A PROSPECTIVE, COMPARATIVE, DOUBLE ARM, OPEN LABEL CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DFRAG TABLETS Vs. LIFESTYLE MODIFICATION IN THE TREATMENT OF SPERM DNA FRAGMENTATION IN MARRIED ADULT MEN TO AID CONCEPTION
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 5
- 主要终点
- Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment.
研究概览
简要总结
Disorders of the male reproductive system are an important public health issue causing infertility, miscarriages, and abnormal outcomes in the offspring. It is well recognized that spermatozoa from infertile men often have multiple structural and functional defects (Mortimer et al., 1986; Aitken et al., 1991; Liu and Baker, 1994). In 20% of infertile couples, the problem is predominantly male, and in up to 40% of men with sperm abnormalities, no specific aetiological factor is found. Sperm DNA fragmentation (SDF) has been recognized as an important marker of sperm quality that can be used as a predictive factor for fertility in men. Elevated SDF may not only contribute to higher rates of failed fertilizations and spontaneous pregnancy loss, but it can also affect assisted reproductive techniques (ART).
This study is being conducted to make an objective assessment of the effectiveness of the intervention with nutritional supplementation with Dfrag tablets in adult Indian males in comparison to lifestyle modifications.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects between 21 -40 years of age (both ages included) in a monogamous heterosexual marriage.
- •2.Male subjects whose female partners have not conceived after more than year of unprotected vaginal intercourse with or without ART at the time of screening visit.
- •3.Male subjects with Primary or secondary infertility with a history of at least one of the factors listed below- a.Idiopathic b.recurrent pregnancy loss (≥2) c.recurrent IUI/IVF failure (≥2) 4.Male subjects with a history of any 2 factors listed below- a.Chronic alcohol use (a prolonged period of frequent, heavy alcohol use).
- •b.Current Smoker or cannabis smoking or tobacco use c.Obesity/overweight (BMI >25 kg/m2) d.Diabetes Mellitus 5.Male subjects with sperm DNA fragmentation index >15% 6.Male subjects with abnormal or non-normal semen analysis not limited to leucocyto-spermia (WHO 2010) 7.Male subjects who agree to commit to abstinence from sexual intercourse/ masturbation prior to collection of semen samples for analysis as required in the study.
- •8.Subject who voluntarily agrees to participation by signing the Ethics Committee approved informed consent form.
- •9.Subject can attend all scheduled visits and comply with the study procedures.
- •10.Subject has access to a telephone.
排除标准
- •1.Subjects who have aspermia, azoospermia, and cryptozoospermia 2.Subjects who have history/diagnosis of cancer inclusive of subjects who are in remission.
- •3.Subjects with testicular atrophy and congenital abnormalities not limited to absence of Vas deferens.
- •4.Subjects who are currently receiving antioxidants and/or vitamin supplements.
- •5.Subjects who were on antioxidants and/or vitamin supplements less than 60 days prior to screening (a gap of >60 days between last dose and screening is allowed) 6.Subjects with diagnosis of HIV, HBV, HCV, and other sexually transmitted disease.
- •7.Subjects with diagnosed varicocele.
- •8.Subjects with known history of clinically significant gastrointestinal, cardiovascular, hepatic, haematological, renal, respiratory, immunological, and neurological abnormalities, or disease 9.Subjects who have undergone major surgical procedure 4 weeks prior to screening 10.Subjects who are on anti-depressant, anti-psychotics, hormonal therapy, steroids.
- •11.Subjects who have participated in any other clinical trial ≤3 months prior to screening.
- •12.Subjects who are mentally unstable or cannot comprehend the responsibilities or adhere the protocol related stipulations.
- •13.Subjects who are deemed as unfit to participate in a study by investigator or any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
结局指标
主要结局
Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment.
时间窗: Baseline and 3 months post treatment.
次要结局
- 1.Changes in semen analysis including total sperm count and concentration, total and progressive motility between baseline and 3 months post treatment.(2.Changes in sperm morphology (% of normal forms) between baseline and 3 months post treatment.)
- The safety endpoints will be frequencies of treatment emergent adverse events. Safety endpoints will include all treatment emergent adverse events as observed during the study visits by the study team and/or reported by subject in the Subject Daily Diary Card (SDDC) or during telephonic follow-ups.(Baseline and 3 months)