| CTRI Number |
CTRI/2009/091/000086 [Registered on: 19/08/2009] |
| Last Modified On: |
26/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized Factorial Trial |
Public Title of Study
Modification(s)
|
To evaluate the efficacy and cost effectiveness of Two Treatment regimens for treating women requiring Invitro Fertilisation |
Scientific Title of Study
Modification(s)
|
A Prospective, Multicentric, Randomized, Comparative, Open Label, Parallel Group Phase IV Study To Evaluate The Efficacy, Safety And Cost Effectiveness Of Minimal Stimulation Protocol Compared To Standard Stimulation Protocol For In vitro Fertilization In Indian Population |
| Trial Acronym |
comparison between different procedure in invitro fertilization |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BSV r-hFSH IV 1108 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sadhana Desai |
| Designation |
|
| Affiliation |
|
| Address |
IVF & Infertility Clinic, 12, Spring Filed, 1st floor,
19th Vachha Gandhi Road, Gamdevi
Mumbai
MAHARASHTRA
400007
India |
| Phone |
022-23805845 |
| Fax |
022-23802604 |
| Email |
skdesai38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sadhana Desai |
| Designation |
|
| Affiliation |
|
| Address |
IVF & Infertility Clinic, 12, Spring Filed, 1st floor,
19th Vachha Gandhi Road, Gamdevi
Mumbai
MAHARASHTRA
400007
India |
| Phone |
022-23805845 |
| Fax |
022-23802604 |
| Email |
skdesai38@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sadhana Desai |
| Designation |
|
| Affiliation |
|
| Address |
IVF & Infertility Clinic, 12, Spring Filed, 1st floor,
19th Vachha Gandhi Road, Gamdevi
Mumbai
MAHARASHTRA
400007
India |
| Phone |
022-23805845 |
| Fax |
022-23802604 |
| Email |
skdesai38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Serums and Vaccines Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Indian Society of Assisted Reproduction ISAR |
| Address |
23A 2nd Floor, Elco Arcade,84, Hill road,Bandra (west)Mumbai-400050, INDIA |
| Type of Sponsor |
Other [Private association] |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Bharat Serums and Vaccines Ltd |
17th Floor, Hoechst HouseNariman PointMumbai - 400 021, INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 24 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Nayana Patel |
Akansksha IVF |
Kaival Hospital,-388001
Anand
GUJARAT |
02692253789
nayana@ivfsurrogate.com |
| Dr. Parikshit Tank |
Ashwini Maternity and Surgical Hospital |
,-
Mumbai
MAHARASHTRA |
|
| Dr. Shefali Jain |
Asian Institute of Infertility Management & Dr. Shefali Jain Test Tube Baby Centre |
10-E, HIG Main road, Near Christian eminent School,LIG Circle, A. B. Road-452001
Indore
MADHYA PRADESH |
07312579595
drsdjain@yahoo.com |
| Dr. Hrishikesh Pai |
Babies & Us Fertility, IVF & ICSI Centre |
2nd Flr, IVF Dept.,Lilavati Hospital, Bandra (W)-400050
Mumbai
MAHARASHTRA |
02226438280
hdpai@hotmail.com |
| Dr. Nandita Palshetkar |
Babies & Us Fertility, IVF & ICSI Centre |
2nd flr, IVF Department ,Lilavati Hospital, Bandra (W)-400050
Mumbai
MAHARASHTRA |
02226438280
nanditapalshetkar@hotmail.com |
| Dr. Kamini Rao |
Bangalore Assisted Conception Centre |
No. 6/7 Kumara Krupa Road,High Grounds-560001
Bangalore
KARNATAKA |
08022260880`
kambacc@vsnl.com |
| Dr. Kanthi Bansal |
Bansla Hospital & Safal Fertility Foundation |
23 Hatkesh Society,,Navrangpura-380014
Ahmadabad
GUJARAT |
08026440365
kanthimbansal@gmail.com |
| Dr. Himanshu Bavishi |
Bavishi Fertility Institute |
Next to Adani CNG & Gajarwala Flats,Paldi Cross Roads, Paldi-380007
Ahmadabad
GUJARAT |
07926631722
07927484334
drhbavishi@gmail.com |
| Dr. Jatin Shah |
Bombay Fertility Clinic and IVF Centre |
Kamaya Polyclinc, 66-C Motiwala Building,Gowalia Tank-400026
Mumbai
MAHARASHTRA |
02223887865
02223873196
drjain2000@yahoo.com |
| Dr. Madhuri M. Patil |
Dr. Patil's Fertility and Endoscopic centre |
No. 1, Uma Admiralty, 1st floor,,Above HDFC Bank, Bannerghatta road-560029
Bangalore
KARNATAKA |
08041201357
drmadhurip@rediffmail.com |
| Dr. Abha Majumdar |
Genesis Centre |
J-431, New Rajendra Nagar,Main Shankar Rd. Market-110060
New Delhi
DELHI |
abhamajumdar@hotmail.com |
| Dr. Duru Shah |
GynaecWorld |
Kwality house, Above chinese room restaurant,Kemps Corner-400026
Mumbai
MAHARASHTRA |
02223802584
02223804839
durushah@hotmail.com |
| Dr. Sadhana Desai |
IVF and Fertility Centre |
12 Spring Filed, 1st floor,,19th Vacha Gandhi Rd, Gamdevi-400007
Mumbai
MAHARASHTRA |
02223805845
022-23802604
skdesai38@gmail.com |
| Dr. Rajul Tyagi |
JAVITRI HOSPITAL & TEST TUBE BABY CENTRE |
,-
Lucknow
UTTAR PRADESH |
|
| Dr. Umesh Jindal |
Jindal IVF and Sant Memorial nursing home |
#3050 Sector 20/D,Dakshin Marg-160020
Chandigarh
CHANDIGARH |
01722727773
01725086744
unjindal@gmail.com |
| Dr. Sujatha Kar |
Kar Clinic & Hospital Pvt Ltd |
A-32, Unit 4,-751001
|
06742516666
06742530555
suju63@yahoo.com |
| Dr. G. A. Ramaraju |
Krishna IVF Clinic |
Z. P. Junction,,-
Visakhapatnam
ANDHRA PRADESH |
08912538194
08912706712
|
| Dr. Jaideep Malhotra |
Malhotra Test Tube baby Centre |
,-
|
|
| Dr. Mandakini Parihar |
Mandakini Fertiliyt Clinic and IVF Centre |
