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

Single-group controlled trial of the effect of Pregna use on sperm DNA fragmentation in male infertility patients - Pregna single group test

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210064
Enrollment
50
Registered
2021-09-02
Start date
2021-10-01
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, asthenozoospermia, malformation spermia, azoospermia, SDF rate 16% or more

Interventions

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 inge

Sponsors

Takayama Erina
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
SDF rate 3 months after administration

Secondary

MeasureTime frame
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

Contacts

Public ContactHiroki Takeuchi

Department ofObstetrics and Gynecology, 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