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CTRI Number  CTRI/2024/04/065095 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Can Microfluidic sperm processing help improve pregnancy rates in IUI cycles  
Scientific Title of Study   Microfluidics for IUI to improve outcomes A comparative study in an Indian context 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Chaitanya Mantravadi 
Designation  Scientific Head 
Affiliation  Oasis Fertility 
Address  Oasis Fertility 8-2-269/3/1/4 Banjarahills Rd 2 - Hyderabad 34

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 8-2-269/3/1/4 Banjarahiils Rd 2 Hyderabad

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  Department of Embryology Oasis Fertility 3rd Floor Banjarahills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  08008812999  
Fax    
Email  krishna@oasisindia.in  
 
Source of Monetary or Material Support  
Oasis Fertility  
 
Primary Sponsor  
Name  Oasis Fertility  
Address  Banjarahills Hyderabad 
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 Jigna Tamagond  Oasis Fertility  Hyderabad
Hyderabad
TELANGANA 
08008812999

jigna.n@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  Infertility 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Normal Tubes and Uterus 
 
ExclusionCriteria 
Details  Severe Male Factor Cases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical pregnancy rates   6 weeks post ovulation 
 
Secondary Outcome  
Outcome  TimePoints 
Miscarriage   6-12 weeks post ovulation  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/04/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Intra uterine insemination is one of the most basic treatments offered to an infertile couple before any complex treatments like In-Vitro Fertilization (IVF)/ Intra-Cytoplasmic Sperm Injection (ICSI)

A number of factors determine the success of an IUI cycle, age of couple, duration of infertility, ovarian reserve and sperm parameters.

Total motile sperm count of the male partner is the most important prognostic factor determining the success of IUI treatment

The swim Up and density gradient method are frequently used to isolate the motile sperms from a raw sample of semen which can be inseminated into the uterus.

Although these methods help in isolating the motile sperms the clinical pregnancy rates with these methods is not more than 10-12 % and also there is a concern about the potential harmful effects on the natural properties of the sperm as these methods involve repeated centrifugation, and high-pressure forces being applied. Moreover, they are time consuming, and outcomes depend on the skill of the technician.

Micro fluidics is a cutting-edge technology which has proven benefits for sperm selection with greater DNA integrity in IVF/ICSI cycles simply because it is a much milder and efficient way to select the sperm based on its properties that of size and motility. The method takes a shorter time and is independent of the technician skills.

While there are multiple studies for Micro fluidics being used for IVF its benefit on IUI has not be 
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