Sperm DNA fragmentation single-group comparative study in patients using pregna

JRCT ID: jRCTs041210064

Registered date:02/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oligospermia, asthenozoospermia, malformation spermia, azoospermia, SDF rate 16% or more
• Date of first enrollment: 01/10/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Measure the SDF rate of raw semen before and after ingestion of the supplement "Pregna (for women)" for patients with poor semen findings, and examine whether the SDF rate improves (decreases) by ingestion.

Outcome(s)

• Primary Outcome: SDF rate 3 months after administration

Secondary Outcome

SDF change amount, SDF change rate, semen findings (liquid volume, total sperm concentration, motility, malformation rate, motility)

Amount of change = 3 months after administration-before administration, rate of change = (3 months after administration-before administration) / before administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Male

Include criteria

1) Target disease name and diagnostic method
Those who have been diagnosed with oligospermia (less than 75 million animals / mL), asthenozoospermia (less than 50%), azoospermia (95% or more), azoospermia (less than 2.0 mL) or SDF rate of 16% or more.
2) Age
20-60 years old
3) Gender
male
4) Threshold based on clinical test values, etc.
SDF rate of raw semen is 16% or more
5) Written patient consent
Person with written consent from the person

Exclude criteria

1) Patients taking supplements or drugs that have the same effect as antioxidant compounds
2) Patients wtih severe oligospermia, spermatogenesis disorders (hypothalamus / pituitary disorders, varicocele, cryptorchidism, azoospermia, chromosomal abnormalities (Klinefelter syndrome), etc.), obstructive azoospermia , retrograde disorder, and accessory genital dysfunction
3) Patients with diarrhea, vomiting or allergies (containing soybeans) as therapeutic agents
4) Patients with serious liver disease (AST (GOT) or ALT (GPT) of 100 IU / L or more)
5) Patients who participated in other clinical trials (clinical trials) that lead to improvement of semen findings within 3 months before the start of study drug administration
6) Patients who are judged by the principal investigator or the investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Takayama Erina