FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083033 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of metformin and myo-inositol with d-chiro-inositol on clinical, hormonal, and metabolic profile of infertile women with Polycystic Ovary Syndrome 
Scientific Title of Study   Comparative Study of Metformin Versus Myo-Inositol with D-chiro-Inositol on the Clinical, Hormonal and Metabolic Profiles in infertile women with PCOS: An Open-Label Randomized Trial 
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 Ann Sara Jacob 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER) 
Address  Obstetrics And Gynaecology Department, 2nd floor, Women and Child Hospital, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7025983552  
Fax    
Email  annsarajacob1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Chitra 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER) 
Address  Obstetrics And Gynaecology Department, 2nd floor, Women and Child Hospital, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9488818644  
Fax    
Email  drchitra@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ann Sara Jacob 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER) 
Address  Obstetrics And Gynaecology Department, 2nd floor, Women and Child Hospital, Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7025983552  
Fax    
Email  annsarajacob1997@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), JIPMER Campus road, Gorimedu, Dhanvantari Nagar, Puducherry, India, 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER) 
Address  Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), JIPMER Campus road, Gorimedu, Dhanvantari Nagar, Puducherry, India, 605006 
Type of Sponsor  Research institution and hospital 
 
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 Ann Sara Jacob  Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)  Infertility clinic, OPD Department of obstetrics and gynecology, Women and Child Hospital building, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry, INDIA, 605006
Pondicherry
PONDICHERRY 
7025983552

annsarajacob1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Interventional studies, JIPMER, Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N970||Female infertility associated withanovulation, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  metformin  The control group will be treated with metformin 500 mg BD for 3 months 
Intervention  myoinositol and d-chiro inositol  Study group will be treated with myoinositol and d-chiro inositol 2255 mg OD for 3 months 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  All infertile women with PCOS (Diagnosed according to Rotter-dam’s criteria) attending the infertility clinic/OPD at Women and Children Hospital, JIPMER:

1)Age of the Women: between 21 to 35 years
2) Women with PCOS according to Rotterdam 2003 criteria
3) Willing for regular follow-up
 
 
ExclusionCriteria 
Details  A woman who is a known case of
1) Thyroid disorders
2) Congenital adrenal hyperplasia
3) Adrenal tumors
4) Cushing syndrome
5) Presence of any chronic diseases eg; diabetes mellitus, Chronic kidney disease, liver disease, etc.
6) Women who are allergic to metformin or inositols
7) Patient on metformin therapy
8) Women on steroid therapy or Oral contraceptive pills usage for within three months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of metformin and myoinositol+ d-chiro inositol on meta-bolic parameter - HOMA IR in infertile women with PCOS.  from the day of entry to study and follow up visits at 4 weeks, 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To determine and compare the effects of Metformin and myoinositol with d-chiro inositol on
- Clinical parameters, Hormonal parameters, Metabolic parameters, USG parameters, Quality of life- PCOSQOL scale
 
from the day of entry to study and follow up visits at 4 weeks, 8 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   15/04/2025 
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="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 - NO
Brief Summary  

Polycystic Ovary Syndrome is a prevalent endocrine disorder affecting women of reproductive age, characterized by a combination of clinical, hormonal, and metabolic abnormalities, including hyperandrogenism, ovulatory dysfunction, and insulin resistance.

 Metformin, an insulin-sensitizing drug has been shown to improve insulin resistance, reduce androgen levels, and promote ovulation in women with PCOS. Despite its efficacy, metformin is associated with gastrointestinal side effects, leading to the exploration of alternative therapies

Myo-inositol and D-chiro-inositol, naturally occurring compounds involved in insulin signaling, have emerged as promising alternatives to metformin. These inositols, particularly when used in combination, are thought to improve insulin sensitivity, restore hormonal balance, and regulate menstrual cycles in women with PCOS . Several studies suggest that the combination of MI and DCI can positively influence the metabolic and reproductive profiles of PCOS patients, with fewer side effects compared to pharmacological treatments like metformin.

However, direct comparisons between metformin and the MI/DCI combination are limited. Most of the studies are not randomized with few sample size or having heterogeneous population. This study aims to fill this gap by comparing the effects of metformin and MI/DCI on the clinical, hormonal, and metabolic profiles of women with PCOS, providing crucial data to guide more effective and tolerable treatment options.

In infertility clinic and OPD, after diagnosis of PCOS and informed consent baseline investigations like clinical, metabolic and hormonal parameters are done along with baseline TVS scan and PCOSQOL scale. Patients will be randomized to either the interventional group or the control group . Study group will be treated with myoinositol and d-chiro inositol 2255 mg OD for 3 months. The control group will be treated with metformin 500 mg BD for 3 months. Subjects will be called for follow up  visits at 4 weeks, 8 weeks and 12 weeks. At Every follow up visit, counselling sessions, adherence and side effects are noted.  After the last visit  all parameters- clinical, metabolic and hormonal will be checked and quality of life using PCOSQOL scale will be assessed. 


 
Close