A PROSPECTIVE, COMPARATIVE, DOUBLE ARM, OPEN LABEL SINGLE CENTRE CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DFRAG TABLETS (FIXED DOSE COMBINATION OF NUTRACEUTICAL) Vs. LIFESTYLE MODIFICATION IN THE TREATMENT OF SPERM DNA FRAGMENTATION IN MARRIED ADULT MEN TO AID CONCEPTIO

Shield Heathcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•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 their partners 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.

•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.

发起方

Shield Heathcare Pvt Ltd