Randomized Trial of Follitropin Alfa Plus Chorionic Gonadotrophin for Male Infertility in Men With Oligozoospermia, Low Testosterone, and Normal FSH Levels

The primary objective is to evaluate whether combined administration of r-hFSH-alfa and hCG increases sperm concentration compared with no treatment in men with oligozoospermia, low testosterone, and normal FSH serum levels. This outcome is clinically relevant because sperm concentration is a key parameter of male fertility assessment. The secondary objectives are to assess effects on additional semen parameters, including total sperm count, total motile sperm count, percentage of progressively motile sperm, and normal sperm morphology; to evaluate DNA Fragmentation Index; to examine changes in hormonal values; and to determine the safety and tolerability of the combined treatment compared with no treatment.

The trial population consisted of male infertility patients aged 18 to 55 years with a body mass index below 35 kg/m2. The sponsor did not provide the total number of participants. Participants were selected from men with infertility of at least 12 months, lowered semen analysis, sperm concentration between 1 million/ml and 16 million/ml at screening, normal FSH and LH serum levels, low testosterone serum levels, and normal prolactin and thyroid-stimulating hormone values. Additional selection requirements included no recent use of gonadotropin, aromatase inhibitors, or SERMs within 3 months before screening, and no clinically significant abnormalities in screening haematology, biochemistry, or urinalysis. Lifestyle considerations such as diet, physical activity, or habits were not provided.

This multicenter randomized controlled trial evaluates the efficacy and safety of recombinant human follicle-stimulating hormone plus human chorionic gonadotropin compared with no treatment in men with male infertility, oligozoospermia, low testosterone, and normal FSH serum levels. The study duration is 16 weeks of treatment, with overall trial conduct extending from the planned recruitment start in February 2026 to the planned end in June 2028. The sequence of study visits includes a screening visit to assess eligibility criteria, including age, body mass index, semen parameters, hormone values, prior treatment exposure, and laboratory safety tests. Eligible participants then enter the treatment period and undergo follow-up visits during the 16-week study course to assess efficacy and safety, with the primary assessment performed on the last day of treatment at week 16. An end-of-study visit is conducted at completion of the treatment period. Participant involvement is expected to last up to 16 weeks. Early termination from the study may occur if eligibility criteria are not met, if clinically significant abnormalities are identified, or if prior prohibited treatments have been received within the specified period.

The experimental treatment consisted of follitropin alfa administered as a solution for injection in a pre-filled pen at a dose of 150 IU by subcutaneous injection. The study also included chorionic gonadotrophin administered as a solution for injection at a dose of 500 IU by intramuscular injection. The combined administration of recombinant human follicle-stimulating hormone alfa and human chorionic gonadotropin was evaluated against no treatment. No additional treatment arms were specified. Information on dosing frequency, treatment duration, and compliance monitoring was not provided.

Efficacy will be assessed by evaluating sperm concentration (Ml/ml) on the last day of treatment, at week 16, in the treated arm compared with the untreated arm.