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

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Collaborator: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Follicle Stimulating Hormone; Ganirelix; Progesterone

Criteria

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.