| CTRI Number |
CTRI/2017/11/010317 [Registered on: 01/11/2017] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of Recombinant human menopausal gonadotrophin in treatment of infertility |
|
Scientific Title of Study
|
A randomized, open label, assessor-blind, parallel group, multi centre Phase III study to compare the efficacy and safety of r-hMG and HP-hMG in subjects undergoing controlled ovarian stimulation for ART |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV_R-HMG_16_03 Version 1 /7 Jun 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamini Rao |
| Designation |
Consultant Obs and Gynaec |
| Affiliation |
BACC Health Care Pvt. Ltd |
| Address |
BACC Health Care Pvt. Ltd. # 7 East Park Road, Kumara Park East,
Bangalore
KARNATAKA
560001
India |
| Phone |
9620220960 |
| Fax |
|
| Email |
drkaminirao@milann.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Divekar |
| Designation |
Head Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat Serums and Vaccines Ltd |
| Address |
Clinical Research and Pharmacovigilance department
Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House,
Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-4503456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Divekar |
| Designation |
Head Clinical Research and Pharmacovigilance |
| Affiliation |
Bharat Serums and Vaccines Ltd |
| Address |
linical Research and Pharmacovigilance department. Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House,
Nariman point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-4503456 |
| Fax |
022-45043200 |
| Email |
ganesh.divekar@bharatserums.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Ltd., 17th floor, Hoechst House, Nariman point, Mumbai 400 021 |
|
|
Primary Sponsor
|
| Name |
Bharat serums and Vaccines ltd |
| Address |
17th floor, Hoechst House, Nariman point, Mumbai
400021 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geeta Khanna |
Ajanta Research Centre |
Ajanta Hospital and IVF Centre, 765 ABC complex kanpur road alambagh
Lucknow
UTTAR PRADESH |
0522-4101017
ivfajanta@gmail.com |
| Dr Alka Kriplani |
All India Institute Of Medical Sciences |
room No. 1, Department of Obstetrics and Gyneacology, Ansari Nagar
New Delhi
DELHI |
09810828717
kriplanialka16@gmail.com |
| Dr C Mala Prakash |
Apollo Hospital |
154/11, Opp IIMB, Banerghatta Road, 560076
Bangalore
KARNATAKA |
9845036007
drmala.c@apollohospitals.com |
| Dr Jayashree Sridhar |
Choithram Hospital & Research Centre |
Manik Bagh Road, Indore - 452014
Indore
MADHYA PRADESH |
91-0731-2362491
sridharjayshree@rocketmail.com |
| Dr Rita Bakshi |
CK Birla Hospital |
A unit of CMRI Gopalpura Bypass road Gopalpura, Jaipur - 302018
Jaipur
RAJASTHAN |
9810143703
ritabakshi.ifc@gmail.com |
| Dr Girish Godbole |
Deenanth Mangeshkar Hospital and Research Cente |
near Mhatre Bridge, Erandawne, Pune 411004, Maharashtra
Pune
MAHARASHTRA |
020-4015177
gpgodbole@gmail.com |
| Dr Manisha Singh |
Fortis hospital Bangalore |
154/9, Bannergatta road, Opp IIM-B
Bangalore
KARNATAKA |
9900883986
manisha.singh@fortishealthcare.com |
| Dr Amit Shah |
Inamdar Multispeciality Hospital |
IVF centre depoartmet of obs and gyn Hospital building s no. 15 KPCT Mall fatima nagar
Pune
MAHARASHTRA |
9850298520
dramitshah@yahoo.com |
| Dr Anju Madhavan |
Maharaja Agrasen Hospital |
West Punjabi Bagh, New Delhi, 110026
New Delhi
DELHI |
9911286979
dranjumadhavan@gmail.com |
| Dr Kamini Rao |
Milann -A unit of BACC Healthcare pvt. Ltd |
A unit of BACC Healthcare pvt. LtdNo. 1109 , 24th Main road , ist Phase, JP Nagar Bangalore 560078.
