An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study to Evaluate the Efficacy and Safety of D-Frag Tablets in the Treatment of Sperm DNA Fragmentation in Adult Men to Aid Conception.

utri Synapzz Therapeutix Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male subjects above the age of 21 years, in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception.
•2. Subjects with Sperm DNA Fragmentation Index >=15% at the time of screening.
•3. Subjects with normal or clinically non-normal seminal parameters not limited to hemospermia, leucospermia.
•4. Subjects whose female partners have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
•5. Subjects with primary or secondary infertility.
•6. Subjects who are willing to commit to study restrictions not limited to abstinence from masturbation and sexual intercourse for specific periods.

•Subjects who have aspermia, azoospermia, cryptozoospermia.
•2. Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
•3. Subjects with testicular atrophy and congenital abnormalities not limited to absence of vas deferens.
•4. Subjects who are currently on or were on a antioxidant and/or vitamin supplements upto 3 months prior to screening.
•5. Subjects with history of substance abuse.
•6. Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
•7. Subjects with known history of clinically significant, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.
•8. Subjects who have undergone major surgical procedure 4 weeks prior to screening.
•9. Subjects who are on steroids, hormone therapy, anti-depressants, anti-psychotics.
•10.Subjects who have participated in another clinical study upto 3 months prior to screening.
•11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•12. Subjects who in the opinion of the investigator are deemed unfit to participate in the study.

发起方

utri Synapzz Therapeutix Private Limited