Follitrope (recombinant human follicle stimulating hormone) / LG Chem - LARVOL DELTA

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). (clinicaltrials.gov) - P4 | N=248 | Active, not recruiting | Sponsor: LG Chem | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2026 ➔ Oct 2026

Enrollment closed • Trial completion date • Gynecology • Infertility • Sexual Disorders

FSH-PPOS: 225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women (clinicaltrials.gov) - P=N/A | N=380 | Not yet recruiting | Sponsor: Vietnam Military Medical University

New trial • Infertility • Sexual Disorders

COST-CONSEQUENCE MODEL COMPARING ORIGINATOR R-HFSH-ALFA TO OTHER R-FSH-ALFA OPTIONS IN UP TO THREE COMPLETE OVARIAN STIMULATION CYCLES IN ASSISTED REPRODUCTIVE TECHNOLOGY IN CHINA (ISPOR 2026) - "OBJECTIVES: This study aims to compare the clinical and economic outcomes of originator recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa [O]) versus other r-FSH-alfa products: A (recombinant human follitropin for injection [Jinsaiheng®]), B (recombinant human follitropin for injection [Anxinbao®]), and C (recombinant human follitropin prefilled syringe [Follitrope®]) during assisted reproductive technology (ART) across up to three complete ovarian stimulation (OS) cycles. A decision-tree model was developed in Microsoft Excel to simulate treatment pathways for women with infertility undergoing ART using O/alternative products... The originator r-hFSH-alfa demonstrated higher CLBR and lower cost/CLB, saving costs between ¥7,000-12,000/LB, while shortening TTLB by approximately 1.5-2 months, making it a cost-effective option for ART."

Infertility • Sexual Disorders

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). (clinicaltrials.gov) - P4 | N=248 | Recruiting | Sponsor: LG Chem

New P4 trial • Gynecology • Infertility • Sexual Disorders

EFFECTIVENESS AND SAFETY OF RECOMBINANT HUMAN FOLLICLE-STIMULATING HORMONE (RHFSH) IN INFERTILE WOMEN UNDERGOING ASSISTED REPRODUCTIVE TECHNOLOGY (ART): A KOREAN NATIONWIDE RETROSPECTIVE COHORT STUDY (ASRM 2024) - "Outcome variables comprised the effectiveness (proportion of ≥ 11 oocytes retrieved, pregnancy rate, live birth rate) and safety (ectopic pregnancy, miscarriage, preterm birth, ovarian hyperstimulation syndrome [OHSS]) in whole rhFSH group, included Follitrope™ and other rhFSH group...IMPACT STATEMENT This study's significance lies in being the first to investigate the effectiveness, including the live birth rate, and safety with rhFSH in a real ART setting, using nationwide data. This study might help guide clinicians and patients in decision-making regarding the use of rhFSH for ART."

Retrospective data • Gynecology • Infertility

FOLLITROPIN DELTA VERSUS CONVENTIONAL STIMULATION IN POOR OVARIAN RESERVE PATIENTS: A RETROSPECTIVE ANALYSIS (ASPIRE 2024) - "Methods Retrospective analysis of 120 GnRH antagonist cycles (Rekovelle 12 mcg/day, 55 cycles; Follitrope 300 IU/day, 65 cycles) from April 2023 to October 2023. Conclusions Although conventional FSH yielded more oocytes, follitropin delta achieved similar embryology outcomes. Further RCTs and larger studies are required."

Retrospective data

Effectiveness and Safety of Recombinant Human Follicle-Stimulating Hormone (Follitrope™) in Inducing Controlled Ovarian Stimulation in Infertile Women in Real-World Practice: a Prospective Cohort Study. (PubMed, Reprod Sci) - "In real-world practice, rhFSH (Follitrope™) is safe and effective in inducing ovarian stimulation in infertile women. Patient characteristics identified as predictors can be considered to be highly related to optimal clinical outcomes."

Journal • Real-world • Real-world evidence • Gynecology • Infertility

Comparative Assessment of the Structural Features of Originator Recombinant Human Follitropin Alfa Versus Recombinant Human Follitropin Alfa Biosimilar Preparations Approved in Non-European Regions. (PubMed, Int J Mol Sci) - "In the present study, we compared the structural features of reference r-hFSH-alfa with those of five biosimilar preparations approved in different global regions outside Europe (Primapur, Jin Sai Heng, Follitrope, Folisurge, and Corneumon) with respect to glycosylation, macro- and microheterogeneity, and other post-translational modifications and higher order structure...Minor differences in oxidation levels were seen among the different products. Therefore, in summary, we identified var ious differences in N-glycosylation occupancy, antennarity, sialylation and oxidation between reference r-hFSH-alfa and the biosimilar preparations analyzed."

Journal

MSP-IVC: Minimal Stimulation Protocol Using Aromek(Letrozole) and Follitrope(recFSH) Combined With INVOCell-Low Cost IVF (clinicaltrials.gov) - P=N/A; N=30; Recruiting; Sponsor: Galaxy Pharma (Pvt) Limited; N=100 ➔ 30; Trial completion date: Feb 2012 ➔ Mar 2022; Trial primary completion date: Dec 2011 ➔ Dec 2021

Clinical • Enrollment change • Review • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

Observational Study to Develop Dosing Chart (clinicaltrials.gov) - P=N/A; N=534; Completed; Sponsor: LG Chem; Recruiting ➔ Completed; N=1000 ➔ 534; Trial completion date: Nov 2020 ➔ Jul 2020; Trial primary completion date: Nov 2020 ➔ Jul 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infertility • Long-acting Reversible Contraceptives • Sexual Disorders

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer. (PubMed, Aging (Albany NY)) - "No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope Prefilled Syringe is safe and efficacious for ovarian stimulation."

Journal

Observational Study to Develop Dosing Chart (clinicaltrials.gov) - P; N=1000; Recruiting; Sponsor: LG Chem

Clinical • New trial