Clinical trial NCT06091436: To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
First posted: 2023-10-19
Enrollment: 176
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.


Eligibility 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.

Primary outcomes:
measure: Mean Number of Oocytes Retrieved
timeFrame: Approximately Day 10-14
Secondary outcomes:
measure: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
timeFrame: Assessed at least 10 weeks after embryo transfer
measure: Percentage of Fertilized Oocytes (Fertilization Rate)
timeFrame: Up to 18 hours after start of fertilization
measure: Number of Embryos Obtained on Day 3 Categorized by Quality
timeFrame: Post fertilization Day 3
measure: Percentage of Gestational Sacs (Implantation Rate)
timeFrame: Up to 6 weeks after embryo transfer
measure: Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer
timeFrame: Two weeks after embryo transfe
measure: Percentage of Participants With a early miscarriage（early miscarriage rate）Per Clinical Pregnancy
timeFrame: Up to 12 weeks after embryo transfer
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
name: xiaoyan liang, doctor
role: STUDY_CHAIR
References: