Status:
COMPLETED
To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Infertility
Eligibility:
FEMALE
20-39 years
Phase:
PHASE3
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT06091436
Start Date
March 24 2023
End Date
January 29 2024
Last Update
December 3 2024
Active Locations (1)
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1
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
Guangzhou, Guangdong, China, 510610