| CTRI Number |
CTRI/2024/12/077903 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link between problems getting pregnant and risk of heart disease in young women |
|
Scientific Title of Study
|
Association Between Infertility and Risk of Cardiovascular diseases in young Women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshani Ganjare |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, Ground floor, JNMC building Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7776040199 |
| Fax |
|
| Email |
roshaneeganjare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Vagga Mangalaram |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, Ground floor, JNMC building Sawangi
Datta Meghe Institute of Higher Education and Research. sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970001431 |
| Fax |
|
| Email |
anjalivagga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Vagga Mangalaram |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Biochemistry, Ground floor, JNMC building Sawangi
Datta Meghe Institute of Higher Education and Research. sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970001431 |
| Fax |
|
| Email |
anjalivagga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Roshani Ganjare |
Acharya Vinoba Bhave Rural Hospital |
Department of Biochemistry ground floor JNMC building
Wardha
MAHARASHTRA |
07776040199
roshaneeganjare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
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 |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. 78 gynecological and IVF patients, all of whom are aged above 25 years, encompassing both infertile and fertile women
|
|
| ExclusionCriteria |
| Details |
Women experiencing chromosomal abnormalities, genetic abnormalities, uterine abnormalities , hematological or immunological disorders, women with Diabetes, Hypertension Cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between cardiovascular illness and infertility in women in their middle years |
Assessment will be done at 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
01/01/2025 |
| 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="6"
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
|
Scientists and medical experts are beginning to understand the significant role that a woman’s past reproductive experiences play her potential risk of developing heart disease. Reproductive history is seldom considered when assessing the cardiovascular risk. Infertility, high blood pressure, and hypertension are risk factors for heart disease. Additional analyses were conducted to determine whether the apparent increase in risk could be influenced by other risk factors associated with infertility such as irregular menstruation, thyroid conditions, and waist circumference. This study aimed to investigate the association between cardiovascular risk and infertility in women and those who are fertile. The objectives of this study were to estimate the levels of serum creatinine kinase (MB) in both infertile and fertile control groups, as well as to estimate the LDL and HDL levels in the same groups. The study group comprised 78 participants, of which 39 were fertile and 39 were infertile. CK (MB), HDL, LDL, Uric acid, and high sensitivity C reactive Protein (hs-CRP) levels will be analyzed.
|