JPRN-jRCTs041210135招募中2 期
PDE5 inhibitor could improve human sperm motility: a randamized trial - PEOS study
Inoue Takahiro0 个研究点目标入组 20 人开始时间: 2022年1月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 50age old（—）
- 性别
- Male
入选标准
- •1) Patients complained infertility and diagnosed as oligospermia, asthenozoospermia.
- •normal range of human spermia in the institute (sperm volume > 2.0ml, sperm concentration >7500 x 10 5/ml, sperm motility >50.0%, sperm shape abnormality >50.0%, motility level A-C: A: proceed straightly quickly, B: proceed not straightly slowly, C: head or tail movement observed but not proceed), whuite blood cell <100 x10 5/ml, 2)male, 3) age 20 to 50 y.o.,
- •4) performance status 0-1, 5) patients who wish to give birth of baby and accept to be treated with fertility treatment, 6) obtained written inoformed
排除标准
- •1) Patients who use nitric acid drug which is contraindications for concomitant use.
- •2) Patients who have allergy for Tadalafil.
- •3) Patients who have past or present history of unstable angina, arrhythmia, hypertention.
- •4) Patients who have severe liver disease, show more than 100 IU/L of AST(GOT) or ALT(GPT).
- •5) Patients who have severe kidney disease.
- •6) Patients involved in another linical trial which started 5 years ago and lasted t3 months and test interventional treatment or target drug or patients who do not have 3 month interval after previous clinical trial.
- •7) Patients who took supplements that might effect on sperm findings including zinc,
- •vitamin E, vitamin D, Citrulline, L-arginine, L-carnitine, organic maca, Ginseng, Coenzyme Q10, Yam ingredient, oyster extract, Selnium) except for after 2 weeks of last
- •administration. Patients who are preffered to taking these ingredients everyday should be excluded. Below is the lists of foods that include standard daily intake of these
- •ingredients (zinc, vitamin E, vitamin D, Citrulline, L-arginine, L-carnitine, organic maca, Ginseng, Coenzyme Q10, Yam ingredient, oyster extract, Selnium) in 100g.
- •Zinc (standars daily intake, 10mg for adult male): oyster, wheat germ, salted bonito, paprika, Karasumi, Vitamin E (standars daily intake, 6.5mg for adult male): sencha, sunflower oil, almond, tang Xinzi, wheat germ, matcha, grape oil, safflower oil, rice bran
- •oil, chrysanthemum paste, sweetfish, soybean germ, hazelnut, corn oil, gyokuro tea,
- •margarine, the fastsy oil, mayonaise, monkfish, lashes, almond chocholate, peanut,
- •salmon suzuiko, rice bran, soybean oil, caviar, salmon roe, tang Xinzi, eel, Vitamin D
- •(standars daily intake, 5.5 mcg for adult male): arage jellyfish, salted bonito, liver of
- •monkfish, umazurahagi, dried shirasu, sand lance, dried fish seasoned with mirin, sardines, herring, tatami sardine, white salmon roe, filefish, black marlin, arage jellyfish,
- •grey mullet roe, Pink or humpback salmon, banded blue-sprat, sandeel, frigate tuna,
- •saury dried with mirin, eel, Citrulline : watermelon, melon, goji berry, cucumber, bitter melon, L-arginine (standars daily intake, 2000mg for adult male): watermelon, peanut,
- •egg white, L-carnitine(standars daily intake, 1000mg for adult male): lamb, mutton
- •meat, Coenzyme Q10 (standars daily intake, 100mg for adult male):, it needs 26 of
- •sardine or 3kg of beef, oyster extract: oyster, Selnium (standars daily intake, 30mcg for adult male): dried bonito, mustard, liver of monkfish, alaska pollack roe, raw bluefin, raw tuna, fried sunflower.
- •Candidates would be checked if they have these ingredients daily more than 100g. If they had taken them
- •to some extent or will be given as supplements, candidates should contact to investigator to receive
- •permission continuing the study.
- •Patients who had prescription and take midicine shown in below should beexcluded, because the main gredients are each of these supplements.
- •Pharmaceutical products for each gredients include NOBELZIN, JUVELA, ONEALFA,
- •ALPHA CALSIDOR, L-CARTIN FF, respectively.
- •8) Patients who were regarded as disqualified by representative or sharer doctor of
- •this study.
- •9) Patients who have been taking PDE5 inhibitor already.
- •10) Patients who have erectile dysfunction.
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