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

A Multicenter, Double-blind, Non-inferiority, Phase 3 RCT Comparing GenSci094 and Recombinant FSH During the First Seven Days of Ovarian Stimulation in Chinese ART Patients

To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.

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.