Female Infertility
Conditions
Brief summary
The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
Interventions
DRUGFang Le Shu (Follitrope)
rFSH 150 IU, 225 IU, 300 IU per syringe
DRUGGuo Na Fen (Gonal-F)
rFSH 450 IU per pen
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Is pre-menopausal female aged ≥20 to \<40 years. * Has regular menstrual cycles of ≥25 to ≤35 days. * Has Normal baseline serum FSH, LH, E2, P4. * Is able to voluntarily sign the informed consent form (ICF). * Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.
Exclusion criteria
* Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease. * Has body mass index (BMI) of \>30 kg/m2. * Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization * Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll). * Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher. * Poor ovarian reponder according to Bologna criteria * Has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(PGT) * Has history of three or more failures in previous IVF cycles * Has history of recurrent miscarriage * Has known current active pelvic inflammatory disease. * Is currently breastfeeding. * Has a contraindication to pregnancy that would preclude participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved | 36 ± 3 hours after HGC trigger |
Secondary
| Measure | Time frame |
|---|---|
| High quality embryo rate | 3 days after oocyte retrieval |
| Biochemical pregnancy rate | 14 days after embryo transfer |
| Clinical pregnancy rate | 5 weeks after embryo transfer |
| Ongoing pregnancy rate | 10 weeks after embryo transfer |
| Miscarriage rate | 28 weeks of gestation |
| Live birth rate | 40 weeks of gestation |
Countries
China
Outcome results
None listed