| CTRI Number |
CTRI/2024/09/074235 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how blood flow in the uterus affects pregnancy success in embryo transfer patients. |
|
Scientific Title of Study
|
Study of uterine artery blood flow parameters in embryo transfer patients and its reproductive outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Nivedita Sivadas |
| Designation |
MCh Resident |
| Affiliation |
Kasturba Medical college Manipal, MAHE, Manipal |
| Address |
Department of reproductive medicine and surgery,
Kasturba Medical college,Manipal,
Manipal Academy of Higher Education.
Udupi
KARNATAKA
576104
India |
| Phone |
9495947280 |
| Fax |
|
| Email |
sreenivedita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth K Adiga |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical college and Hospital, Manipal |
| Address |
Professor and Head
Department of Reproductive Medicine and Surgery ,
Kasturba Medical college and Hospital ,Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9035036832 |
| Fax |
|
| Email |
prashanth.adiga@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth K Adiga |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical college and Hospital, Manipal |
| Address |
Professor and Head
Department of Reproductive Medicine and Surgery ,
Kasturba Medical college and Hospital ,Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9035036832 |
| Fax |
|
| Email |
prashanth.adiga@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college and Hospital, Manipal Academy of Higher Education, Manipal,Udupi,576104
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
V Nivedita Sivadas |
| Address |
Mch Resident
Department of reproductive medicine and surgery, Kasturba Medical college and Hospital, MAHE,Manipal, Udupi 576104,
Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Prashanth Adiga |
Kasturba Medical college and Hospital, Manipal. |
Scan room, Department of Reproductive Medicine and Surgery, Manipal Assisted Reproduction Centre (MARC)
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: N971||Female infertility of tubal origin, (2) ICD-10 Condition: N970||Female infertility associated withanovulation, (3) ICD-10 Condition: N972||Female infertility of uterine origin, (4) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
transvaginal ultrasound colour doppler scan. |
transvaginal ultrasound colour doppler scanning is done on the IVF patients. on the day of ovulation trigger in fresh embryo transfer patients and on the day of progesterone gel initiation in frozen embryo transfer patients. Uterine artery pulsatality index,resistance index, peaksystolic velocity, endometrial thickness, endometrial vascularity will be measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18-40
Patients willing to give consent
Fresh embryo transfer
Frozen embryo transfer
Mild male factor infertility
Tubal factor infertility
Unexplained infertility |
|
| ExclusionCriteria |
| Details |
Uterine malformation
Cavity distorting fibroid uterus
Intra Uterine adhesions
Tuberculosis
Grade 3 embryo transfer
PGT couples
Adenomyosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uterine artery pulsatality index,Uterine artery resistance index,
Peak systolic velocity of uterine artery |
Baseline,2 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Serum beta hcg
Clinical pregnancy rate. |
14 days after recruitment.
4 weeks after recruitment. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/12/2024 |
| 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="2"
Months="0"
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
|
Data will be collected from patients who are willing to give consent. Baseline characteristics will age, BMI, type of infertility, obstetrics history, cause of infertility. known comorbidities. embryo transfer protocols. blood hormone values which are routinely done during the course of treatment will be noted. Transvaginal ultrasound colour doppler of uterine artery will be measured on the day of ovulation trigger for fresh embryo transfer patients. For frozen embryo transfer patients same will be measured on the day of progesterone gel initiation. The measurements are taken along with the routine ultrasound scan which is done for patients during this time. Pulsatality index , resistance index, peak systolic velocities of both uterine arteries and its mean will be measured. Endometrial thickness , endomterial vascularity, number of embryos transferred , grade of embryos will be noted. As standard procedure , patients will be called after 14 days of embryo transfer to measure serum beta hcg values . clinical pregnancy is determined by the presence of gestational sac on ultrasound for positive beta hcg patients at 6 weeks of gestation.This will also be noted. |