Recombinant Follicle-stimulating Hormone in Treatment for Infertility

Inclusion Criteria: * Subject has indication ART using COS. * Subject has regular menstrual cycle of 21-35 days. * Subject has one of the following: 1. FSH level \<10 IU/L and Estradiol levl \<80 pg/mL at day 2 or 3 2. Anti-mullerian hormone (AMH) level between 1 to 3.5 ng/mL during the menstrual cycle * 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: 1. Any agent(s) known to affect ovulation (e.g., neuroleptics); 2. Drugs known or suspected to be teratogenic in nature.