CTRI/2025/07/090950 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On:
19/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study to investigate Safety, Efficacy and Immunogenicity of recombinant human follicle stimulating hormone (r-hFSH) in Adult Female undergoing assisted reproductive technology.
Scientific Title of Study
A Randomized, Assessor-Blind, Active-Controlled, Parallel Group, Two-Arm,
Phase-3 Study To Compare Safety, Efficacy and Immunogenicity of R-hFSH (Recombinant Human
Follicle Stimulating Hormone (Follitropin Alfa) Injection of Intas Pharmaceuticals Ltd., With
Recombinant Human Follicle Stimulating Hormone (r-hFSH) Follitropin Alfa (Gonal-F) of Merk
Serono Ltd. in Adult Females Undergoing Assisted Reproductive Technology.
Department of Clinical research, Room No. NA, A4 Hospitals and fertility centre, No 87 Arcot road, AVM Avenue near vembuliamman Kovil, Virugambakkam, Chennai-600092, Tamil Nadu
Chennai TAMIL NADU
8925846176
aruna@a4fertility.com
Dr Nayana Patel
Akankasha Hospital & Research Insitute
Department of Clinical research, Room No. NA, Nr. Shrishti English Medium School, Opp. Guru Villa Bungalows, Lambhvel-387310, Anand, Gujarat
Anand GUJARAT
9825158227
nayana@ivf-surrogate.com
Dr Neena Malhotra
All India institute of medical sciences
Department of Obstetrics and Gynaecology, Room No. NA, Mother and child block, AIIMS Ansari Nagar New Delhi- 110029
New Delhi DELHI
9891557707
malhotraneenaaiims@gmail.com
Dr Manish Banker
Dr Banker Healthcare Private Limited
Department of Clinical research, Room No. NA, 108 Swastik Society, Near St Xaviers Ladies Hostel, Navarangpura, Ahmedabad- 380009, Gujarat
Ahmadabad GUJARAT
9824026659
manishbanker1@gmail.com
Dr Mousumi Acharya
Kalinga Institute of medical sciences
Department of Clinical research, Room No. NA, Kalinga institute of medical sciences (KIMS) Kushabhadra campus 5, Kiit road,Bhubaneshwar- 751024, India
Bhadrak ORISSA
9556026322
macharya39@yahoo.com
Dr Rashmi Sharma
Origyn Fertility & IVF
Department of Clinical
research, Room No.
NA, 4th Floor, H.B Twin Tower, NSP Pitampura, New Delhi- 110034
New Delhi DELHI
9810252619
drrashmisharma73@gmail.com
Dr Shalini Gainder
Post graduate institute of medical education and research, Dr. Shalini Gainder
Department of Clinical research, Room No. NA, Department of gynecology, 2nd floor, new OPD, Post graduate institute of medical education and research, sector-12, Chandigarh- 160012.
Chandigarh CHANDIGARH
7087008345
sgainder@gmail.com
Dr Sachin Kulkarni
Sunanda IVF and Fertility Clinic
Department of Clinical research, Room No. NA,, Square 9 Building, 395/2. E Ward, Assembly Rd, Opp- IDBI Bank, Near Basant Bahar Theater, Kolhapur, Maharashtra- 416001
Kolhapur MAHARASHTRA
9325693232
drsachinivf@gmial.com
Dr R G Patel
sunflower womens endofertility & hospital Pvt.Ltd
Department of Clinical research, Room No. NA, Sunflower Hospital, Ground floor, Helmet Circle, Drive in Road, near manav Mandir road, opposite Traffic police, memnagar, Ahmedabad, 380052, Gujarat, India
Ahmadabad GUJARAT
Good Society For Ethical Research, Dr. Rashmi Sharma
Approved
Institutional ethics committee, Dr. Mousumi Acharya
Approved
Institutional ethics committee, Dr. Neena Malhotra
Approved
Institutional ethics committee, Dr. Shalini Gainder
Approved
KCC Institutional Ethics Committee, Dr. Sachin Kulkarni
Approved
KVTSH- Institutional Ethics committee, Dr. Aruna Ashok
Approved
Sat Kaival Hospital Pvt. Ltd. Ethics Committee, Dr. Nayana Patel
Approved
Shrey Institutional Ethics committee, Dr. R. G Patel
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,
Intervention / Comparator Agent
Type
Name
Details
Intervention
R-hFSH (Recombinant Human Follicle
Stimulating Hormone (Follitropin alfa))
injection-test (T)
Dose: The starting dose of r-hFSH is 225 IU and fixed for the first five stimulation days, after which it may be adjusted by 75 IU based on the individual response. The maximum daily r-hFSH dose allowed is 450 IU. Dosing will continue until the criterion for triggering of final follicular maturation has been met. Participants can be treated with r-hFSH for a maximum of 20 days,
Frequency: Beginning on cycle day 2 or 3, investigational intervention is administered subcutaneously daily for 5 days, additional doses of Investigational intervention may be administered (as applicable preferably maximum up to 20 doses),
Route of administration: Subcutaneous,
Total duration: The injection should be given at the same time each day.