Bangalore
KARNATAKA |
9620220960
drkaminirao@milann.co.in |
| Dr Kamini Rao |
Milann- A unit of BACC Health Care Pvt. Ltd |
# 7 East Park Road, Kumara Park East, Bangalore 560 001
Bangalore
KARNATAKA |
9620220960
drkaminirao@milann.co.in |
| Dr Rajan Vaidya |
Nawrosjee Wadia Maternity hospital |
Depar of obs and gynac acharya donde marg parel mumbai -12
Mumbai
MAHARASHTRA |
9820216088
drrajanvaidya@yahoo.co.uk |
| Dr Shalini Srivastava |
Om Surgical Center & Maternity Home |
SA 17/3, P-4, Sri Krishna Nagar, Paharia, Ghazipur Poad, Varanasi- 221007
Varanasi
UTTAR PRADESH |
0542-2588849
drshalinivns@gmail.com |
| Dr Bharati Dhorepatil |
Shree hospital |
Room no. 101, Siddarth Mansion,Opp Agapekhan Palace Nagar Road, Pune 411006
Pune
MAHARASHTRA |
9822043112
bdhorepatil@gmail.com |
| Dr Abha Majumdar |
Sir Ganga Ram Hospital |
Ground Floor, Consultant Obs and Gyn, Rajender Nagar, New Delhi
New Delhi
DELHI |
9810315807
abhamajumdar@hotmail.com |
| Dr Sanjeeva Reddy |
Sri Ramachandra Medical college and Research Institute |
No.1, Ramachandra Nagar Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9841031131
royalnsr@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Dr. Abha -Ethics Commitee Sir Ganga Ram Hospital |
Submittted/Under Review |
| Dr. Amit -Ethics Committee, Inamdar Multispeciality Hospital |
Submittted/Under Review |
| Dr. Anju- IEC Maharaja Agrasen Hospital |
Approved |
| Dr. Bharati-Ethics committee of Shree Hospital |
Approved |
| Dr. Girish- Institutional Ethics committee, Lata Mangeshkar Medical foundations Deenanath Mangeshkar Hospital and Research centre |
Approved |
| Dr. Jaishree Institutional Ethics Committee, Choithram Hospital and Research Centre |
Submittted/Under Review |
| Dr. Mala IECCS of Appollo Hospitals |
Submittted/Under Review |
| Dr. Rita-IEC CK Birla Hosptial |
Approved |
| Dr. Sanjeeva IEC - Sri Ramchandra hospital |
Approved |
| Fortis Hospital Ethics committee |
Approved |
| IIRRH-BACC healthcare institutional ethics committee |
Approved |
| IIRRH-BACC healthcare institutional ethics committee |
Approved |
| INSTITUTE ETHICS COMMITTEE. ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| Institutional Ethics Committee, N Wadia Maternity Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Om Research Centre |
Approved |
| Institutional Ethics Committee, Ajanta Hospital and IVF centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, Women undergoing infertility treatment (ART), aged 20 to 39 years, with less FSH and estradiol level , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
r-HMG-recombinant human menopausal gonadotrophin |
This is recombinant human menopausal gonadotrophin, will be given at dose of 150IU/day for 5 days, then at investigators discretion |
| Comparator Agent |
Menopur
HP-HMG |
This is highly purified human menopausal gondatrophin. will be given at 150 IU/day for 5 days then at investigators discretion. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Subject has an indication for ART using COS.
regular menstural cycle.
FSH level less
Estradiol level less,
AFC of 10- 25
BMI more than 18.5 and less than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1 history of >2 successive ART cycles without clinical pregnancy
2. history of any endocrine abnormality
3. history of OHSS
4. documented PCOS
5. having Ovarian abnormality
6. documented severe endometriosis
7. having submucosal fibroid
8. history of extrauterine pregnancy in past 3 months
9. History of miscarriages
10. Poor response to gonadotropin treatment
11. Positive HIV, Hepatits B, C
12. Known case of allergic, hypersensitive, to r-hmg, or its excipients.
13. history of other co morbid condition that prevent in participating in trial under investigators discretion.
14. history of addiction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of oocytes retrieved in the groups receiving r-hMG and HP-hMG |
end of dosing IP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ongoing pregnancy rate, |
end of study |
| To compare the total dose of drug needed |
End of dosing of IP |
| To compare the number of days of drug stimulation |
end of dosing of IP |
| to compare laboratory and imaging parameters |
sitmuation day 6, On HCG administration |
| to compare laboratory and imaging findings |
stimulation day 6, on day of HCG administration |
|
Target Sample Size
Modification(s)
|
Total Sample Size="171"
Sample Size from India="171"
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 3 |
Date of First Enrollment (India)
Modification(s)
|
03/03/2018 |
| 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="1"
Months="10"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomized, open label, parallel group, multi-center Phase III study to compare the efficacy and safety of r-hMG and HP-hMG in subjects undergoing controlled ovarian stimulation for ART. Women who are indicated to undergo ART for infertility, aged between 20 to 39 years of age, with no uterine or endocrinal abnormalities and willing to participate in the trial will be enrolled after fulfilling the eligibility criteria. The primary endpoint- number of oocyte retrieved will be captured once the IP administration is completed. The rate of pregnancy, laboratory parameters, and imaging findings will be compared between two groups.
|