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CTRI Number  CTRI/2019/10/021801 [Registered on: 25/10/2019] Trial Registered Prospectively
Last Modified On: 21/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of hormones in infertile women undergoing IVF 
Scientific Title of Study   A Prospective, Randomized, Open-Label, Controlled, Clinical Study to Compare the Clinical Efficacy and Tolerability of Two Highly Purified Human Menopausal Gonadotropin Preparations Administered Subcutaneously in Women Undergoing In Vitro Fertilization 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SAN-hMG-01 Version 1.0 dated 31 Jan 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kamini A Rao 
Designation  Medical Director 
Affiliation  Milann IVF Center 
Address  Department of Fertility and Reproductive Medicine, Ground Floor, Room no 7, 7E Park Rd Kumara Park East Seshadripuram Bengaluru

Bangalore
KARNATAKA
560001
India 
Phone  08022011333  
Fax    
Email  drkaminirao@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkata Kishan P 
Designation  Head of Medical Affairs 
Affiliation  Sanzyme P Ltd 
Address  Department of Medical Affairs, II nd Floor, Room no 4, Sanzyme P Ltd Plot 13 Sagar Society Road no 2 Banjara Hills Hyderabad

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

Hyderabad
TELANGANA
500034
India 
Phone  04048589999  
Fax    
Email  drkishan@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  
No of Sites = 5  
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 Himanshu Bavishi  Bavishi Fertility Institute  Department of Reproductive Medicine, Division I,Room no 2, Paldi Cross roads Paldi Ahmedabad 380007
Ahmadabad
GUJARAT 		 9825072277

drhbavishi@gmail.com 
Dr Renu Jain  GP Shekawati Hospital and Research Centre  Department of Fertility Medicine, Ground Floor, Room no 1, opposite Times Square Central Spine Vidyadhar Nagar Jaipur 302039
Jaipur
RAJASTHAN 		 9001995302

drrenujain1@gmail.com 
Dr Kamini Rao  Milann IVF Centre  Department of Fertility and Reproductive Medicine, Ground Floor, Room no 7, 7 East Park Road Kumara Park East Bangalore 560001
Bangalore
KARNATAKA 		 08022343391

drkaminirao@gmail.com 
Dr Sanjeeva Reddy  Sri Ramachandra Insitute of Higher Education and Research  Senior Consultant, Department of Reproductive Medicine and Surgery,Unit - 1, Sri Ramachandra Hospital, Porur Chennai 600116
Chennai
TAMIL NADU 		 04445928544

royalnsr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bavishi Hospital Ethics Committee  Approved 
IEC Sri Ramachandra institute of Higher Education and Research  Approved 
IEC- GP Shekhawati Hospital Research centre  Approved 
IEC-ARC Institutional Ethics Committee  Approved 
IIRRH-BACC Healthcare IEC  Approved 
Nirmal hospital pvt ltd ethics committee  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  Human Menopausal Gonadotropin - Gynogen HP (Sanzyme Pvt. Ltd, India)  A starting dose of Gynogen® HP 150 IU-225 IU will be maintained for approximately first 4-5 days. Dose adjustment will be allowed depending on the ovarian response monitored by means of serum E2 levels and TVUS measurement. hMG + GnRH agonist will be continued until at least two follicles are ≥14 to 16 mm in diameter. 
Comparator Agent  Human Menopausal Gonadotropin - Menopur (Ferring Pharmaceuticals, Inc.)  A starting dose of Menopur 150 IU-225 IU will be maintained for approximately first 4-5 days. Dose adjustment will be allowed depending on the ovarian response monitored by means of serum E2 levels and TVUS measurement. hMG + GnRH agonist will be continued until at least two follicles are ≥14 to 16 mm in diameter. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Women undergoing COS for their first or second cycle of IVF with or without intracytoplasmic sperm injection (ICSI) with following characteristics:
- Age > 21 and ≤ 40 years
- Ability to provide written informed consent voluntarily for study participation, along with consent by partner or spouse
- Body mass index between 18.5 and 30 kg/m2
- Basal FSH, LH, E2, P4 at luteal phase and prolactin (PRL) levels within normal range
- Normal antral follicle count (AFC) (6 to 10)
- Normal ovulatory cycles of 21 to 35 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/male partner with normal sperm motility and sperm count. 
 
