| CTRI Number |
CTRI/2024/09/074375 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Diversity in Polycystic Ovarian Syndrome: A Comprehensive Study of Symptoms, Hormones, Body Composition, and Autonomic Nervous System Activity |
|
Scientific Title of Study
|
Mapping Heterogeneity in Polycystic Ovarian Syndrome: Integrating Clinical, Endocrinological, Body Composition Analysis and Vagosympathetic Tone - A Prospective Case Control 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 Medhavi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Rajkot |
| Address |
Hospital Bulding, First Floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Rajkot GUJARAT 360010 India |
| Phone |
8302268405 |
| Fax |
|
| Email |
dr.medhavisharma23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Medhavi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Hospital Building, First Floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Rajkot GUJARAT 360010 India |
| Phone |
8302268405 |
| Fax |
|
| Email |
dr.medhavisharma23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Medhavi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Hospital Building, First Floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Para Pipaliya, Rajkot
Rajkot GUJARAT 360010 India |
| Phone |
8302268405 |
| Fax |
|
| Email |
dr.medhavisharma23@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Para Pipaliya, Rajkot 360010 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rajkot |
| Address |
All India Institute of Medical Sciences, Para Pipaliya, Rajkot. 360010 |
| Type of Sponsor |
Government 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 |
| Dr Medhavi Sharma |
All India Institute of Medical Sciences, Rajkot |
Hospital Building, First Floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rajkot, Para Pipaliya, Rajkot 360010 Rajkot GUJARAT |
8302268405
dr.medhavisharma23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, All India Institute of Medical Sciences, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HRV in Non-PCOS patients and its correlation with Hormonal Profile. |
HRV in Non-PCOS patients and its correlation with Hormonal levels of Hormonal levels of Serum Insulin, Serum testosterone, Fasting Blood Sugar, AMH, DHEA, FSH, LH, and 17-OH progesterone only once during the study. |
| Intervention |
HRV in PCOS patients and its correlation with clinical sub-types of PCOS and Hormonal profile. |
HRV in PCOS patients and its correlation with clinical subtypes of PCOS and Hormonal levels of Serum Insulin, Serum testosterone, Fasting Blood Sugar, AMH, DHEA, FSH, LH, and 17-OH progesterone only once during the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The control group will be recruited from following inclusion criteria:
a. Women between age 18–45 years
b. Normo-androgenic Women (Absence of hirsutism)
c. With history of regular, ovulatory menstrual cycles
d. Morphologically normal ovaries on ultrasound. (The diagnosis of PCOS will be based on 2003 Rotterdam ESHRE/ASRM PCOS Consensus Workshop Group diagnostic criteria.)
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria includes:
a. Hyperandrogenism (Cushing’s syndrome (based on history taking and physical examination, Late-onset congenital adrenal hyperplasia (by estimating the serum levels of 17-hydroxyprogesterone).
b. Pregnant and breastfeeding women
c. Patient on medications (Medications for Diabetes, Hypo/Hyperthyroidism, Dyslipidaemia, Hyperprolactinemia)
d. Chronic or acute pelvic infection (Within the previous 30 days), any other serious medical problem
e. Hormonal contraception and/or Anti-androgen therapy (Within the previous 6 months)
f. Patients not willing or able to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vagosympathetic balance and HRV parameters in PCOS and Non PCOS patients. |
HRV will be done after confirmation PCOS by clinical examinations and Hormonal Profile, only once during the study after recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Corelation between different sub-types of PCOS with HRV & hormonal profiles |
At Baseline. |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
04/10/2024 |
| 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="1" 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
|
Polycystic Ovary Syndrome (PCOS) is a multifaceted endocrine disorder affecting millions of individuals worldwide, characterized by its clinical heterogeneity.[1] Current diagnostic modality, Rotterdam Criteria, primarily relies upon clinical symptoms, hormonal imbalances (hyperandrogenism), and ultrasound findings.[2] However, this criterion often falls short in capturing the full spectrum of PCOS manifestations in various phenotypic subgroups. Recognizing the need for a more precise phenotypic classification system, there is a growing consensus that such a system is essential for gaining a deeper understanding of the condition, predicting its clinical trajectory, and tailoring interventions more effectively. While previous research has separately delved into PCOS from hormonal and metabolic perspectives, there has been a conspicuous absence of a comprehensive exploration into the connections between PCOS phenotypes, body composition, hormonal profiles, and vagosympathetic balance. This study seeks to bridge this critical knowledge gap by simultaneously employing advanced body composition analysis techniques [3-6], incorporating recent endocrine biomarkers like Anti-Müllerian Hormone (AMH) [7], and assessing vagosympathetic balance [5] to reclassify individuals with PCOS. The outcomes of this research will illuminate the heterogeneity of PCOS [8-10] and contribute to the development of more personalized diagnostic and therapeutic strategies, ultimately leading to improved patient outcomes. |