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CTRI Number  CTRI/2020/11/029333 [Registered on: 24/11/2020] Trial Registered Prospectively
Last Modified On: 07/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study of hormones in infertile women undergoing IVF 
Scientific Title of Study   A Prospective, Randomized, Open-label, Concurrent-controlled, Three-arm Study to Compare the Clinical Efficacy and Tolerability of Different Follicle-stimulating Hormone (Endogen® HP, Sanzyme vs Fostimon®, IBSA) and Human Chorionic Gonadotropin (Pubergen® HP, Sanzyme vs Pregnyl®, MSD Ltd.) Combinations in Women Undergoing In Vitro Fertilization 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SANZ-FSH/hCG-01.Version 2.0 dated 07 October 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RITA BAKSHI 
Designation  IVF Specialist & Chairperson 
Affiliation  International Fertility Centre 
Address  H6 Second Floor Green Park Main New Delhi

New Delhi
DELHI
110016
India 
Phone  9555544421  
Fax    
Email  ritabakshi.ifc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkata Kishan Pokuri 
Designation  Head - Medical Affairs 
Affiliation  Sanzyme P Ltd 
Address  Department of Medical Affairs, II nd Floor, Room no 4, Plot No 13 Rd Number 2 Sagar Society Banjara Hills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  04048589999  
Fax    
Email  Kishan.pokuri@sanzyme.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkata Kishan Pokuri 
Designation  Head - Medical Affairs 
Affiliation  Sanzyme P Ltd 
Address  Department of Medical Affairs, II nd Floor, Room no 4, Plot No 13 Rd Number 2 Sagar Society Banjara Hills Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  04048589999  
Fax    
Email  Kishan.pokuri@sanzyme.com  
 
Source of Monetary or Material Support  
SANZYME P LTD, Plot no 13, Rd number 2, Sagar Society, Banjara Hills, Hyderabad, Telangana 500034 
 
Primary Sponsor  
Name  Sanzyme P Ltd 
Address  Plot no 13, Rd number 2, Sagar Society, Banjara Hills, Hyderabad, Telangana 500034 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR GITA KHANNA  Ajanta Hospital and IVF Centre  Department of Fertility Medicine, First floor, Room no 1, 765 ABC Complex Kanpur Road Alambagh Lucknow 226005
Lucknow
UTTAR PRADESH 		 9335913046

ivfajanta@gmail.com 
Dr Ratnabali Chakravorty  ILS Hospital  DD-6 Sector 1 Salt Lake city Kolkata 700064
Kolkata
WEST BENGAL 		 9836068958

ratnabali.dr@gmail.com 
Dr Rita Bakshi  International Fertility Centre  H-6, 2nd Floor Green Park (Main), New Delhi – 16
New Delhi
DELHI 		 9555544421

ritabakshi.ifc@gmail.com 
Dr Hrishikesh Dattatraya Pai  Lilavati Hospital and Research Centre  A-791, Bandra Reclamation, Bandra West, Mumbai 400050
Mumbai
MAHARASHTRA 		 9820057722

hdpai@hotmail.com 
Dr Vyshnavi Rao  Milann IVF Centre  Milann (Unit of BACC Health Care) No 7, East Park Road, Kumara Park East, Bangalore
Bangalore
KARNATAKA 		 9742619162

vyshnavirao@gmail.com 
Dr Kajal Mangukiya  ORKID IVF CENTRE  IVF Department, 5th & 6th Floor, Western Vesu Point, Near S D Jain School, Vesu , Surat, Gujarat
Surat
GUJARAT 		 7211178917

