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
|
|
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
|
|
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. |