Infertility
Conditions
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.
Interventions
DRUGGenSci094
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.
DRUGPlacebo RecFSH / follitropin alfa
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.
BIOLOGICALBiological: RecFSH / Follitropin alfa (Days 1 to 7)
Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
DRUGPlacebo GenSci094
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.
BIOLOGICALRecFSH / Follitropin alfa (Days 8 to hCG)
From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.
DRUGGanirelix
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
BIOLOGICALhCG
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
DRUGProgesterone
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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Oocytes Retrieved | Approximately Day 10-14 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Fertilized Oocytes (Fertilization Rate) | Up to 18 hours after start of fertilization |
| Number of Embryos Obtained on Day 3 Categorized by Quality | Post fertilization Day 3 |
| Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | Assessed at least 10 weeks after embryo transfer |
| Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer | Two weeks after embryo transfe |
| Percentage of Participants With a early miscarriage（early miscarriage rate）Per Clinical Pregnancy | Up to 12 weeks after embryo transfer |
| Percentage of Gestational Sacs (Implantation Rate) | Up to 6 weeks after embryo transfer |
Countries
China
Outcome results
None listed