orkidmedilife@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
IEC-ARC Institutional Ethics Committee  Approved 
IIRRH BACC Healthcare IEC  Approved 
ILS Hospital Ethics committee  Approved 
Lilavati hospital and research centre IEC  Approved 
Nirmal hospital pvt ltd ethics committee  Approved 
RISAA IVF International Fertility Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Follicle Stimulating Hormone - ENDOGEN HP (Sanzyme P Ltd)  FSH will be given s.c. or i.m. (dose in the range of 150-225 IU) starting from day 2 to day 5 of the current menstrual cycle (C1) or an incremental dose not exceeding 600 IU per day (for the first 4 days) and then the dose of FSH will be optimally adjusted depending on the ovarian response monitored by serum E2 levels and TVUS measurement.FSH will be continued until at least two follicles ≥16 mm in diameter are observed on TVUS and serum E2 levels are appropriate for the total number of developing follicles, or as per clinical judgement. 
Comparator Agent  Follicle Stimulating Hormone - FOSTIMON (IBSA, Switzerland)  FSH will be given s.c. or i.m. (dose in the range of 150-225 IU) starting from day 2 to day 5 of the current menstrual cycle (C1) or an incremental dose not exceeding 600 IU per day (for the first 4 days) and then the dose of FSH will be optimally adjusted depending on the ovarian response monitored by serum E2 levels and TVUS measurement.FSH will be continued until at least two follicles ≥16 mm in diameter are observed on TVUS and serum E2 levels are appropriate for the total number of developing follicles, or as per clinical judgement. 
Comparator Agent  Human Chorionic Gonadotropin - Pregnyl (MSD)  A single trigger of hCG preparation of Pregnyl,5000 to 10000 IU, powder, and solvent for solution for s.c. or intramuscular (i.m.) injection (for final oocyte maturation and trigger) will be administered as per clinical judgement, once at least two follicles ≥16 mm in diameter are observed on TVUS. 
Intervention  Human Chorionic Gonadotropin - Pubergen HP (Sanzyme P Ltd)  A single trigger of hCG preparation of Pubergen® HP, Sanzyme 5000 to 10000 IU, powder, and solvent for solution for s.c. or intramuscular (i.m.) injection (for final oocyte maturation and trigger) will be administered as per clinical judgement, once at least two follicles ≥16 mm in diameter are observed on TVUS. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  37.00 Year(s)
Gender  Female 
Details  Subjects with all of the following criteria were considered for inclusion:
1. Women with unexplained infertility undergoing COS for their first or
second cycle of IVF with or without intracytoplasmic sperm injection
(ICSI), irrespective of the outcome of first IVF cycle with following
characteristics:
- Age >21 and ≤37 years.
- Ability to provide written informed consent voluntarily for study
participation, along with consent by partner or spouse.
- A BMI between 18.5 and 30 kg/m2.
- Basal FSH, luteinizing hormone (LH), E2, progesterone (P4) and
prolactin (PRL) levels within normal range in cycle 1 Day 1.
- Normal ovarian response: antral follicular count (AFC) ≥10 and
anti-Müllerian hormone (AMH) level ≥1.0 ng/mL but ≤3.5 ng/mL.
- Normal ovulatory cycles of 21 to 35 ±2 days inclusive.
2. TVUS documenting the presence of both ovaries, without evidence of
abnormality (e.g., no endometrioma) and normal adnexa (e.g., no
hydrosalpinx) within 6 months prior to randomization.
3. Normal or clinically insignificant haematology and blood chemistry
values.
4. Husband or male partner, or donor with normal sperm motility and
sperm count or with non-severe male factor infertility (defined as a semen
concentrate 5 to 15×106 /mL or sperm with progressive motility (type a+b)
10% to 32%), including mild-to-moderate oligospermia, with or without
asthenospermia. 
 
ExclusionCriteria 
Details  1. History of more than 2 unsuccessful induction cycles with FSH/
human menopausal gonadotropin (hMG) or hCG regimen or intolerability
to these regimens requiring discontinuation.
2. History of ≥3 clinically confirmed miscarriages.
3. Persistent ovarian cysts more than 10 mm in size for >1 cycle or
ovarian endometrioma.
4. Polycystic ovarian syndrome (PCOS).
5. Submucosal or intramural fibroids ≥5 cm or any other clinically
relevant pathology, which could impair embryo implantation or pregnancy
continuation.
6. Tumours and malformation of sexual organs incompatible with
pregnancy.
7. Hydrosalpinx that has not been surgically removed or ligated.
8. Stage III or IV endometriosis (per revised American Society for
Reproductive Medicine classification, 2012).
9. History of ectopic pregnancy.
10. Prior history of OHSS.
11. Hypersensitivity to study medication or its excipients.
12. Abnormal bleeding of undetermined origin.
13. Any significant systemic disease or endocrine disorders (pituitary,
thyroid, adrenal, pancreas, liver, or kidney) or any active condition
requiring treatment, which, according to the Investigator, might interfere
with the study.
14. Metabolic disorders such as uncontrolled type I or type II diabetes
mellitus.
15. Untreated hyperprolactinaemia.
16. Severe infections of the reproductive system such as tuberculosis and
sexually transmitted diseases.
17. Receiving donor oocytes
18. Known history of human immunodeficiency virus (HIV), hepatitis B
or C, or syphilis infection.
19. Use of the concomitant medication that might interfere with study
evaluation
20. Pregnancy, lactation, or contraindication to pregnancy
21. Current or past (last 12 months) abuse of alcohol or drugs
22. Participation in a concurrent clinical trial or in another trial within the
past 6 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Total number of mature oocytes retrieved   34 to 36 hours after hCG administration 
 
