To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (ANGAS)

Inclusion Criteria: Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); >=20 and <40 years of age at the time of signing informed consent; Body weight >=50 kg and body mass index (BMI) >=18 and <=28 kg/m^2; AMH<4.0 and>=1.1μg/L FSH<10 IU/L Willing and able to sign informed consent. Exclusion Criteria: History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS); History of/or current polycystic ovary syndrome (PCOS); More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-4); Presence of unilateral or bilateral hydrosalphinx (visible on USS); Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >4 cm; More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable); History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment; History of recurrent miscarriage (3 or more, even when unexplained); Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase; Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease; Use of hormonal preparations within 1 month prior to randomization; Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol; Administration of investigational drugs within three months prior to signing informed consent.