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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1.Sperm DNA Fragmentation Index : Reduction of ≥5% DFI from baseline to end of study.
研究概览
简要总结
**StudyDesign:**An OpenLabel, Prospective, Non-Comparative, Single Arm Clinical Study.
**StudyPopulation:**Males abovethe age of 21 years in a monogamous, heterosexual marriage, trying to conceivebut having difficulty with conception.
**Indication:**Male Infertility (Sperm DNAFragmentation)
**Investigational Product Test:**DFrag Tablets
**InvestigationalProduct Comparator:**None.(Non-comparative, single arm study)
**Dosage:**1 BD x 3 months (1 tablet in themorning and 1 tablet in the night for 3 months)
**StudyDuration:**3 months
**Number ofSubjects:**66 subjects(so as to reach 60 evaluable subjects)
Assessments:
-
Sperm DNA Fragmentation Index
-
Subject IP Feedback Questionnaire
-
Complete Blood Count
-
Serum Biochemistry (including LFTand RFT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects above the age of 21 years, in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception.
- •Subjects with Sperm DNA Fragmentation Index ≥15% at the time of screening.
- •Subjects with normal or clinically non-normal seminal parameters not limited to hemospermia, leucospermia.
- •Subjects whose female partners have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
- •Subjects with primary or secondary infertility.
- •Subjects who are willing to commit to study restrictions not limited to abstinence from masturbation and sexual intercourse for specific periods.
排除标准
- •Subjects who have aspermia, azoospermia, cryptozoospermia.
- •Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
- •Subjects with testicular atrophy and congenital abnormalities not limited to absence of vas deferens.
- •Subjects who are currently on or were on a antioxidant and/or vitamin supplements upto 3 months prior to screening.
- •Subjects with history of substance abuse.
- •Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
- •Subjects with known history of clinically significant, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.
- •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.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects who in the opinion of the investigator are deemed unfit to participate in the study.
结局指标
主要结局
1.Sperm DNA Fragmentation Index : Reduction of ≥5% DFI from baseline to end of study.
时间窗: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
2.Sperm DNA Fragmentation Index : Reduction of ≥10% DFI from baseline to end of study.
时间窗: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
3.Sperm DNA Fragmentation Index : ≤15% DFI by end of study,provided that the reduction is ≥5% DFI.
时间窗: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
4.Subject Compliance and Satisfacation: Score of ≥ 20 by end of study.
时间窗: 1.Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90). | 2.Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
次要结局
- 1.Sperm DNA Fragmentation Index : Reduction of 3-4% DFI from baseline to end of study.(2.Subject Compliance and Satisfacation: Score of 15-19 by end of study.)