REFCTRI/2009/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Sat, 12 May :43:10 GMT) CTRI Number CTRI/2009/091/ [Registered on: 19/08/2009] - Last Modified On 19/04/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No PMS Biological Randomized Factorial Trial To evaluate the efficacy and cost effectiveness of Two Treatment regimens for treating women requiring Invitro Fertilisation 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 n Population Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) BSV r-hfsh IV 1108 Designation Affiliation Protocol Number Details of Principal Investigator Dr. Sadhana Desai Phone Fax Designation Affiliation IVF & Infertility Clinic, 12, Spring Filed, 1st floor, 19th Vachha Gandhi Road, Gamdevi Details Contact Person (Scientific Query) Dr. Sadhana Desai Phone Fax Designation Affiliation IVF & Infertility Clinic, 12, Spring Filed, 1st floor, 19th Vachha Gandhi Road, Gamdevi Details Contact Person (Public Query) Dr. Sadhana Desai IVF & Infertility Clinic, 12, Spring Filed, 1st floor, 19th Vachha Gandhi Road, Gamdevi page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Bharat Serums and Vaccines Limited Type of Sponsor Source of Monetary or Material Support Primary Sponsor Details n Society of Assisted Reproduction ISAR 23A 2nd Floor, Elco Arcade,84, Hill road,bandra (west) , INDIA Other [Private association] Bharat Serums and Vaccines Ltd. 17th Floor, Hoechst House Nariman Point , INDIA List of Countries of Principal Investigator of Site Site Phone/Fax/ Dr. Nayana Patel Akansksha IVF Kaival Hospital, Anand Dr. Parikshit Tank Dr. Shefali Jain Dr. Hrishikesh Pai Dr. Nandita Palshetkar Dr. Kamini Rao Dr. Kanthi Bansal Dr. Himanshu Bavishi Ashwini Maternity and Surgical Hospital Asian Institute of Infertility Management & Dr. Shefali Jain Test Tube Baby Centre Babies & Us Fertility, IVF & ICSI Centre Babies & Us Fertility, IVF & ICSI Centre Bangalore Assisted Conception Centre Bansla Hospital & Safal Fertility Foundation,- 10-E, HIG Main road, Near Christian eminent School,LIG Circle, A. B. Road Indore MADHYA PRADESH 2nd Flr, IVF Dept.,Lilavati Hospital, Bandra (W) nd flr, IVF Department,Lilavati Hospital, Bandra (W) No. 6/7 Kumara Krupa Road,High Grounds Bangalore KARNATAKA 23 Hatkesh Society,,Na vrangpura Ahmadabad Bavishi Fertility Institute Next to Adani CNG & Gajarwala Flats,Paldi Cross Roads, Paldi nayana@ivfsurrogate.c om drsdjain@yahoo.com hdpai@hotmail.com nanditapalshetkar@hot mail.com ` kambacc@vsnl.com kanthimbansal@gmail.c om drhbavishi@gmail.com page 2 / 6

3 Dr. Jatin Shah Dr. Madhuri M. Patil Bombay Fertility Clinic and IVF Centre Dr. Patil's Fertility and Endoscopic centre Ahmadabad Kamaya Polyclinc, 66-C Motiwala Building,Gowalia Tank No. 1, Uma Admiralty, 1st floor,,above HDFC Bank, Bannerghatta road Bangalore KARNATAKA Dr. Abha Majumdar Genesis Centre J-431, New Rajendra Nagar,Main Shankar Rd. Market New Delhi DELHI Dr. Duru Shah GynaecWorld Kwality house, Above chinese room restaurant,kemps Corner Dr. Sadhana Desai IVF and Fertility Centre 12 Spring Filed, 1st floor,,19th Vacha Gandhi Rd, Gamdevi Dr. Rajul Tyagi Dr. Umesh Jindal Dr. Sujatha Kar JAVITRI HOSPITAL & TEST TUBE BABY CENTRE Jindal IVF and Sant Memorial nursing home Kar Clinic & Hospital Pvt Ltd,- Lucknow UTTAR PRADESH #3050 Sector 20/D,Dakshin Marg Chandigarh CHANDIGARH A-32, Unit 4, Not Applicable N/A Dr. G. A. Ramaraju Krishna IVF Clinic Z. P. Junction,,- Visakhapatnam ANDHRA PRADESH Dr. Jaideep Malhotra Dr. Mandakini Parihar Malhotra Test Tube baby Centre Mandakini Fertiliyt Clinic and IVF Centre,- Not Applicable N/A 48 Swastik park,,chembur Dr. Nalini Mahajan Mother & child Hospital D-59, Defense Colony,, New Delhi DELHI Dr. Manish Banker Pulse Women's Hospital 108 Swastik Society,Na vrangpura com l.com il.com com page 3 / 6

4 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Dr. Shreyas Padfaonkar Shreays Infetility & IVF Centre Dr. Sanjay Makhwana Dr Mridubhashini Govindrajan Vasundhara Hospital & Fertility Centre Womens Centre Ahmadabad Munshi Estate,,M. G. Road, Mulund (W) E. Road, Behind Durga Bari,Sardarpura Jodhpur RAJASTHAN Sri Ramakrishna hospital Campus,Sarojini Naidu Road Coimbatore TAMIL NADU mivfg@yahoo.com shreyas@siivf.com vasundharafertility@ya hoo.com ksg@womenscentreindi a.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? CLINICOM No Date Specified Not Available CLINICOM Submittted/Under Review No Date Specified Not Available Status Not Applicable Health Type Date No Date Specified Condition Infertility requiring IVF Intervention / Type Details page 4 / 6

5 Comparator Agent Intervention rfsh (Foligraf) 150IU Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Comparator Agent rfsh (Foligraf) 225IU Age From Age To Gender Details Inclusion Criteria 1. Women in the age group of 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 Exclusion Criteria 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 Computer generated randomization Centralized 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] 4 weeks page 5 / 6

6 Powered by TCPDF ( REFCTRI/2009/ Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 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 Total Sample Size=210 Sample Size from = No Date Specified 20/08/2009 Years= Months=0 Days=0 Completed 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. 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. page 6 / 6