Health Condition 1: N469- Male infertility, unspecified
Conditions
Interventions
Intervention1: Dfrag Tablet: Dfrag Tablets 1 BD for 3 months
plus lifestyle modification and
medical counselling
Control Intervention1: Lifestyle modification and
medical counselling: Lifestyle modifi
Sponsors
Shield Heathcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment.Timepoint: Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3. Detection of pregnancy in female partners by urine pregnancy test or positive serum beta HCGTimepoint: Baseline and 3 month Pregnancy tests Baseline and 9 months | — |
Countries
India
Contacts
Public ContactDr Prachi Ahire
Shield Healthcare Pvt. Ltd
Outcome results
None listed