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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). | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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.

NCT06921395•LG Chem

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 39 years

Sex

FEMALE

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.
+2 more criteria

Locations (1)

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

Key Dates

Start Date

February 15, 2025

Primary Completion Date

September 30, 2025

Completion Date

June 30, 2026

Last Updated

April 10, 2025

Enrollment

248

ESTIMATED participants

Conditions

Female Infertility

Interventions

Fang Le Shu (Follitrope)

DRUG

Guo Na Fen (Gonal-F)

DRUG

Contacts

Clinical Study Lead

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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).

Inclusion Criteria

Exclusion Criteria

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