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Clinical Trials in the EU / 2025-525005-20-00
Authorised Phase IV

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

2025-525005-20-00 · tracked via the Priya Life Science EU tracker
Sponsor
Martin-Luther-Universitaet Halle-Wittenberg
Sponsor type
Educational Institution
Therapeutic area
Reproductive and Urinary Physiological Phenomena
Decision date
18/05/2026
Enrollment target
138
Sites
Italy, Spain, Germany

Condition studied

Male Infertility

Investigational medicinal product(s)

GONASI HP 250 U.I. / 1 ml polvere e solvente per soluzione iniettabileGONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen

Eligibility

Age group
18-64 years
Sex
Male

Primary endpoint

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-525005-20-00 on CTIS ↗ ← All trials in the EU