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

Sperm DNA fragmentation single-group comparative study in patients using pregna (Pregna single group test )

Takayama Erina

Mie university Hospital

2-174 Edobashi, Tsu

erina-t@med.mie-u.ac.jp

Takeuchi Hiroki

Department ofObstetrics and Gynecology, Graduate School of Medicine

2-174 Edobashi, Tsu

+81-59-232-1111

fertility-repro@clin.medic.mie-u.ac.jp

Not Recruiting

Sept. 02, 2021

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

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

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

Male

Oligospermia, asthenozoospermia, malformation spermia, azoospermia, SDF rate 16% or more

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.

SDF rate 3 months after administration

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

+81-59-231-5045

July. 26, 2021

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