| CTRI Number |
CTRI/2024/06/069159 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Ovarian endometrioma on blood flow in uterine and ovarian arteries and oocyte quality
|
|
Scientific Title of Study
|
Comparison of Uterine and Ovarian artery doppler indices and Oocyte characteristics in women with and without Ovarian endometrioma |
| 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 Shivangi Tiwari |
| Designation |
Mch Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, MARC, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8439352615 |
| Fax |
|
| Email |
shivangi131995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Suneel Mundkur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686448802 |
| Fax |
|
| Email |
anjali.suneel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Suneel Mundkur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Reproductive Medicine and Surgery, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686448802 |
| Fax |
|
| Email |
anjali.suneel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal 576104 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 Shivangi Tiwari |
Kasturba Medical College, Manipal |
Department of Reproductive Medicine and Surgery, Manipal Assisted Reproduction Centre, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
8439352615
shivangi131995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N801||Endometriosis of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Body mass index
Primary and Secondary infertility
Regular menstrual cycle
Normal uterine cavity screened by Transvaginal USG or hysteroscopy
|
|
| ExclusionCriteria |
| Details |
1. Current hormonal treatment
2. Coexistence of other adnexal masses (teratoma, tubo-ovarian abscess)
3. Previous pelvic surgery
4. Smokers
5. Any pelvic pathology, including uterine fibroids, ovarian cysts (other than
endometriomas) and hydrosalpinx
6. General disease or on any medication that could affect pelvic blood flow
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uterine and ovarian artery Doppler indices, oocyte characteristics in women with and without ovarian endometrioma |
Uterine and Ovarian artery doppler indices at baseline
Oocyte characteristics on the day of oocyte pickup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of changes in the ovarian & uterine artery Doppler indices before & after endometrioma surgery
Correlation of endometrioma size with oocyte characteristics |
Ovarian & Uterine artery Doppler indices at baseline & one month after surgery.
Oocyte characteristics on the day of oocyte pickup correlated with size of endometrioma at baseline scan |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2024 |
| 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
|
There are only a few studies investigating the colour Doppler parameters in ovarian endometrioma including post-surgery and evaluating oocyte characteristics. In addition, the correlation of endometrioma size with oocyte characteristics is seen in this study. Theoretically, endometrioma may affect blood flow patterns, so this issue might be a standing point for developing new therapeutic and preventative modalities for endometriosis.
|