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

Takayama Erina0 个研究点目标入组 50 人开始时间: 2022年12月19日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(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.
•18-60 years old
•4) Threshold based on laboratory values.
•SDF rate of raw semen exceeds 16%.
•5) Written patient consent
•Written consent from the patient

•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.

发起方

Takayama Erina