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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-525005-20-00

Enrollment

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Brief summary

The primary endpoint of the study will be the evaluation of sperm concentration (Ml/ml) on the last day of treatment (week 16) compared to the untreated arm

Interventions

DRUGGONASI HP 250 U.I. / 1 ml polvere e solvente per soluzione iniettabile

DRUGGONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen

Eligibility

Sex/Gender

Male

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study will be the evaluation of sperm concentration (Ml/ml) on the last day of treatment (week 16) compared to the untreated arm	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026