A 12 week, Randomized, Double-blind, Active-controlled Clinical Trial for - Evaluation of the Efficacy and Safety of GF101 on - Reproductive Function and - Antioxidant Activity of Infertility Subject

Biomlogic0 个研究点目标入组 160 人开始时间: 待定最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•1) Those who are 20 years old or older and 50 years old or younger
•2) Those with a body mass index (BMI) greater than 18 kg/m2 and less than 30 kg/m2
•3) Those who meet the following criteria
•(1) Female: Those who are expected to undergo IVF treatment
•(2) Males: Males who want to become pregnant and those who are currently undergoing artificial insemination or in vitro fertilization and who do not meet the 2010 WHO standards in semen analysis - Ejaculated volume: 1.0 mL or more Possible) A person who meets any of the following (less than 100% of the WHO 2010 standard)
•? Sperm count: 0 (exceeding) ~ 15x106/mL
•? Motility: 0 (exceeding) ~ 40 %
•? Strict morphology: <4 %
•4) A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

•1) Those with uncontrolled endocrine disease or medical disease
•2) Those who smoked excessively within 3 months based on Visit 1 (=10 cigarettes/day)
•3) Those who consumed excessive alcohol within 3 months of Visit 1 (=340 g/week, about 7 bottles/week of soju, 1 bottle/day) or alcoholics
•4) Women with moderate gynecological diseases (if there is a change in the uterine lumen due to endometriosis, submucosal fibroids, and polyps, pelvicitis, uterine malformations, hydrops of the fallopian tubes) You can participate if it is not related to infertility.)
•5) Men with Seminal duct obstructuion
•6) Men who need TESE/TESA implementation
•7) Those who are receiving other auxiliary treatment (oriental medicine treatment, etc.) for the purpose of infertility treatment
•8) Those who are judged inappropriate by the investigator for other reasons

发起方

Biomlogic