| CTRI Number |
CTRI/2010/091/000852 [Registered on: 18/06/2010] |
| Last Modified On: |
01/08/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical trial to test efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing IVF |
|
Scientific Title of Study
|
A prospective, multicenter, randomized, open, comparative clinical trial to test efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing their first cycle of invitro fertilization with intracytoplasmic sperm injection (ICSI). |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSV/Folliculin-HP/09 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Mandakini Parihar |
| Designation |
|
| Affiliation |
|
| Address |
Gynecologist and Fertility Specialist,Mandakini IVF Centre,
48, Swastik Park, Chembur
Mumbai
MAHARASHTRA
400 071
India |
| Phone |
022-25224845, 25227539 |
| Fax |
|
| Email |
map@parihar.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mandakini Parihar |
| Designation |
|
| Affiliation |
|
| Address |
Gynecologist and Fertility Specialist,Mandakini IVF Centre,
48, Swastik Park, Chembur
Mumbai
MAHARASHTRA
400 071
India |
| Phone |
022-25224845, 25227539 |
| Fax |
|
| Email |
map@parihar.com |
|
Details of Contact Person
Public Query
|
| Name |
Naju Turakhia |
| Designation |
|
| Affiliation |
|
| Address |
Bharat Serums and Vaccines Limited,
17th Floor, Hoechst House, Nariman Point,
Mumbai
MAHARASHTRA
400021
India |
| Phone |
022-66560956 |
| Fax |
022-66560901 022-66560901 |
| Email |
naju.t@bharatserums.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
Modification(s)
|
| Name |
Bharat Serums and Vaccines Limited |
| Address |
17th floor, Hoechst House, Nariman Point
Mumbai
MAHARASHTRA
400021
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Himanshu Bavishi |
Bavishi Fertility Institute |
Opp Muncipal Garden,Paldi Cross Road, Paldi, -380007
Ahmadabad
GUJARAT |
07926574901
drbavishi@ivfclinic.com |
| Dr. Mandakini Parihar |
Mandakini IVF Centre |
48, Swastik Park,Chembur -400 071
Mumbai
MAHARASHTRA |
022-25224845, 022-25227539
map@parihar.com |
| Dr Manish Banker |
Pulse Hospital |
Swastik Society,, Near Samved Hospital, Navrangpura-380008
Ahmadabad
GUJARAT |
+919904401070
mivfg@yahoo.com |
| Dr Monu Patnayak |
Shanti Memorial Hospital |
Udit Nagar,-769012
|
0661-2500204
monuse123@hotmail.com |
| Dr. M.N. Chimote |
VAUNSHDHARA TEST TUBE BABY CENTRE |
9 , Dr. Munje Marg ,Congress Nagar -440012
Nagpur
MAHARASHTRA |
07122443491
mnchimote@vaunshdharaivf.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
| Clinicom |
Approved |
| Clinicom |
Approved |
| Clinicom |
Approved |
| Clinicom |
Approved |
| Ethics Committee, Bavishi Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infertility in female, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Highly Purified Follicle Stimulating Hormone - Comparator drug |
2 to 4 vials of 75 IU will be administered subcutaneously per day for about 8 - 12 days |
| Intervention |
Highly Purified Follicle Stimulating Hormone - Test drug |
2 to 4 vials of 75 IU will be administered subcutaneously per day for about 8 - 12 days. |
|
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Inclusion Criteria
|
| Age From |
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| Age To |
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| Gender |
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| Details |
1. Subjects undergoing first cycle of invitro fertilization with Intracytoplasmic sperm injection (ICSI)
2. Subjects aged >18 and <35 years
3. Normogonadotrophic subjects with normal FSH and LH levels
4. Semen parameters compatible with Intracytoplasmic sperm injection (ICSI)
5. Hysterosalpingography or hysteroscopy documenting a uterus consistent with expected normal function
6. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality |
|
| ExclusionCriteria |
| Details |
1. Subjects > 35 years of age.
2. Infertility attributable to severe endometriosis (grade III or IV)
3. Subjects with previous failed IVF or IVF with ICSI cycle
4. Pelvic pathology that would compromise invitro fertilization (IVF) success
5. Tumors and malformation of sexual organs incompatible with pregnancy
6. Hypersensitivity to any trial product
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1. Total number of eggs 2. Total number of mature oocytes retrieved 3. No. of HP FSH vials used 4. Total days of FSH stimulation |
End of study - 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Number of embryos cleaved 2. Clinical pregnancy rate 3. Incidence of severe OHSS - Grade IV to VI 4. Cancellation Rate |
End of study - 6 weeks |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
1. This study is a randomised open label multi-centre trial to compare the efficacy and safety of 2 brands of highly purified follicle-stimulating hormone in subjects undergoing their first cycle of invitro fertilization with intracytoplasmic sperm injection (ICSI). The study is being conducted at 5 centres in India. The primary outcomes are total number of eggs, total number of mature oocytes retrieved, no. of HP FSH vials used, total days of FSH stimulation. The secondary outcomes are number of embryos cleaved, clinical pregnancy rate, incidence of severe OHSS - Grade IV to VI and cancellation rate. |