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Sperm DNA fragmentation single-group comparative study in patients using PQQ(Menicon)

A Single Group Study of the Effect of PQQ (Menicon) Administration on Sperm DNA Fragmentation in Male Infertile Patients - PQQ single group test

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220107
Enrollment
50
Registered
2022-12-19
Start date
2025-06-13
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Oligospermia, spermatasthenia, teratozoospermia, hyperspermia, or pyospermia

Interventions

Measure the SDF rate of original semen before and after taking the supplement "PQQ" in patients with poor semen findings, and investigate whether the SDF rate improves (decreases) after taking the sup

Sponsors

Takayama Erina
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Name of target disease and diagnostic method The following diseases were diagnosed by semen analysis, oligozoospermia (less than 75 million sperms/mL), spermatozoasthenia (less than 50%), teratozoospermia (more than 95%), hyperspermia (containing more than 1 million per ml of white blood cells), pyospermia (containing more than 1 million per ml of white blood cells), and so on. hypospermia (less than 2.0 mL) and pyospermia (contains more than 1 million per ml of white blood cells), etc. 2) Age 18-60 years old 3) Gender Male 4) Threshold based on laboratory values. SDF rate of raw semen exceeds 16%. 5) Written patient consent Written consent from the patient

Exclusion criteria

Exclusion criteria: 1) Patients who are taking supplements or drugs that have the same effect as the antioxidant compound within 3 months prior to the start of study drug administration 2) Patients with severe oligozoospermia, spermatogenesis disorders (hypothalamic/pituitary disorders, varicocele, cryptorchidism, azoospermia, chromosomal abnormalities (Klinefelter syndrome, etc.), impaired sperm passage (azoospermia obliterans, retrograde disorder), or abnormal accessory genital organ function 3) Patients with diarrhea, vomiting or allergy (to soy ingredients) to therapeutic drugs 4) Patients with serious liver disease (AST (GOT) or ALT (GPT) exceeds 100 IU/L) 5) Patients who have participated in other clinical trials (investigational clinical trial) leading to improvement of semen findings within 3 months prior to the start of administration of the study drug 6) Subjects who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator of the study.

Design outcomes

Primary

MeasureTime frame
Binary SDF rate at 3 months post-treatment, divided by SDF rate below 16% and exceeds 16%.

Secondary

MeasureTime frame
SDF change, SDF change rate, semen findings (fluid volume, total sperm concentration, motility rate, malformation rate, motility) Change = 3 months post-dose - pre-dose, Rate of change = (3 months post-dose - pre-dose)/pre-dose

Contacts

Public ContactHiroki Takeuchi

Mie University Graduate School of Medicine

fertility-repro@clin.medic.mie-u.ac.jp+81-59-232-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026