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).

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Female Infertility
• Intervention / Treatment: Drug: Fang Le Shu (Follitrope); Drug: Guo Na Fen (Gonal-F)

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Study Lead; Phone Number: +82-2-6987-4147; Email: lgclinical@lgchem.com

Study Locations

• China
  • Zhengzhou, China
    • Recruiting
    • the First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fang Le Shu	Drug: Fang Le Shu (Follitrope); rFSH 150 IU, 225 IU, 300 IU per syringe
Active Comparator: Guo Na Fen	Drug: Guo Na Fen (Gonal-F); rFSH 450 IU per pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of oocytes retrieved	36 ± 3 hours after HGC trigger

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical pregnancy rate	5 weeks after embryo transfer
High quality embryo rate	3 days after oocyte retrieval
Biochemical pregnancy rate	14 days after embryo transfer
Ongoing pregnancy rate	10 weeks after embryo transfer
Miscarriage rate	28 weeks of gestation
Live birth rate	40 weeks of gestation

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: LG-FSCL006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No