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CTRI Number  CTRI/2021/02/031447 [Registered on: 22/02/2021] Trial Registered Prospectively
Last Modified On: 22/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of scan findings to evaluate ovulation rate in patients undergoing ovulation induction treatment with Letrozole and Clomiphene citrate. 
Scientific Title of Study   Comparison of perifollicular and endometrial vascularity in patients undergoing ovulation induction with Clomiphene citrate and Letrozole 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nipasa Sarma 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  Dept of Obstetrics and gynaecology, KMC, Kasturba hospital, Manipal
Kasturba Medical College, Manipal, Udupi-576104, karnataka
Udupi
KARNATAKA
576104
India 
Phone  8810457450  
Fax    
Email  nipasasharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth K Adiga 
Designation  Professor 
Affiliation  Kasturba Hospital 
Address  Dept of Reproductive medicine and surgery (RMS), Kasturba hospital, Manipal, Karnataka
Dept of Reproductive medicine and surgery (RMS), Kasturba hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9035036832  
Fax    
Email  prashanth.adiga@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Nipasa Sarma 
Designation  Junior Resident 
Affiliation  Kasturba Hospital 
Address  Dept of Obstetrics and gynaecology, KMC, Kasturba hospital, Manipal
Dept of Obstetrics and gynaecology, KMC, Kasturba hospital, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8810457450  
Fax    
Email  nipasasharma@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Kasturba hospital, manipal 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Dept of Obstetrics and gynaecology, Kasturba hospital,KMC, Manipal, Udupi 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Prashanth K Adiga  Kasturba Hospital, Manipal  Room no-1, Dept of Reproductive medicine and surgery, Kasturba Hospital, Manipal
Udupi
KARNATAKA 
9035036832

prashanth.adiga@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital 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 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women undergoing Ovulation induction with Clomiphene citrate or Letrozole
 
 
ExclusionCriteria 
Details  1. Women undergoing any other form of infertility treatment.
2. Other causes of infertility will be excluded by documentation of a normal uterine cavity, atleast one patent fallopian tube and current partner having a normal semen analysis report 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
effect of clomiphene citrate and letrozole on perifollicular and endometrial vascularity  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Ovulation rate and pregnancy rate in patients treated with clomiphene citrate and letrozole  12 months 
 
Target Sample Size   Total Sample Size="190"
Sample Size from India="190" 
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)   22/02/2021 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Prospective observational study will be conducted in Kasturba Hospital, Manipal. Ethical clearance by Institutional Ethical Committee (IEC), Kasturba Hospital is taken. Women undergoing infertility treatment with ovulation induction will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure.
Cases will be divided into two groups based on treatment they are prescribed by their consultant. Group A (n= 95)will consist of patients who will receive treatment cycles with 50mg Clomiphene citrate from day 2 to day 6 of menstrual cycle. Group B (n= 95) will consist of patients who will receive treatment cycles with Letrozole 2.5mg from day 2 to day 6 of menstraul cycle. 
In both the groups endometrial and follicular vascularity will be assessed by transvaginal doppler ultrasound on the 11th day of menstrual cycle. The dominant or largest follicle, together with all follicles>18mm in diameter will be graded using power doppler. 
This grading system will be based on the percentage of perifollicular circumference that will depict an echo signal and will range from grades:
1. grade 0- no detectable blood flow
2. grade 1- visible blood flow in 1-25% of follicular circumference
3. grade 2- blood flow in 26-50% of follicular circumference 
4. grade 3- blood flow in 51-75% of follicullar circumference 
5. grade 4- blood flow in 76-100% of follicular circumference 
Endometrial vascularity will be graded as-
Type A- Homogenous pattern, defined as a single hyperechoic, hypoechoic or isoechoic layer with absent or poorly defined central echogenic line
Type B- Triple line pattern, defined as multi-layered endometrium consisting of a prominent outer and inner hyper-echoic line and inner hypoechoic regions
All data will be recorded in an Excel sheet.
Using Mann-Whitney U test, statistical analysis will be done to compare the perifollicular and endometrial vascularity between the two treatment groups. 
 
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