| CTRI Number |
CTRI/2024/05/067866 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors affecting ease of embryo transfer procedure. |
|
Scientific Title of Study
|
Clinical and ultrasound parameters in predicting ease of embryo transfer: A
prospective cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S V Chaithanya |
| Designation |
MCh resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9632157251 |
| Fax |
|
| Email |
svchaithanya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidyashree G Poojari |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Reproductive Medicine and Surgery
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901731619 |
| Fax |
|
| Email |
vidyashree.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr S V CHAITHANYA |
| Designation |
MCh resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9632157251 |
| Fax |
|
| Email |
svchaithanya25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Manipal
576104
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 S V Chaithanya |
Kasturba Medical College Manipal pin code - 576104 |
Department of Reproductive Medicine and Surgery
Udupi
KARNATAKA |
9632157251
svchaithanya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethical COmmitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
all patients undergoing 1st embryo transfer |
|
| ExclusionCriteria |
| Details |
History of previous embryo transfer, history of hysteroscopic internal os resection,
Embryo Transfer (ET) under anesthesia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of predictive ability of each factor for ease of embryo transfer. Integration of clinical and ultrasound parameters to assess their combined predictive value for embryo transfer ease. |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biochemical pregnancy rate, clinical pregnancy rates. |
2 weeks & 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
04/06/2024 |
| 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) |
Open to Recruitment |
|
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
|
This a prospective observational study conducted in the department of Reproductive Medicine and Surgery, KMC Manipal. The study is regarding assessing clinical and ultrasound parameters that can predict the ease of embryo transfer procedure on their 1st attempt. the patients will be recruited after the informed consent. The grade of difficulty will be assessed. The results are analyzed after a study duration of 2 years. |