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CTRI Number  CTRI/2013/06/003749 [Registered on: 13/06/2013] Trial Registered Prospectively
Last Modified On: 29/12/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to see the effects, safety and patient compliance of two drugs Newmon-Râ„¢ pre filled syringe and Gonal-F® pen 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, safety and patient compliance of Newmon-Râ„¢ (rhFSH) Pre-filled Syringe versus Gonal-F® Pen in Infertile Women undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NR-11-01, 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 VP 
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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudip Basu  AMRI Medical Centre  Obstetric and Gynaecology division, 97 A, Southern Avenue, Kolkata-29
Kolkata
WEST BENGAL 		 033-66228000

sbasu64@gmail.com 
Dr B N Chakravarty  Institute of Reproductive Medicine  HB-36/A/3, Salt Lake City, Sector III, Kolkata 700 106
Kolkata
WEST BENGAL 		 033-23215125

bncirm@gmail.com 
Dr Nayana Patel  Kaival Hospital  Naya Padkar Lane, Station Road, Anand – 388001, Gujarat
Anand
GUJARAT 		 02692-253789

nayana@ivfsurrogate.com 
Dr Purnima Nadkarni  Nadkarni Hospital & Test Tube Baby Centre  Char Raasta, N. H. No. 8, Killa Pardi-396125, Dist –Valsad, Gujarat.
Valsad
GUJARAT 		 0260-2373269

nadkarnihospital@gmail.com 
Dr Pooja Nadkarni Singh  Nadkarni’s 21st Century Hospitals & Test Tube Baby Centre  51/B, Dawer Plaza, Sufi Baug, Station Road, Surat – 395003, Gujarat.
Surat
GUJARAT 		 0261-2490190

poojanadkarni@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Fertility Foundation Ethical Committee, Kolkata, Dr. Sudip Basu  Approved 
Institute Ethics Committee, Institue of Reproductive Medicine, Kolkata  Approved 
SKHPL Ethics Committee, Sat Kaival Hospital Pvt Ltd, Anand, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Female infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gonal-F® Pen   The initial starting dose is 150-225 IU/day commencing on mense day 2. The dose is adjusted according to the ovarian response. Treatment is continued until adequate follicular development has been achieved.Maximum daily dose should not exceed 450 IU. Route of administration: subcutaneous 
Intervention  Newmon-Râ„¢ Pre-filled Syringe   The initial starting dose is 150-225 IU/day commencing on mense day 2. The dose is adjusted according to the ovarian response. Treatment is continued until adequate follicular development has been achieved.Maximum daily dose should not exceed 450 IU. Route of administration: subcutaneous 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  1.Infertile women between 20-39 years of age
2.Basal FSH less than 10 IU/L
3.Regular menstrual cycles of 24to 35 days of duration
4.Antral size follicles more than 5
5.Normal functional ovaries and uterus
6.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 more than 30 kg/m2
4.Subjects with previous history of ovarian hyperstimulation syndrome 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.HIV or syphilis positive subjects
10.History of alcohol or drug addiction
11.Subjects smoking more than 5 cigarettes per day
12.History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug
13.Positive serum pregnancy test
14.Undiagnosed vaginal bleeding
15.Subjects unable to understand the objectives, methods, etc. of this clinical study and are unable to comply with the study procedures
16.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 
Total number of oocytes retrieved   At the end of one IVF cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Total administration dosage of rhFSH
Duration of rhFSH stimulation
E2 concentration on the day of hCG administration
Number of follicles more than 16mm in diameter on the day of hCG administration
Number of follicles more than or equal to 14 mm 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 OHSS
Compliance score
Patient assessment for use  		 At the end of one IVF cycle 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/07/2012 
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="6"
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, randomised, parallel active controlled phase IV study to compare and evaluate the clinical efficacy, safety and patient compliance of Newmon-Râ„¢ (rhFSH) Pre-filled Syringe with Gonal-F® Pen 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. 120 patients will be enrolled and data will be analysed using appropriate statistical tests.  
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