Clinical trial NCT06921395: 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).
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Female Infertility
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 248
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: 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.


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.

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 36 ± 3 hours after HGC trigger
Secondary outcomes:
measure: High quality embryo rate
timeFrame: 3 days after oocyte retrieval
measure: Biochemical pregnancy rate
timeFrame: 14 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 10 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 28 weeks of gestation
measure: Live birth rate
timeFrame: 40 weeks of gestation
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
Study officials:
References: