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-M™ (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-M™ (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
|
|
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
|
|
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 |
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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-M™ 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. |