Secondary Outcome  
Outcome  TimePoints 
- Total dose of FSH
- Number of days of FSH stimulation
- Mean E2 serum concentration
- Number of mature follicles
- Follicle oocyte index (FOI)
- Follicular output rate (FORT)
- Number of mature oocytes
- Number of inseminated oocytes
- Mean embryo score
- Total number of embryos transferred, frozen, or discarded
- Fertilization rate
- Implantation rate
- Clinical pregnancy rate
- IVF cancellation rate
- Ongoing pregnancy rate
- Number of adverse events  		 At the end of the study 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
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)   07/12/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A Prospective, Randomized, Open-label, Concurrent-controlled, Three-arm Study to Compare the Clinical Efficacy and Tolerability of Different Follicle-stimulating Hormone (Endogen® HP, Sanzyme vs Fostimon®, IBSA) and Human Chorionic Gonadotropin (Pubergen® HP, Sanzyme vs Pregnyl®, MSD Ltd.) Combinations in Women Undergoing In Vitro Fertilization.
Primary Objective:
To evaluate the clinical efficacy of different follicle-stimulating hormone (FSH) (Endogen® HP, Sanzyme vs Fostimon®, IBSA) and different human chorionic gonadotropin (hCG) (Pubergen® HP, Sanzyme vs Pregnyl®, MSD
Ltd.) combinations, when administered to female subjects undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF)
Secondary Objectives:
- To evaluate additional efficacy of different FSH (Endogen® HP, Sanzyme vs Fostimon®, IBSA) and different hCG (Pubergen® HP, Sanzyme vs Pregnyl® HP, MSD Ltd.) combinations when administered to female subjects undergoing COS for IVF
- To evaluate safety of different FSH (Endogen® HP, Sanzyme vs Fostimon®, IBSA) and different hCG (Pubergen® HP, Sanzyme vs Pregnyl® HP, MSD Ltd.) combinations when administered to female subjects undergoing COS for IVF.
This is a multicentre, prospective, randomized, open-label, concurrent-controlled, three-arm clinical study.
All the eligible female subjects will be randomized in a 1:1:1 ratio to the following study arms and will receive the following study products:
Arm 1:
- FSH preparation of Endogen® HP, Sanzyme (for ovarian follicle stimulation) and
- hCG preparation of Pubergen® HP, Sanzyme (for final oocyte maturation and trigger)
Arm 2:
- FSH preparation of Fostimon®, IBSA (for ovarian follicle stimulation) and
- hCG preparation of Pubergen® HP, Sanzyme (for final oocyte maturation and trigger)
Arm 3:
- FSH preparation of Endogen® HP, Sanzyme (for ovarian follicle stimulation) and
- hCG preparation of Pregnyl®, MSD Ltd. (for final oocyte maturationand trigger)
The purpose of this noninferiority study is to evaluate the clinical efficacy and general tolerability of different FSH and hCG combinations when administered to subjects undergoing COS for IVF. All enrolled subjects will undergo downregulation using a flexible gonadotropin-releasing hormone (GnRH) antagonist regimen for COS. FSH will be given s.c. or i.m. (dose in the range of 150-225 IU) starting from day 2 to day 5 of the current menstrual cycle (C1) or an incremental dose not exceeding 600 IU per day (for the first 4 days) and then the dose of FSH will be optimally adjusted depending on the ovarian response monitored by serum E2 levels and transvaginal ultrasonography (TVUS) measurement. Approximately after 5 days of stimulation with FSH injection, GnRH antagonist (cetrorelix) will be administered subcutaneously (s.c.) following a flexible dose protocol i.e., dose according
to clinical judgement. Thus, each subject will receive cetrorelix injection. from Day 6 of the treatment cycle C1 along with FSH until the day of hCG administration. The FSH administration (plus GnRH antagonist) will be continued until at least two follicles ≥16 mm in diameter are observed on TVUS and serum E2 levels are appropriate as per clinical judgement for hCG trigger. Subjects fulfilling this criterion will be administered 5000 to 10000 IU of hCG
injection. After 34 to 36 hours of hCG injection, the mature oocytes will be retrieved, artificially fertilized, followed by Day 2 or Day 3 or Day 5 embryo transfer, and luteal phase support will be provided as per the site’s routine practice.
 
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