DRUG
GenSci094
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
Status
Completed
Phase
Phase 3
Enrollment
176
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.
DRUG
powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
BIOLOGICAL
Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
DRUG
Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
BIOLOGICAL
From Stimulation Day 8 onwards a daily SC dose 75IU~300 IU recFSH was administered up to and including the Day of hCG.
DRUG
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
BIOLOGICAL
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
DRUG
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.
Timeline
First posted
Oct 19, 2023
Study start
Mar 24, 2023
Primary completion
Dec 25, 2023
Study completion
Jan 29, 2024
Results posted
Not reported
Registry updated
Dec 3, 2024
Outcomes
Mean Number of Oocytes Retrieved
Time frame · Approximately Day 10-14
Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
Time frame · Assessed at least 10 weeks after embryo transfer
Percentage of Fertilized Oocytes (Fertilization Rate)
Time frame · Up to 18 hours after start of fertilization
Number of Embryos Obtained on Day 3 Categorized by Quality
Time frame · Post fertilization Day 3
Percentage of Gestational Sacs (Implantation Rate)
Time frame · Up to 6 weeks after embryo transfer
Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer
Time frame · Two weeks after embryo transfe
Percentage of Participants With a early miscarriage(early miscarriage rate)Per Clinical Pregnancy
Time frame · Up to 12 weeks after embryo transfer
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital
Guangzhou, Guangdong, China
Publications
No PMID-linked publications were present in this registry snapshot.
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