Comparator Agent
Recombinant human follicle stimulating
hormone (r-hFSH) follitropin alfa (GONAL-f)-reference (R)
Dose: The starting dose of r-hFSH is 225 IU and fixed for the first five stimulation days, after which it may be adjusted by 75 IU based on the individual response. The maximum daily r-hFSH dose allowed is 450 IU. Dosing will continue until the criterion for triggering of final follicular maturation has been met. Participants can be treated with r-hFSH for a maximum of 20 days,
Frequency: Beginning on cycle day 2 or 3, investigational intervention is administered subcutaneously daily for 5 days, additional doses of Investigational intervention may be administered (as applicable preferably maximum up to 20 doses),
Route of administration: Subcutaneous,
Total duration: The injection should be given at the same time each day.
Inclusion Criteria
Age From
21.00 Year(s)
Age To
38.00 Year(s)
Gender
Female
Details
1) Must sign an ICF indicating that the participant understands the purpose of, and procedures
required for the study as described in Appendix 10.1.3 and in this protocol and is willing to
participate in the study.
2) Female with menstrual cycle of 21-35 days (maximum up to 42 days) presumed to be ovulatory,
who desires pregnancy and is eligible for ART.
3) Age of 21 to 38 at the time of signing the informed consent.
4) BMI within 18-35 kg per m2 (inclusive) at screening.
5) Participants with minimum of one menstrual cycle without treatment with fertility modifiers
(E.g., Clomiphene Citrate; Participants with these drug use can be considered after appropriate
washout period is completed before screening) as determined by the investigator at the time of
signing the informed consent.
6) Documented history of infertility - means unable to conceive for at least 12 months in less than 35 years
or for at least 6 months if receiving donor sperm OR greater than 35 years with following laboratory
parameters to be assessed: i) A Day 2 or Day 3 (early follicular phase) serum FSH level between 1 and 12 IU per L (or 1 and
12 mIU per mL) (both inclusive), the results of which should be obtained within 3 months prior
to randomization or at randomization.
ii) Antral follicle count greater than 5 follicle and antral mullerian hormone level (AMH) greater than 0.5 ng per mL (or
greater than 3.57 pmol per L) at screening or within 3 months prior to randomization as determined by
investigator.
7) Ultrasonographic examination (transvaginal and or abdominal) documenting presence and
adequate visualization of both ovaries and adnexa, without evidence of significant abnormality
(e.g., hydrosalpinx) and uterus consistent with expected normal function with no congenital
structural abnormality at screening or within 1 year prior to randomization.
Note: This also includes females who have been diagnosed with any of the medical conditions
related to uterus (e. g, fibroids) but have had them surgically corrected prior to randomization.
8) r-hFSH naïve participant who are appropriate to undergo ART procedure should be first cycle of
present series.
9) Negative serum pregnancy test at screening and on the day 1 of stimulation with gonadotropins
prior to administration of gonadotropin as well non-lactating for controlled ovarian stimulation.
10) Total testosterone, prolactin, and thyroid stimulating hormone (TSH) within the normal limits
for the clinical laboratory or considered not clinically significant by the Investigator at screening or within 12 months prior to screening.
Participants are eligible for COS cycle 2 only if all of the following criteria apply:
11) Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous COS
cycle 1 (fresh cycle).
12) Failure to achieve ongoing pregnancy and early pregnancy loss in the previous COS cycle 1.
ExclusionCriteria
Details
1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components excipients thereof (refer to the SmPC)2, or drug or other allergy that, in the
opinion of the investigator, contraindicates participation in the study.
2) Documented medical history of uncontrolled, clinically significant intercurrent cardiac,
vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic,
psychiatric, or metabolic disturbances or any other medical condition for which, in the
opinion of the investigator, participation would not be in the best interest of the participant
(e.g., compromise the well-being) or that could prevent, limit, or confound the protocolspecified
assessments.
3) Contraindications to the use of investigational intervention per SmPC of Gonal-f.
4) Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first
dose of investigational intervention.
5) Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior
resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is
obtained.
6) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV
antibody test at screening.
7) History of abuse of alcohol, nicotine containing products or drugs.
8) History of recurrent miscarriages (3 or more consecutive miscarriages) within 1 year before
screening.
9) Documented evidence of Severe ovarian hyperstimulation syndrome (OHSS) in a previous
ART treatment.
10) Treatment with biologic agents (such as monoclonal antibodies including marketed drugs)
within 3 months or 5 half-lives (whichever is longer) prior to Baseline.
11) Previous IVF or ART failure due to a poor response to gonadotropins (greater than 20 days of
gonadotropin stimulation). (Poor response is defined as development of less than or equal to 3 oocytes or history
of 2 previous cycle cancellations prior to oocyte retrieval due to poor response).
12) History or current evidence of tumors of ovary, breast, uterus, adrenal glands, pituitary or
hypothalamus or any other malignant neoplasm such as endometriosis stage III-IV.
13) Any hormonal treatment within 1 month before the start of the r-hFSH treatment (except stable
participants who are on thyroid hormone).
