| 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
|
|
|
Primary Sponsor
|
| Name |
Oasis Fertility |
| Address |
Banjarahills Hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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 |