| CTRI Number |
CTRI/2019/12/022258 [Registered on: 05/12/2019] Trial Registered Retrospectively |
| Last Modified On: |
05/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of two different regimens for treatment of infertility in infertile PCOS women |
|
Scientific Title of Study
|
TO compare two drug combinations to improve pregnancy rate in infertile women with PCOS |
| Trial Acronym |
To compare the effect of Metformin plus Myoinositol versus Myoinositol alone in terms of clinical pregnancy rate in infertile PCOS women |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Prabhakar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
E-96,Sudarshan Cinema Road,Gautam Nagar,Delhi
New Delhi
DELHI
110049
India |
| Phone |
7903306116 |
| Fax |
|
| Email |
priyankaprabhakar009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reeta Mahey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
A-21,Second Floor,South extension Part-2,Delhi
New Delhi
DELHI
110049
India |
| Phone |
9818447845 |
| Fax |
|
| Email |
reetamahey52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reeta Mahey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
A-21,Second Floor,South extension Part-2,Delhi
New Delhi
DELHI
110049
India |
| Phone |
9818447845 |
| Fax |
|
| Email |
reetamahey52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akumentis healthcare Ltd
504,5th floor,G-Corp Tech Park,Near Hypercity,Kasarvadavalli,Ghodbandar Road,Owale,Thane,Maharashtra.
Pin-400615 |
| Eris Lifesciences Ltd.
7th floor,Commerce House IV,100 feet Road,Prahlad Nagar,Ahmedabad,Gujarat
Pin-380015 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences,Ansari Nagar East,Pincode-110029 |
| 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 Priyanka Prabhakar |
Outpatient Department,Department of Obstetrics and Gynecology,AIIMS |
Room no 3,3rd Floor,Rajkumari OPD,Department of Obstetrics & Gynecology,AIIMS,New Delhi
New Delhi
DELHI |
7903306116
priyankaprabhakar009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin and Myo-inositol |
Tab Metformin 500mg three times a day and Tab Myoinositol 2g per day for 6 months |
| Comparator Agent |
Myoinositol |
Tab Myoinositol 2g twice a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
1. Infertile women with PCOS(according to Rotterdam criteria)
2.Women 20-38 years of age
3.BMI<30 kg/m2
4. Willing to participate in study and follow up.
5.Bilateral patent tubes on hysterosalpingography/laparoscopy. |
|
| ExclusionCriteria |
| Details |
1.Patients already on other drugs for treatment of PCOS like OCPs.
2.Deranged kidney or liver function tests
3.Uncontrolled Thyroid disorders/impaired GTT/Diabetes mellitus.
4.Known hypersensitivity to Myoinositol or Metformin.
5.Moderate to severe male factor infertility.
6.Women with ny other endocrinological disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total number of women attaining clinical pregnancy in either group(confirmed by USG) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in clinical,metabolic and hormonal parameters in PCOS women.
|
3 months |
Ovulation rate.
|
3 months |
Ongoing pregnancy rate(POG12 wks)
|
6 months |
Total number of OHSS cases.
|
6 months |
Total number of abortions occurring in present pregnancy.
|
6 months |
| Total number of ectopic or multiple pregnancies. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Insulin resistance is one of the main component of polycystic ovary syndrome. Metformin is an insulin sensitiser being used along with ovulation induction to improve pregnancy rate in infertile PCOS women. But main disadvantage of Metfomrin is gastro-intestinal side effects. Inositol have been recently studied in infertile PCOS women and have been seen to improve insulin resistance. Both Metformin and Myoinositol improve insulin resistance but through different mechanisms. The present study is being conducted to evaluate whether combination of Metformin and Myo-inositol will have better effect in terms of clinical pregnancy rate as compare to Myoinositol alone in infertile PCOS women. In initial 3 months of study, only the drugs will be given and couples will be advised to try for natural conception. After 3 months, patients who will not conceive, will be given Letrozole with or without gonadotrophin for ovulation induction for 3 cycles. Main primary outcome will be clinical pregnancy rate. |