD, CFTR gene mutations)
- Signs of testicular inflammation and or infection, as well as signs of obstruction (including testicular volume higher than 25 mL at ultrasound examination)
- Patients with clinical varicocele (any grade)
- At Screening and during the study period the presence of an uncontrolled chronic disease (ongoing acute episodes or inadequate treatments), such as diabetes mellitus, thyroid disorders, autoimmune diseases such as arthritis, vasculitis or inflammatory bowel disease
- Presence of active malignancies
- Patients with history of gonadotoxic treatments
- Patients that received testosterone therapy at any time during the previous 12 months of the study screening
- Patients with a history of anabolic steroid use
- Patients with one testis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.