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

JRCT ID: jRCTs041220107

Registered date:19/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oligospermia, spermatasthenia, teratozoospermia, hyperspermia, or pyospermia
• Date of first enrollment: 01/01/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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 supplement.

Outcome(s)

• Primary Outcome: Binary SDF rate at 3 months post-treatment, divided by SDF rate below 16% and exceeds 16%.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 60age old
• Gender: Male

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Takayama Erina