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).

LG Chem

Status and phase: Enrolling; Phase 4

Conditions: Female Infertility

Treatments: Drug: Fang Le Shu (Follitrope); Drug: Guo Na Fen (Gonal-F)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06921395

LG-FSCL006

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Fang Le Shu

Experimental group

Description:

Fang Le Shu

Treatment:

Drug: Fang Le Shu (Follitrope)

Guo Na Fen

Active Comparator group

Description:

Guo Na Fen

Treatment:

Drug: Guo Na Fen (Gonal-F)