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).

Phase 4

Recruiting

• Conditions: Female Infertility
• Interventions: Drug: Fang Le Shu (Follitrope); Drug: Guo Na Fen (Gonal-F)

• Registration Number: NCT06921395
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-15
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fang Le Shu	Fang Le Shu (Follitrope)	Fang Le Shu
Guo Na Fen	Guo Na Fen (Gonal-F)	Guo Na Fen

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	36 ± 3 hours after HGC trigger

Secondary Outcome Measures

Name	Time	Method
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
Miscarriage rate	28 weeks of gestation
Ongoing pregnancy rate	10 weeks after embryo transfer
Live birth rate	40 weeks of gestation

Trial Locations

Locations (1)

The first affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China