SYFd8a95548ef314413ae9263d4de68293bRegistry ID: 2025-525005-20-00|Not Yet RecruitingPhase 4
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interventional
N/A
3 countries
7
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2026
Actual (reported)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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
Named ingredient: follitropin alfa
View registry recordUniversitaetsklinikum Muenster AöR
Muenster, 48149, Germany
Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), 06120, Germany
Justus-Liebig-Universitaet Giessen
Giessen, 35392, Germany
Benedetta Porro
First Submitted
January 30, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
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Azienda Sanitaria Locale Roma 2
Rome, 00157, Italy
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Ivi Valencia S.L.
Valencia, 46015, Spain
Ivi Madrid S.L.
Madrid, 28023, Spain