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CTRI Number  CTRI/2024/05/067505 [Registered on: 16/05/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational package on Intrauterine insemination ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The effectiveness of ‘Nurse-led educational package for intrauterine insemination’ on selected outcome variables among patients undergoing intrauterine insemination (IUI). 
Scientific Title of Study   A Randomised Controlled Trial to assess the effectiveness of ‘Nurse-led educational package for intrauterine insemination’ on selected outcome variables among patients undergoing intrauterine insemination (IUI) at Infertility Clinic, PGIMER, Chandigarh, 2023-25 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himanshu 
Designation  PG Student 
Affiliation   
Address  National Institute of Nursing Education, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9780272317  
Fax    
Email  stenzindolker92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhjit Kaur 
Designation  Tutor 
Affiliation  National Institute of Nursing Education PGIMER 
Address  Room 135, Obstetrics and Gynaecology, National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9914536469  
Fax    
Email  drsukhjitkaur13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sukhjit Kaur 
Designation  Tutor 
Affiliation  National Institute of Nursing Education PGIMER 
Address  Room 135, Obstetrics and Gynaecology, National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9914536469  
Fax    
Email  drsukhjitkaur13@gmail.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  Not Applicable  
Address  Not applicable  
Type of Sponsor  Other [Self funded] 
 
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 Sukhjit Kaur  Infertility Clinic  PGIMER
Chandigarh
CHANDIGARH 		 9914536469

drsukhjitkaur13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Package   The experimental group will receive an educational package regarding Intrauterine insemination 
Comparator Agent  Routine Care  The Comparator agent will receive the Routine care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  women undergoing intrauterine insemination at infertility clinic PGIMER 
 
ExclusionCriteria 
Details  Not Applicable 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
knowledge, Level of Stress, Level of Discomfort, quality of life  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Conception  3 months 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Many women visit Infertility Clinic from different states just to receive infertility treatment. Everyday 5-10 women receive Intrauterine Insemination treatment at Infertility clinic, PGIMER, Chandigarh. These women belong to different socioeconomic backgrounds. Their level of understanding about the treatment process also varies accordingly. In infertility clinic it was observed that the instructions about IUI process is given verbally. Non availability of an educational package at the Infertility clinic creates a lot of inconvenience to these women as well as to the health care professionals. Education related to intrauterine insemination including education regarding male and female reproductive system, infertility process, preparation for intrauterine insemination procedure which includes checklist for required articles and documents, relaxation technique and importance of follow up is important for better outcome and a successful conception. 

Null Hypothesis- There is no significant effect of the ‘Nurse-Led educational package for intrauterine insemination’ on selected outcome variables among participants undergoing intrauterine insemination.

 

Alternate Hypothesis- There is a significant improvement in selected outcome variables among participants undergoing intrauterine insemination after implementing ‘Nurse-Led educational package for intrauterine insemination’.

 
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