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NAPO - Novel Approach for Oligospermia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508325-27-00
Enrollment
60
Registered
2023-12-19
Start date
2024-04-01
Completion date
2025-01-27
Last updated
2023-12-19

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

Conditions

Male infertility

Brief summary

Difference in sperm cell concentration (sperm cell concentration millions/mL) between the two groups, evaluted by the semen sample delivered at day 80

Detailed description

Difference in semen quality between the intervention group and the placebo group (total number of sperm cells, and total and percentage of motile, progressive motile and morphological normal sperm cells), evaluated by semen sample delivered at day 80 compared with baseline, Difference in spontaneous pregnancies before day 180, Difference in number of spontaneous abortions during the whole trial, Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80, Changes in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80 within the groups

Interventions

Sponsors

Herlev Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Difference in sperm cell concentration (sperm cell concentration millions/mL) between the two groups, evaluted by the semen sample delivered at day 80

Secondary

MeasureTime frame
Difference in semen quality between the intervention group and the placebo group (total number of sperm cells, and total and percentage of motile, progressive motile and morphological normal sperm cells), evaluated by semen sample delivered at day 80 compared with baseline, Difference in spontaneous pregnancies before day 180, Difference in number of spontaneous abortions during the whole trial, Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80, Changes in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80 within the groups

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026