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CTRI Number  CTRI/2012/05/002656 [Registered on: 17/05/2012] Trial Registered Prospectively
Last Modified On: 25/02/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to see the effects and safety of two drugs IVF-Mâ„¢ (Menotropin)and Menopur® (Menotropin) in Infertile Women undergoing IVF treatment 
Scientific Title of Study   A multi-centre, open label, randomized, controlled parallel design phase IV study to compare and evaluate the clinical efficacy and safety of IVF-Mâ„¢ (Menotropin) versus Menopur® (Menotropin) in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IVFM-11-02, version 1.0 dated 01 Feb 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepali Mittal 
Designation  Deputy General Manager 
Affiliation  LG Life Sciences India Pvt Ltd 
Address  Plot no 11, sector 44, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  0124-4830000  
Fax  0124-4001148  
Email  deepali.mittal@lglsi.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Mittal 
Designation  Deputy General Manager 
Affiliation  LG Life Sciences India Pvt Ltd 
Address  Plot no 11, sector 44, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  0124-4830000  
Fax  0124-4001148  
Email  deepali.mittal@lglsi.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mita Nandy 
Designation  Senior Vice President 
Affiliation  LG Life Sciences India Pvt Ltd 
Address  Plot no 11, sector 44, Gurgaon

Gurgaon
HARYANA
122001
India 
Phone  0124-4830000  
Fax  0124-4001148  
Email  mita.nandy@lglsi.com  
 
Source of Monetary or Material Support  
LG Life Sciences India Pvt Ltd 
 
Primary Sponsor  
Name  LG Life Sciences India Pvt Ltd 
Address  Plot No 11, Sector 44, Gurgaon 122001 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vineet Mishra  Institue of Kidney Diseases & Research Centre, Institute of Transplantation Sciences (IKDRC-ITS)  Dept. of Obstetrics & Gynaecology, Civil Hospital Campus, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 
079-22685600

vvmivf@gmail.com 
Dr B N Chakravarty   Institute of Reproductive Medicine (IRM)  HB-36/A/3, Salt Lake City, Sector III, Kolkata 700 106
Kolkata
WEST BENGAL 
033-2321-5125
033-23215126
bncirm@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee, IRM, Kolkata  Approved 
The Internal Review Board, IKDRC, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Female infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Menopur® (Menotropin, Human Menopausal Gonadotropin 75 IU)  The initial starting dose is 150-225 IU/day.The dose is adjusted according to the ovarian response.Treatment is continued until adequate follicular development has been achieved. The maximum daily dose should not exceed 450 IU and dosing beyond 20 days is not recommended. Route of administration: intramuscular 
Intervention  Menotropin (Human Menopausal Gonadotropin 75 IU, 150 IU)  The initial starting dose is 150-225 IU/day.The dose is adjusted according to the ovarian response. Treatment is continued until adequate follicular development has been achieved. The maximum daily dose should not exceed 450 IU and dosing beyond 20 days is not recommended. Route of administration: intramuscular 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  Regular menstrual cycles of 24 to 35 days of duration, Normal basal FSH and LH during the early follicular phase, antral size follicles more than 5, Normal functional ovaries and uterus, Infertility due to any of the following factors: tubal factor, endometriosis (stage 1 or 2), male factor or unexplained factor, Willing to give voluntary written consent
 
 
ExclusionCriteria 
Details  1. Uterine myoma (fibroids)
2. Subjects with primary ovarian failure, uncontrollable hyperthyroidism or secondary adrenal insufficiency
3. Body Mass Index 30 kg/m2
4. Subjects with previous history of ovarian hyperstimulation syndrome (OHSS) in the previous IVF cycles
5. More than 3 previously consecutive unsuccessful IVF cycles
6. Any significant systemic disease, endocrine or metabolic abnormalities
7. Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland
8. Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD)
9. Intracranial bleeding
10. An organic intracranial lesion such as pituitary tumor
11. HIV or syphilis positive subjects
12. History of alcohol or drug addiction
13. Subjects smoking more than 5 cigarettes per day
14. History of hypersensitivity to hMG or other pharmaceutical excipients of this drug
15. Positive serum pregnancy test
16. Undiagnosed vaginal bleeding
17. Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures
18. Participation in any other clinical trial within 3 months of registering in this study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of oocytes retrieved  At the end of one in vitro fertilization cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Total administration dosage and duration of menotropin stimulation
Serum estradiol level on the day of hCG
Number of follicles 16mm on the day of hCG
Number of follicles more than or equal to 14mm on the day of hCG
Number of oocytes fertilized and fertilization rate
Number of embryos transferred
Embryo Implantation rate
Clinical pregnancy rate
Incidence rate of ovarian hyperstimulation syndrome
Adverse events
Laboratory test results
 
At the end of one IVF cycle 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/05/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a multi-centre, open label, randomized, parallel active controlled phase IV pilot study to compare and evaluate the clinical efficacy and safety of IVF-Mâ„¢ with Menopur® in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies. All patients’ treatment will be followed according to long gonadotropin-releasing hormone agonist protocol. 60 patients will be enrolled from two sites in India. Data will be analysed using appropraite statistical tests. 
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