ExclusionCriteria 
Details  1. History of more than 2 unsuccessful induction cycles with hMG or hCG regimen or intolerability to regimens requiring discontinuation.
2. Primary or secondary ovarian failure or women known as poor responders.
3. Patient with a history of ≥3 miscarriages.
4. Presence of only one ovary or ovarian abnormality or ovarian cysts >10 mm in size for >1 cycle or ovarian endometrioma.
5. Patients with polycystic ovary syndrome.
6. Hydrosalpinx that have not been surgically removed or ligated.
7. Stage III or IV endometriosis.
8. Abnormality on endometrial biopsy.
9. Patients with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation
10. Tubal pathologies or history of ectopic pregnancy.
11. Prior history of OHSS.
12. Allergy, intolerance, or hypersensitivity to the study medication or its excipients.
13. Abnormal bleeding of undetermined origin.
14. Any history of malignancy or significant systemic disease (cardiovascular, gastrointestinal, pulmonary, neurological, or
autoimmune), endocrine or metabolic abnormalities (pituitary,thyroid, adrenal, pancreas, hepatic or renal), or any active condition requiring treatment, which, according to the investigator, might interfere with the study.
15. Metabolic disorders such as type I or type II diabetes mellitus.
16. Tumours and malformation of sexual organs incompatible with pregnancy.
17. Hyperprolactinaemia.
18. Women with severe infections of the reproductive system such as tuberculosis, sexually transmitted diseases, etc.
19. Known positive history of human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
20. Abnormality in the partner’s semen based on semen analysis.
21. Use of concomitant medication that might interfere with ovulation (e.g., neuroleptics) or study evaluations, or concomitant
medications with known or suspected teratogenic agents (e.g., Food and Drug Administration Class X drugs).
22. Pregnancy, lactation, or contraindication to pregnancy.
23. Current or past (last 12 months) abuse of alcohol or drugs; women who smoke or have stopped smoking in the past 3 months.
24. 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 human
chorionic gonadotropin (hCG) administration 
 
Secondary Outcome  
Outcome  TimePoints 
- Drug utilization in terms of total dose of hMG (IU, total number of vials, and vials per day)
- Stimulation duration in terms of number of days of hMG stimulation (from stimulation onset until hCG injection)
- Mean 17β-oestradiol (E2) serum concentration on the day of hCG injection
- Success rate
- Mean Embryo score
- Fertilization rate
- Implantation rate
- Clinical Pregnancy rate
 		 At the end of the study 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/11/2019 
Date of Study Completion (India) 04/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
A prospective, randomized, open-label, controlled, clinical study to compare the clinical efficacy and tolerability of two highly purified human menopausal gonadotropin preparations administered subcutaneously in women undergoing in vitro fertilization.

Primary Objective:
To evaluate the clinical efficacy of two different highly purified (HP) human menopausal gonadotropin (hMG) preparations (Gynogen® HP and Menopur®), when administered subcutaneously (s.c.) to female patients undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) on oocyte maturation and retrieval.

Secondary Objective:
To evaluate additional clinical efficacy, tolerability, and safety of two different HP-hMG preparations (Gynogen® HP and Menopur®), when administered s.c. to female patients undergoing COS for IVF.

This is a multicentre, prospective, randomized, open-label, controlled, parallel-group trial.

The purpose of this non-inferiority study is to compare the clinical efficacy and general tolerability of two different HP-hMG preparations (Gynogen®HP; Sanzyme Pvt. Ltd. and Menopur®, Ferring Pharmaceuticals, Inc.) when
administered s.c. to female patients undergoing COS for IVF. Eligible patients will be randomized in a 1:1 ratio to receive either the Test hMG (Gynogen® HP) or the Reference hMG (Menopur®) products.
Enrolled patients will undergo down-regulation using a standard gonadotropin-releasing hormone (GnRH) agonist long regimen with leuprolide. Leuprolide acetate 0.5 mg subcutaneously will be administered starting from Day 21 of the previous menstrual cycle (C0). After the downregulation, hMG administration will be initiated at 150-225 IU daily starting from Day 1/2 of the current menstrual cycle (C1). This dose will be maintained for approximately first 4-5 days. The patient will also continue to receive GnRH agonist simultaneously; the dose of leuprolide acetate will be decreased to 0.25 mg starting on Day 3 of Cycle 1 and continued daily until the day of hCG administration. Thereafter, hMG dose adjustments will be allowed depending on the ovarian response monitored by means of serum E2 levels and transvaginal ultrasonography (TVUS). Patients will be routinely monitored via TVUS and hormonal profiling of follicle-stimulating hormone (FSH), luteinizing hormone (LH), E2, and progesterone (P4) levels.

The hMG administration (+ GnRH agonist) will be continued until at least two follicles ≥14 to 16 mm in diameter are observed on TVUS and serum E2 levels are appropriate for the total number of developing follicles, or as per
Investigator’s clinical judgement. Patients fulfilling this criterion will be administered 5000-10,000 IU hCG (Pubergen® only; will be provided as part of the study drugs supplies) injection.
After 34-36 hours of hCG injection, the mature oocytes will be retrieved and artificially fertilized.
Luteal phase support will be performed as per the site’s routine practice.
 
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