Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fang Le Shu (Follitrope), Guo Na Fen (Gonal-F).
- Who it may be relevant to
- Registry conditions: Female Infertility. Basic parameters: 20 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.
Overview
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
- Drug Fang Le Shu (Follitrope)
rFSH 150 IU, 225 IU, 300 IU per syringe - Drug Guo Na Fen (Gonal-F)
rFSH 450 IU per pen
Primary outcome measures
- Number of oocytes retrieved [Time frame: 36 ± 3 hours after HGC trigger]
Secondary outcome measures (6)
- High quality embryo rate [Time frame: 3 days after oocyte retrieval]
- Biochemical pregnancy rate [Time frame: 14 days after embryo transfer]
- Clinical pregnancy rate [Time frame: 5 weeks after embryo transfer]
- Ongoing pregnancy rate [Time frame: 10 weeks after embryo transfer]
- Miscarriage rate [Time frame: 28 weeks of gestation]
- Live birth rate [Time frame: 40 weeks of gestation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The first affiliated hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT06921395 · LG-FSCL006