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CTRI Number  CTRI/2024/11/077172 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Investigating the Role of Gut Health and Metabolic Factors in the Development of Polycystic Ovarian Syndrome Among Women in Gujarat 
Scientific Title of Study   A multicentric case-control study on the role of metabolic and microbiological factors in the development of polycystic ovarian syndrome among women of Gujarat 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Foram Ravat 
Designation  Research Scholar 
Affiliation  Gujarat Technological University School of Pharmacy  
Address  Gujarat Technological University School of Pharmacy, Gandhinagar Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate G.I.D.C, Sector 26, Gandhinagar,382028,Gujarat

Gandhinagar
GUJARAT
382028
India 
Phone  6354241715  
Fax    
Email  foramravat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kashyap Thummar 
Designation  Assistant Professor 
Affiliation  Gujarat Technological University School of Pharmacy  
Address  Gujarat Technological University School of Pharmacy, Gandhinagar Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate G.I.D.C, Sector 26, Gandhinagar,382028,Gujarat

Gandhinagar
GUJARAT
382028
India 
Phone  9427979959  
Fax    
Email  ap_kashyap@gtu.edu.in  
 
Details of Contact Person
Public Query  
Name  Ms Foram Ravat 
Designation  Research Scholar 
Affiliation  Gujarat Technological University School of Pharmacy  
Address  Gujarat Technological University School of Pharmacy, Gandhinagar Campus Nr. Government Polytechnic K6 Circle, E4 Electronic Estate G.I.D.C, Sector 26, Gandhinagar,382028,Gujarat

Gandhinagar
GUJARAT
382028
India 
Phone  6354241715  
Fax    
Email  foramravat@gmail.com  
 
Source of Monetary or Material Support  
Gujarat Technological University School of Pharmacy, Gandhinagar Campus Nr. Government Polytechnic K 6 Circle, E 4 Electronic Estate G.I.D.C, Sector 26, Gandhinagar, 382028, Gujarat 
 
Primary Sponsor  
Name  Gujarat Technological University School of Pharmacy 
Address  Gujarat Technological University School of Pharmacy, Gandhinagar Campus Nr. Government Polytechnic K 6 Circle, E 4 Electronic Estate G.I.D.C, Sector 26, Gandhinagar, 382028, Gujarat 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Foram Ravat PI   GMERS Medical Collage and Civil Hospital Ahmedabad  GMERS Medical College and Civil Hospital, Sola Ahmedabad
Ahmadabad
GUJARAT 		 6354241715

foramravat@gmail.com 
Ms Foram Ravat  Saavi Women’s Hospital, Prahladnagar, Ahmedabad  Saavi Women’s Hospital Vishal Tower Rd, opposite Shell Petrol Pump, near Ishan 3, Anand Nagar, Prahlad Nagar, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT 		 6354241715

foramravat@gmail.com 
Ms Foram Ravat  Shaswat IVF Women’s Hospital Ahmedabad  Shaswat IVF Women’s Hospital Nilkanth Palace B, 100 Feet Anand Nagar Rd, opp. Seema Hall, Satellite, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT 		 6354241715

foramravat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic committee, GMERS Medical Collage and Civil Hospital, Sola, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  As per inclusion and exclusion criteria. 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  The study involved PCOS-diagnosed and healthy controls from Gujarat clinics who will provide signed consent forms.

Females aged 18-40 (Both inclusion) who are confirmed with a PCOS, based on the Rotterdam criteria.

Women who are not pregnant or breastfeeding during the study period.

Women who have no acute, hormonal, or neoplastic conditions and autoimmune diseases.

Recruitment of healthy controls from hospitals, and educational institutions.

Note: We will recruit age, diet, & BMI matched control. The same exclusion criteria will apply for the control.
 
 
ExclusionCriteria 
Details  The study will exclude smokers, alcoholics, non-vegetarians, and tobacco-chewing participants.

This study will exclude participants who have used medications affecting insulin sensitivity (including those for blood pressure, steroids, cholesterol, hormonal contraceptives, antipsychotics, and antibiotics/prebiotics/probiotics) within the past 1 month.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The purpose of this research provides an understanding of the role of bile acid metabolite analysis and gut microbiota alteration between PCOS patients and control groups.  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment and understanding the association of homeostasis model assessment for Insulin Resistance (HOMA-IR) scores between lean-obese PCOS patients and the control groups.
 		 8 months 
Understand the association of gut microbiota species with bile acid levels (correlation analysis using statistic software).
 		 1 Year 
Based on the analysis, select potential pathogenic factors contributing to the development of PCOS.
 		 1 Year 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   09/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [foramravat@gmail.com].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary  

Background: 

Polycystic ovary syndrome (PCOS) is a highly prevalent infertility disorder characterized by endocrine, ovarian, and metabolic derangements. It is characterized by enlarged and dysfunctional ovaries, elevated androgen levels, insulin resistance, and other symptoms. According to a survey, 84% of Indian women reported having menstrual problems, and of them, 65% reported having irregular periods and expressing concerns about PCOS. The aetiology of PCOS remains enigmatic. Recently gut microbes have garnered attention as an essential player in this disorder, although the underlying mechanism remains scantly explored.

Novelty: 

Nascent evidence has suggested that the gut microbes-bile axis is the driver of pathogenesis of PCOS in Chinese women, presenting an exciting possibility of microbe-based therapies. However, gut microbes vary with regions; no study has yet examined the gut microbe-bile acid axis in PCOS women with insulin resistance in India, nor has any study identified keystone species that drive PCOS with insulin resistance in Indian women in a large cohort. 

Expected outcome:

The findings will characterise the gut microbiota-bile axis in PCOS with insulin resistance and help develop microbiome-based biomarkers and treatment of PCOS.

 
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