| 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
|
|
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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
|
|
|
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. |