14) Taken any disallowed therapies as noted in Section 6.9, before the planned first dose of
investigational intervention.
15) Received an investigational intervention or used an invasive investigational medical device
within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
16) History of randomization in the current study for r-FSH administration.
17) Participant or his partner has a known genetic abnormality and/or require pre-implantation
genetic diagnosis which makes participant unfit for the trial as determined by investigator.
18) Participant is ovum donor.
19) Presence of clinically significant polycystic ovarian syndrome (PCOS) according to
Rotterdam criteria 20033 as determined by investigator.
20) Known abnormal cervical cytology of clinical significance observed within three years prior
to randomization (unless the clinical significance has been resolved).
21) Known currently active pelvic inflammatory disease.
Participants meeting any of the criteria listed below will not be eligible for COS cycle 2:
22) Non-compliance to protocol compliance in the previous cycle which impact overall safety of
the participants and study assessments.
23) Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit
in the previous COS cycle 1.
24) Use of any investigational medicinal product since the end-of-trial end-of-cycle visit in the
previous COS cycle 1.
25) One or more follicles greater than or equal to 10 mm observed on the transvaginal ultrasound prior to start of dosing
on stimulation day 1 (COS cycle 2).
26) Pregnancy (negative urinary pregnancy test must be documented prior to start of dosing on
stimulation day 1 of COS cycle 2).
27) Severe OHSS in a previous COS cycle 1.
28) Any clinically relevant change to any of the eligibility criteria in the previous COS cycle 1.
29) In case of late pregnancy loss and thus failure to achieve live birth in the COS cycle 1.
Method of Generating Random Sequence
Random Number Table
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To establish the therapeutic
equivalence of r-hFSH-test
compared with r-hFSHreference
in the fresh cycle in
women undergoing controlled
ovarian stimulation for ART
Day 2 to 5 up to 20
Secondary Outcome
Outcome
TimePoints
To compare the
pharmacodynamic effects and
to characterize additional
efficacy parameters of r-hFSHtest
with r-hFSH-reference in
the fresh cycle in women
undergoing controlled ovarian
stimulation for ART
1) Number of follicles (less than or equal to 10 mm, greater than 10 to 14 mm, greater than 14 to 17 mm, greater than 17 mm) on stimulation Day 6 prior to dose adaptation
2) Number of follicles greater than 14 mm post-trigger medication
injection
3) Number of participants with less than 4, 4-7, 8-14, 15-19, 20-24 and
greater than or equal to 25 oocytes retrieved on day 6 and on the day of ovulation
induction
4) Cycle cancellation due to over and under stimulation
5) Endocrine profile:Serum FSH at screening, baseline, on stimulation day 6, end-of-stimulation and at oocyte retrieval and Luteinizing hormone (LH), inhibin-B, Estradiol (E2) and progesterone (P4) at screening, at baseline, on stimulation day 6 and end-of-stimulation.
6) Total dose of r-hFSH required in IU
7) Number of days of r-hFSH stimulation
8) Number of participants needing dose adaptation (decrease or increase in dose of r-hFSH)
9) Fertilisation rate defined as proportion of the number of
fertilized (2 pronuclei [2PN]) oocytes at 19±2 hours after
insemination to the number of oocytes retrieved
10) Number and quality of embryos on day 3 and blastocysts on
day 5 after oocyte retrieval
11) Endometrial thickness (mm) on Stimulation Day 6 prior to
dose adaptation and on the HCG administration day
To compare the pregnancy
related outcomes of r-hFSHtest
with r-hFSH-reference in
the fresh cycle in women
undergoing controlled ovarian
stimulation for ART
1) Ongoing pregnancy rate at least 10 weeks after the embryo
transfer (Defined as at least one intrauterine viable fetus 10
weeks after the embryo transfer expressed per 100 initiated
cycles, aspiration cycles, or embryo transfer cycles)
2) Fertilisation rate
3) Clinical and ongoing pregnancy rate (per randomized
participant, per oocyte retrieval, and per embryo transfer)
4) Ectopic pregnancy rate
5) Take-home baby rate
6) Number of cryopreserved 2PN stages, embryos blastocysts
7) Number of transferred embryos
8) Number of participants with cycle cancellation
9) Number of non-responders
10) Implantation rate
11) Positive BhCG rate
12) Clinical pregnancy rate (per 100 initiated, per aspirated and per embryo transfer cycles).
Complications during pregnancy, delivery, neonatal
outcome including congenital malformations including
ectopic pregnancy and multiple pregnancy
13) Initial clinical pregnancy rates
14) Ongoing pregnancy rates
15) Number of metaphase –II oocytes
16) Number percentage of fertilized oocytes
Target Sample Size
Total Sample Size="320" Sample Size from India="320" 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)
26/07/2025
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="0" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
To establish the therapeutic equivalence and compare the pharmacodynamic effects and to characterize additional efficacy parameters of r hFSH-test compared with r hFSH reference in the fresh cycle in women undergoing controlled ovarian stimulation for ART.