FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
Close