| CTRI Number |
CTRI/2025/11/097680 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Myo-inositol versus Metformin in women with PCOS who are keen on conceiving |
|
Scientific Title of Study
|
Effectiveness of Myo-inositol versus Metformin in women with PCOS who wish to conceive: A multicentre, randomized controlled trial
|
| Trial Acronym |
MYOMET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan S Kamath |
| Designation |
Senior professor and Head |
| Affiliation |
CMC, Vellore |
| Address |
Department of Reproductive Medicine and Surgery,
CMC, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283302 |
| Fax |
|
| Email |
mohankamath@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan S Kamath |
| Designation |
Senior professor and Head |
| Affiliation |
CMC, Vellore |
| Address |
Department of Reproductive Medicine and Surgery,
CMC, Vellore
TAMIL NADU
632004
India |
| Phone |
04162283302 |
| Fax |
|
| Email |
mohankamath@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan S Kamath |
| Designation |
Senior professor and Head |
| Affiliation |
CMC, Vellore |
| Address |
Department of Reproductive Medicine and Surgery,
CMC, Vellore
TAMIL NADU
632004
India |
| Phone |
04162283302 |
| Fax |
|
| Email |
mohankamath@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, PO Box No. 4911, Ansari Nagar, New Delhi - 110029, India. |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New
Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saubhagya Jena |
AIIMS Bhubaneswar |
Department of
Obstetrics and
Gynaecology AIIMS
Bhubaneshwar
Baleshwar 751019
Baleshwar
ORISSA |
9438884133
drsaubhagya@gmail.co m |
| Dr Himanshu Malakar |
AIIMS Guwahati |
Department of Obstetrics and Gynaecology
AIIMS Guwahati 781101
Kamrup
ASSAM |
9854609022
himangshumalakar@aiimsguwahati.ac.in |
| Dr Neena Malhotra |
AIIMS New Delhi |
Department Obstetrics and
Gynaecology, 3rd floor,
Teaching Block Near
Director Office AIIMS
Hospital
South
DELHI 110029
South
DELHI |
01126593361
malhotraneena@yahoo. com |
| Dr Sarita Rajbhar |
AIIMS Raipur |
Department of Obstetrics And Gynaecology
AIIMS Raipur 492099
Raipur
CHHATTISGARH |
8750978364
dr.sarita.rajbhar@gmail.com |
| Dr Girija Wagh |
Bharati Vidyapeeth Medical College Pune |
Department of Obstetrics and Gynaecology Bharati Vidyapeeth Medical College Pune 411043
Pune
MAHARASHTRA |
9422000584
girijawagh@gmail.com |
| Dr Mohan S Kamath |
Christian Medical College Vellore |
Department of Reproductive Medicine and Surgery
CMC Vellore 632004
Vellore
TAMIL NADU |
04162283302
dockamz@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| AIIMS BhubaneswarECR ethics committee |
Approved |
| AIIMS Delhi ethics committee |
Approved |
| AIIMS Guwahati |
Approved |
| AIIMS Raipur |
Approved |
| Bharati Vidyapeeth ethics committee |
Approved |
| Institutional Review Board CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metformin |
The first control arm will consist of Metformin therapy, 1500 mg daily, for three months, followed by OI with letrozole x 5 mg daily for up to 3 cycles along with Metformin for next 3 months |
| Intervention |
Myo-inositol |
Myo-inositol,4 grams daily, for three months followed by ovulation induction (OI) with letrozole x 5 mg daily for up to three cycles along with myo-inositol for next 3 months |
| Comparator Agent |
Placebo |
The second control arm will consist of an identical placebo for the initial three months, followed by OI with letrozole x 5 mg daily for up to 3 cycles with placebo for next 3 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
Women with PCOS, wishing to conceive and have
Body mass index more than or equal to 19 kg/m2 but less than or equal to 35 kg/m2
Duration of infertility less than or equal 6 years.
Willing to participate in the study and give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Couple not available for follow-up period (six months)
Pregnancy
Other androgen excess conditions such as late-onset CAH, androgen secreting tumours.
Diabetes mellitus
Pre -diabetic already on Metformin or another anti-diabetic
Untreated hypothyroidism (TSH more than 10 iu/ml) or hyper prolactinemia (more than 70 ng/ml)
On psychiatric medications or having chronic liver or renal disease in which the interventional or control drugs are relatively contraindicated
Previous history of receiving more than or equal to 12 ovulation induction cycles with Letrozole or Clomiphene or other ovulation induction treatment cycles with gonadotrophin or a combination of oral ovulogens and gonadotrophins
Other conditions of infertility that assisted reproduction such as severe male factor, advanced endometriosis, male partner with azoospermia, and documented severe tubal disease.
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Live birth rate per woman randomized |
Baseline to 16 months post-randomization for participants who conceive within six months post-randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical pregnancy rate |
Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization |
| Ongoing pregnancy rate |
Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization |
| Miscarriage rate |
Time frame: baseline to 12 months post-randomization for participants who conceive within 6 months after randomization |
| Ectopic pregnancy rate |
Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization |
| Stillbirth rate |
Time frame: baseline to 16 months post-randomization for participants who conceive within six months post-randomization |
| Time to pregnancy |
Time frame: baseline to 8 months post-randomization for participants who conceive within 6 months after randomization |
| Positive pregnancy rate |
Time frame: baseline to 7 months for participants who conceive within six months after randomization |
| Differences in anthropometric parameters |
Time frame: baseline to 6 months after randomization |
| Improvement in hormonal & metabolic parameters |
Time frame: baseline to 6 months post randomization |
| Pregnancy-related complications |
Time frame: baseline to 17 months post-randomization for participants who conceive within 6 months following randomization |
| Improvement in menstrual regularity |
Time frame: baseline to 6 months after randomization |
| Drug-related side effects |
Time frame: baseline to 8 months post randomization |
| Epigenetic changes |
Baseline & 6 months post intervention |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1305"
Sample Size from India="1305"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="5"
Months="0"
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - To gain access, the data requestors should approach the ICMR and individual ethics committee of the sites permission will be needed along with compliance with data sharing regulatory requirements as applicable
- For how long will this data be available start date provided 31-07-2030 and end date provided 01-07-2033?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The polycystic ovarian syndrome (PCOS) is a common gynaecological condition that affects women in the reproductive age group. Currently, between 15-20 million couples are affected in India, and PCOS is a common cause of infertility. Apart from infertility, PCOS is associated with long term complications such as cardiovascular diseases, diabetes mellitus as well as endometrial cancer. Commonly, apart from lifestyle intervention, Metformin therapy along with ovulation induction with Letrozole is considered as first-line pharmacological intervention. However, in contemporary practice, Myo inositol has also been used as an alternative to Metformin although the supportive evidence for Myo inositol is weak. Furthermore, there is scare data from the South Asian region. The current trial has been planned to study the effectiveness of Myo inositol in women with PCOS who wish to conceive and compare it against the Metformin as well as placebo. The main objective of the study is to assess whether fertility-related outcomes improve following Myoinositol compared to Metformin and placebo in women with PCOS who wish to concieve. The secondary objectives include assessing whether there is improvement in endocrinological & metabolic parameters as well as obstetrics outcomes following Myoinositol versus Metformin & placebo. Finally, we also want to asses if there are any epigenetic changes pre and post-intervention. The study is a multicentre placebo controlled randomized study involving women with PCOS who wish to conceive. The study results will inform us on whether use of Myoinositol is beneficial for women with PCOS who wish to conceive and fill in the knowledge gap in the area. It |