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CTRI Number  CTRI/2024/08/072284 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 03/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Screening 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Treatment for Raised sperm DNA Fragmentation  
Scientific Title of Study   EFFECT OF DIFFERENT INTERVENTIONS USED FOR RAISED SPERM DNA FRAGMENTATION INDEX AND THEIR IMPACT ON REPRODUCTIVE OUTCOMES  
Trial Acronym  SDF 
Secondary IDs if Any  
Secondary ID  Identifier 
ECR/1312/INST/TG2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Chaitanya Mantravadi 
Designation  Scientific Head 
Affiliation  Oasis Fertility 
Address  Oasis Fertility Department of Clinical Embryology 3rd floor Banjarahills Rd no. 2 Next to NATCO building Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  krishna@oasisindia.in  
 
Details of Contact Person
Scientific Query
 
Name  Krishna Chaitanya Mantravadi 
Designation  Scientific Head 
Affiliation  Oasis Fertility 
Address  Oasis Fertility Department of Clinical Embryology 3rd floor Banjarahills Rd no. 2 Next to NATCO building

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  krishna@oasisindia.in  
 
Details of Contact Person
Public Query
 
Name  Krishna Chaitanya Mantravadi 
Designation  Scientific Head 
Affiliation  Oasis Fertility 
Address  Oasis Fertility Department of Clinical Embryology 3rd Floor Banjarahills Rd no. 2 Next To NATCO building

Hyderabad
TELANGANA
500034
India 
Phone  8008812999  
Fax    
Email  krishna@oasisindia.in  
 
Source of Monetary or Material Support  
NO funding 
 
Primary Sponsor  
Name  Oasis Fertility  
Address  8-2-269/3/1/4 SAI NILAYAM 3rd Floor Room number 101, NEAR NATCO PHARMA BUILDING BANJARAHIILS RD 2 HYDERABAD- 500034 
Type of Sponsor  Private hospital/clinic 
 
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 Krishna Chaitanya  Oasis Fertility  Department of Embryology 3rd Floor Room number 101 Next to NATCO building Banjarahills Road No 2 - 500034
Hyderabad
TELANGANA 
7337330437

krishna@oasisindia.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Oasis Fertility   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young male infertility subjects are recruited 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DAILY OR FREQUENT EJACULATION   Subjects would be advised to ejaculate daily for 5-7 days and then a fresh ejaculate of semen is taken for IVF process  
Intervention  MAGNETIC ACTIVATED SPERM CELL SORTING (MACS)  In this intervention semen sample is produced by masturbation and using MACS technique, sperms with good DNA quality are filtered and used for IVF 
Intervention  MICROFLUIDICS SPERM SORTING  In this intervention semen sample is produced by masturbation and using microfluidics chip technique, sperms with good DNA quality are filtered and used for IVF 
Intervention  TESTICULAR SPERM ASPIRATION (TESA)  Patient Is Subjected To Short General Anaesthesia And Testes Is Subjected To Surgical Retrieval Of Sperms Through Fine Needle Aspiration. This Is A Minimally Invasive Surgery And A Day Care Procedure With No Recruitment For Hospitalisation.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Raised sperm DNA fragmentation index beyond 30% 
 
ExclusionCriteria 
Details  VARICOCOELE
ALCOHOL
SMOKING
HIGH BMI 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in sperm DNA Fragmentation   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
implantation rates and live birth rates   4 weeks after embryo transfer procedure and 9months after positive pregnancy test  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) 08/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

There are many couples who fail to conceive despite the absence of any apparent reasons, which remain undiscovered during complete infertility investigation or even after necessary treatment intervention. Such a condition may be termed as unexplained infertility. Criteria may include normal history and physical examination, adequate and appropriate coital frequency, three normal semen analysis, regular monthly cycles with a luteal phase of 12 days, adequate cervical mucus and normal post-coital test, normal hormone assay and tubal patency (hysterosalphingogram). The reported overall prevalence of unexplained infertility ranges from 6% to 27%. Male factors contribute significantly to unexplained infertility.

 

Male infertility of unknown origin is a condition in which fertility impairment occurs spontaneously or due to an obscure or unknown cause. It includes two categories, unexplained male infertility and idiopathic male infertility. The dividing line between them is semen analysis, which is normal in the unexplained category and abnormal in idiopathic infertility.

 

During the past couple of decades, several new methods for the assessment of human sperm function have been introduced. These relatively newer technologies have helped detect several defects at various stages of sequential events taking place in human fertilization in patients with otherwise unexplained infertility (UNFPA, 2002). After ruling out female infertility factors, erectile problems and coital factors, modern andrology may help to analyze the unexplained male fertility problem on the basis of cellular and sub cellular mechanisms. Furthermore, this analysis may lead to the selection of proper treatment options fitting the needs of patients with unexplained infertility (Agarwal et al., 2011) and failed IVF attempts.

 
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