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CTRI Number  CTRI/2021/12/038935 [Registered on: 27/12/2021] Trial Registered Prospectively
Last Modified On: 24/12/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the use of Dfrag nutritional supplement with lifestyle modification in males with infertility. 
Scientific Title of Study   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 CONCEPTION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Durga G Rao 
Designation  Medical Director, Oasis Fertility 
Affiliation  Oasis Fertility 
Address  #8-2-269/3/1/4, Near NATCO Pharma, Banjara Hills Road No. 2, Hyderabad 500034, Telangana, India

Hyderabad
TELANGANA
500034
India 
Phone  9490624638  
Fax  040-40185150  
Email  durga@oasisindia.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prachi Ahire 
Designation  Head Medical Affairs 
Affiliation  Shield Healthcare Pvt. Ltd 
Address  Shield Healthcare Pvt. Ltd. No. M49 & M50, 2nd Floor, Classic Royal, LB Rd, Chennai – 600020, Tamil Nadu, India

Chennai
TAMIL NADU
600020
India 
Phone  09930258855  
Fax    
Email  drprachi.ahire@shieldhealthcare.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Prachi Ahire 
Designation  Head Medical Affairs 
Affiliation  Shield Healthcare Pvt. Ltd 
Address  Shield Healthcare Pvt. Ltd. No. M49 & M50, 2nd Floor, Classic Royal, LB Rd, Chennai – 600020, Tamil Nadu, India
Shield Healthcare Pvt. Ltd. No. M49 & M50, 2nd Floor, Classic Royal, LB Rd, Chennai – 600020, Tamil Nadu, India
Hyderabad
TAMIL NADU
600020
India 
Phone  09930258855  
Fax    
Email  drprachi.ahire@shieldhealthcare.co.in  
 
Source of Monetary or Material Support  
Shield Healthcare Pvt Ltd 
 
Primary Sponsor  
Name  Shield Heathcare Pvt Ltd 
Address  Shield Healthcare Pvt. Ltd. No. M49 and M50, 2nd Floor, Classic Royal, LB Rd, Chennai – 600020, Tamil Nadu, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Durga G Rao  Oasis Fertility  1st floor, Sai Nilayam building, Dr Durga Rao chamber, #8-2-269/3/1/4, Near NATCO Pharma, Banjara Hills Road No. 2, Hyderabad 500034, Telangana, India
Hyderabad
TELANGANA 		 9490624638

durga@oasisindia.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oasis Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N469||Male infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dfrag Tablet  Dfrag Tablets 1 BD for 3 months plus lifestyle modification and medical counselling 
Comparator Agent  Lifestyle modification and medical counselling  Lifestyle modification and medical counselling 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment.  Mean change in sperm DNA fragmentation index between baseline and 3 months post treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
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 HCG 		 Baseline and 3 month
Pregnancy tests Baseline and 9 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be done after completion of study 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  Ethics committee

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  through publication

  6. For how long will this data be available start date provided 30-12-2022 and end date provided 30-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
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.
 
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