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).

NCT06921395 | Recruiting Phase 4

• 1 other identifier: LG-FSCL006
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  36 ± 3 hours after HGC trigger

Secondary Outcomes (6)

• 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

• Ongoing pregnancy rate

  10 weeks after embryo transfer

• Miscarriage rate

  28 weeks of gestation

Study Arms (2)

Fang Le Shu

EXPERIMENTAL

Fang Le Shu

Drug: Fang Le Shu (Follitrope)

Guo Na Fen

ACTIVE COMPARATOR

Guo Na Fen

Drug: Guo Na Fen (Gonal-F)

Interventions

Fang Le Shu (Follitrope) DRUG

rFSH 150 IU, 225 IU, 300 IU per syringe

Fang Le Shu

Guo Na Fen (Gonal-F) DRUG

rFSH 450 IU per pen

Guo Na Fen

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Clinical Study Lead

CONTACT

+82-2-6987-4147; lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 10, 2025
• Study Start: February 15, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)