Status and phase
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About
This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). The participant will receive r-hFSH, fixed-dose for 5 days, and day 6 onwards the dose may be adjusted for a single cycle of COS followed by ART procedures, and post-ART follow-up for ongoing pregnancy.
The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Subject has indication ART using COS.
Subject has regular menstrual cycle of 21-35 days.
Subject has one of the following:
Subject has an antral follicle count (AFC) of 10- 25, follicle ≤10 mm in diameter before ovarian stimulation
Subject has a BMI ≥18 and <30 kg/m2
Subject has results of clinical laboratory tests within normal reference range
Subject and her partner are willing to provide written informed consent and comply
Exclusion Criteria Details Subject has history of >2 failed ART cycles
Subject with history of any endocrine abnormality, with documented hormone levels outside the reference range, which are clinically relevant, at screening
Subject with a history of ovarian hyper-response (i.e., previous COS cycle with >25 follicles of ≥11 mm in diameter on USG) or OHSS
Subject with documented polycystic ovarian syndrome (PCOS) at the time of screening
Subject with only one ovary or ovarian abnormality (including endometrioma >10 mm; visible on USG), at screening
Subject with documented severe endometriosis (American Society of Reproductive Medicine stage 3 or stage 4) or hydrosalpinx, at screening
Subject with submucosal fibroids ≥5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation, at screening
Subject with a history of extrauterine pregnancy within 3 months of screening
Subject with history of poor response to gonadotropin treatment (retrieval of <4 oocytes) in the previous ART cycle
Subject with history of ≥3 miscarriages, at any time prior to screening
Subject who has tested positive for Human Immunodeficiency Virus, Hepatitis B or Hepatitis C at screening
Subject known to be allergic, hypersensitive, or intolerant to any of the preparations of r hFSH or its excipients, that will be used in the study
Subject with contraindications to the use of gonadotropins (e.g., tumours, undiagnosed vaginal bleeding, or ovarian cysts) or gonadotropin-releasing hormone (GnRH) antagonists
Subject with a history of epilepsy, thrombophilia, cardiovascular, gastrointestinal, hepatic, renal, pulmonary, auto-immune disease, or any active infection, requiring treatment which at the investigator's discretion might interfere with the study
Subject with history of malignancy
Subject who smokes or has stopped smoking within the last 3 months prior to screening
Subject with history of alcohol or drug abuse within 12 months prior to screening
Subject who has received any treatment listed below within 5 half-lives prior to screening:
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups
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Central trial contact
Anirban Roy Chowdhury VP CR & PV Bharat serums and vaccines ltd; Prashant Mehrotra
Data sourced from clinicaltrials.gov
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