| CTRI Number |
CTRI/2009/091/000888 [Registered on: 10/12/2009] |
| Last Modified On: |
29/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological
Other (Specify) [Recombinant] |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to study the effect of R-TPR-020 in patients undergoing treatment for infertility. |
Scientific Title of Study
Modification(s)
|
Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-020 in patients undergoing treatment for infertility. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RLS/TP/2009/04 Ver.2.0 dated 7th Oct 2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjeev Hegde |
| Designation |
Head Clinical Development |
| Affiliation |
Reliance Life Science Pvt. Ltd. |
| Address |
Reliance Clinical Research Services
Reliance Life Science Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678208 |
| Fax |
02267678222 |
| Email |
sanjeev.hegde@relbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjeev Hegde |
| Designation |
Head Clinical Development |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
Reliance Clinical Research Services
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678208 |
| Fax |
02267678222 |
| Email |
sanjeev.hegde@relbio.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjeev Hegde |
| Designation |
Head Clinical Development |
| Affiliation |
Reliance Life Science Pvt Ltd |
| Address |
Reliance Clinical Research Services
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678208 |
| Fax |
02267678222 |
| Email |
sanjeev.hegde@relbio.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Reliance Life Sciences Pvt. Ltd.
irubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road,
Rabale Navi Mumbai 400701 |
|
Primary Sponsor
Modification(s)
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road,
Rabale, Navi Mumbai 400701 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Not Applicable |
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Madhuri Patil |
Dr. Patil's Fertility & Endoscopy Clinic |
No. 1 Admirality, First Floor, Bannerghatta Road,-560029
Bangalore
KARNATAKA |
drmadhurip@rediffmail.com |
| Dr.Madhuri Patil |
Dr.Patil's Fertility & endoscopy clinic |
no.1, uma admirality, first floor, Bannerghatta road,-560029
Bangalore
KARNATAKA |
drmadhurip@rediffmail.com |
| Dr. Sukhpreet Patel |
Gynaec World Assisted Fertility Unit |
Kwality House, Ist floor, Kemp's Corner,,-400026
Mumbai
MAHARASHTRA |
patelsukhpreet@yahoo.co.in |
| Dr. Sohani Verma |
Indraprasth Apollo Hospital |
Mathura Road, Sarita Vihar,-110044
New Delhi
DELHI |
drsohaniverma@yahoo.co.in |
| Dr. Sanjay Patel |
Mayflower Women's Hospital |
Mayflower House, Memnagar,-380052
Ahmadabad
GUJARAT |
drsanjaypatel@mayflowerhospital.com |
| Dr. Ranjit Joshi |
Nashik Women's Hospital |
IInd floor, Ganorkar Hospital, Mumbai Naka,-
Nashik
MAHARASHTRA |
ranjit@nashikwh.com |
| Dr. Bharati Dhorepatil |
Pune Fertility Centre |
Crescent Exclusee, 1162/3, Shivaji Nagar,-411005
Pune
MAHARASHTRA |
dhorepatil@gmail.com |
| Dr. Ameet Patki |
ReGenesis Centre for Assisted Reproduction Endoscopy and Fetal Medicine |
IIIrd floor, Sadhana House, Worli,-400018
Mumbai
MAHARASHTRA |
ameet_patki@relbio.com |
| Dr. Kamini Rao |
Reproductive Medicine, BACC Health Care Pvt. Ltd. |
6/7, Kumara Krupa, High Grounds,-560001
Bangalore
KARNATAKA |
drkaminirao@gmail.com |
| Dr. Kiran Sekhar |
Sai Kiran Hospital & Kiran Infertility Centre |
Lane No. 10, 6-2966/4 Khairatabad,-400018
Hyderabad
ANDHRA PRADESH |
kiranivf@rediffmail.com |
| Dr. Sunita Tandulwadker |
Solo Clinic |
Panchratna, 24/1, Erandvane, Karve Road,-411004
Pune
MAHARASHTRA |
sunitart@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee on Clinical Trials, Indraprsth Apollo Hospital |
Approved |
| Ethics Committee, Shatabdi Hospital, Nasik |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| Ethics RUS, Mumbai |
Approved |
| IEC Consultant, Banglore |
Submittted/Under Review |
| Shree Hospital Ethics Comittee, Pune |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Infertile females undergoing for controlled ovarian hyperstimulation (COH).
or patients undergoing treatment for Polycystic ovarian syndrome (PCOS), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
R-TPR-020 |
Dose:200 IU, Route of Administration:Subcute, Frequency & Duration:Daily till atleast 3 follicles of size 17 mm are developed. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Female subjects age 18 years to 40 years (both inclusive) at the time of screening.
2.Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH) or patients undergoing treatment for Polycystic ovarian syndrome (PCOS).
3.Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening. |
|
| ExclusionCriteria |
| Details |
1.History of clinically significant endocrine related abnormality
2.History / presence of undiagnosed vaginal bleeding
3.History of primary ovarian failure
4.Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
5.History of clinically significant diseases, e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease
6.Use of hormonal preparations within one month prior to the start of FSH with the exception of thyroid medication. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the efficacy of R-TPR-020 in Hyper stimulation of ovaries. |
Mean number of oocytes retrieved 36 hours post rhCG administration |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Assessment of oestradiol levels on the day of rhCG administration
2.Evaluation of safety
|
1.The mean oestradiol levels on the day of rhCG administration
2.Evaluation of safety will be based on incidence of treatment-emergent adverse events, abnormal clinical as well as laboratory results from baseline to end of the study. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/12/2009 |
| Date of Study Completion (India) |
06/03/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, multicentric, open label, single arm clinical trial to evaluate the safety and efficacy of R-TPR-020 in infertile females undergoing controlled ovarian hyperstimalation or patients undergoing treatment for polycystic ovarian syndrome. Total 45 subjects will be enrolled across the centers in India. The primary outcome measure will be the number of oocyte retrived post 36 hours of beeta hCG administration. Study duration of study will be of 7 month (6 month recruitment, 2 weeks screening & 2 weeks treatment) |