48 Swastik park,,Chembur-400071
Mumbai
MAHARASHTRA |
02225296666
02225233672
mandakiniparihar@gmail.com |
| Dr. Nalini Mahajan |
Mother & child Hospital |
D-59, Defense Colony, ,-110024
New Delhi
DELHI |
01124656736
01124521727
nalinimahajan@hotmail.com |
| Dr. Manish Banker |
Pulse Women's Hospital |
108 Swastik Society,Navrangpura-380009
Ahmadabad
GUJARAT |
07926422626
07926422616
mivfg@yahoo.com |
| Dr. Shreyas Padfaonkar |
Shreays Infetility & IVF Centre |
Munshi Estate, ,M. G. Road, Mulund (W)-400080
Mumbai
MAHARASHTRA |
09867780436
shreyas@siivf.com |
| Dr. Sanjay Makhwana |
Vasundhara Hospital & Fertility Centre |
716 E. Road, Behind Durga Bari,Sardarpura-342003
Jodhpur
RAJASTHAN |
02912613981
02912625853
vasundharafertility@yahoo.com |
| Dr Mridubhashini Govindrajan |
Womens Centre |
Sri Ramakrishna hospital Campus,Sarojini Naidu Road-641044
Coimbatore
TAMIL NADU |
04224201000
04224201024
ksg@womenscentreindia.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 24 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
|
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Submittted/Under Review |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
| CLINICOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, Infertility requiring IVF, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
rFSH (Foligraf) |
150IU |
| Comparator Agent |
rFSH (Foligraf) |
225IU |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
1. Women in the age group of 18 37 years (both inclusive) with normal ovulatory cycles
2. Women with body mass index (BMI) between 20 and 30 kg/m2
3. Women with primary or secondary Infertility
4. Women with negative urine pregnancy test (UPT)
5. Women with normal or clinically insignificant hematology and blood chemistry values.
6. Women whose male partner does not require surgical sperm retrieval [Percutaneous epididymal sperm aspiration (PESA) or Testicular epididymal sperm aspiration (TESA)].
7. Women with FSH, LH, Estradiol (E2),Progesterone (P4) at luteal phase, and Prolactin levels within normal range
8. Women with both intact ovaries. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalpinx) within 6 months before randomization
9. Male with normal sperm motility and sperm count more than 4 million/mL
|
|
| ExclusionCriteria |
| Details |
1. Women with gonadal failure or premature ovarian failure
2. Women with FSH >10 IU/L
3. Women with thyroid or adrenal dysfunction
4. Women with PCOS, endometrioma (endometrial thickness >4mm) or any other active pelvic pathology
5. Women with untreated fibroid tumors of the uterus of <4 cm in size (incompatible with pregnancy), including untreated submucous myoma and 12 weeks adenomyomas
6. Women with >3 previously unsuccessful IVF cycles or previous IVF cycle with unsuccessful fertilization
7. Women with history of recurrent miscarriage
8. Women with tumors of the ovary, breast, uterus, pituitary or hypothalamus and malformations of the sexual organs (incompatible with pregnancy)
9. Women with history of diabetes or hypertension or any other systemic disorder and on treatment for the same
10. Women mentally incompatible for conception
11. Women with history of hypersensitivity to any excipients of the investigational products
12. Women who are taking concomitant medications that might interfere with study evaluations
13. Women who have participated in another study or received any investigational product 30 days prior to enrolment or simultaneous participation in another clinical study
14. Women who are poor responders to FSH
15. Women with complete or partial hysterectomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Mean percentage of grade 1 oocytes retrieved
2. Mean percentage of fertilization rate |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Mean total dose in IU required to achieve follicle size ≥18 mm in diameter (from the day of r-hFSH administration to the Day of Human Chorionic Gonadotropin [HCG] administration)
2. Percentage of Clinical Pregnancy rate
3. Number of mature and immature oocytes
4. Ratio of mature and immature oocytes
5. Number of grade I embryos
6. Percentage of Chemical Pregnancy rate
7. Mean days of stimulation with r-hFSH required to achieve follicle size ≥18 mm in diameter
8. Risk of OHSS
9. Incidence & Absolute Frequency of AE?s reported in the trial which were related to study drugs administered in Group A & Group B
|
4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="210"
Sample Size from India="210"
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 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised open label multi-centre trial to compare the efficacy and safety of the Minimal stimulation protocol vis-a-vis the standard protocol for artificial reproduction (using ICSI) with rFSH (Foligraf), manufactured by Bharat Serums and Vaccines Ltd. The study is being conducted at 24 centres in India. Thr primary outcome is number of grade 1 oocytes and mean percentage of fertilisation rate. The secondary outcomes are percentage of clinical pregnancy, mean dose of rFSH and incidence of AEs. |