| CTRI Number |
CTRI/2018/03/012452 [Registered on: 09/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
role of ultrasound doppler in ovulation induction cycles |
|
Scientific Title of Study
|
Assessment of endometrial receptivity using Doppler ultrasonography in infertile women in controlled ovarian stimulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana Narula Wadhwa |
| Designation |
Senior Research Associate |
| Affiliation |
ESIC PGIMSR BASAI DARAPUR |
| Address |
ESIC PGIMSR BASAI DARAPUR DELHI 110015
New Delhi
DELHI
110015
India |
| Phone |
9873690297 |
| Fax |
09873690297 |
| Email |
dr.sanjana297@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Wadhwa |
| Designation |
proffesor |
| Affiliation |
ESIC PGIMSR BASAI DARAPUR |
| Address |
ESIC PGIMSR BASAI DARAPUR DELHI 110015
New Delhi
DELHI
110015
India |
| Phone |
9910933447 |
| Fax |
09910933447 |
| Email |
dr_leena123@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjana Narula Wadhwa |
| Designation |
Senior research associate |
| Affiliation |
ESIC PGIMSR BASAI DARAPUR |
| Address |
ESIC PGIMSR BASAI DARAPUR DELHI 110015
New Delhi
DELHI
110015
India |
| Phone |
9873690297 |
| Fax |
09873690297 |
| Email |
dr.sanjana297@gamil.com |
|
|
Source of Monetary or Material Support
|
| ESIC PGIMSR Basaidarapur Delhi |
|
|
Primary Sponsor
|
| Name |
Council of scientific and industrial research ministry of science technology Government of India |
| Address |
Government office library avenue Pusa Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Sanjana Narula Wadhwa |
ESIC PGIMSR |
Basaidarapur Delhi 110015
New Delhi
DELHI |
9873690297
9873690297
dr.sanjana297@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee ESIC PGIMSR hospital complex basaidarapur delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
There is no interventional agent as this is an observational study
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
All cases planned for controlled ovarian stimulation cycles.
Age 20-38 yrs
Primary or secondary infertility
|
|
| ExclusionCriteria |
| Details |
Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions, Asherman’s syndrome, bicornuate uterus, septate uterus)
Women with acute vaginal and cervical infection
Endometriosis and hydrosalpinx
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical pregnancy rate
|
1year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Miscarriages, ectopic pregnancy
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
12/03/2018 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aim: •To evaluate endometrial and subendometrial blood flow parameters in controlled ovarian stimulation cycles at the time of hCG trigger. • To evaluate follicular vascularity in controlled ovarian stimulation cycles. •To assess the relationship between endometrial, subendometrial,perifollicular blood flows and pregnancy outcome. Material and method: Prospective observational clinical study. Infertility Cases planned for controlled ovulation stimulation (COS) will be enrolled. They will be divided into 3 groups depending upon the protocol: •Group 1- clomiphene citrate (CC) •Group 2 - CC +HMG •Group 3 -recombinant FSH /Gonadotrophin cycle Ultrasound measurement of all patients will be performed from day 7 onwards. Ultrasound will be performed by investigator, on the day of hCG injection, once there is DF 20-22 mm with Clomiphene & 18 mm with gonadotrophins. •The endometrial pattern & thickness will be noted. •Endometrial & perifollicular blood flow will be studied. •The findings will be correlated with pregnancy outcomes. Endometrial thickness on the day of HCG injection (mm)
Morphology of endometrium : Type A Type B Type C
Uterine blood flow S/D PI RI
Endometrial blood flow Zone1: subendometrial, Zone2: midzone of endometrium. Zone 3: towards cavity Group A-no endometrial blood flow Group B-sudendometrial blood flow present Group C -endometrial and subendometrial blood flow present Perifollicular blood flows: F1 <25%, F2 -26%-50%, F3- 50%- 75%, F4 >75%
Categorical variables will be presented in number and percentage (%) and continuous variables will be presented as mean ± SD and median. Qualitative variables will be correlated using Chi-Square test /Fisher’s exact test. A p value of <0.05 will be considered statistically significant. The data will be entered in MS EXCEL spreadsheet and analysis will be done using Statistical Package for Social Sciences (SPSS) version 21.0. Outcome: •Primary: Clinical pregnancy rate •Secondary:Miscarriages, ectopic pregnancy
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