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).
NCT ID: NCT06921395
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
248 participants
INTERVENTIONAL
2025-02-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fang Le Shu
Fang Le Shu
Fang Le Shu (Follitrope)
rFSH 150 IU, 225 IU, 300 IU per syringe
Guo Na Fen
Guo Na Fen
Guo Na Fen (Gonal-F)
rFSH 450 IU per pen
Interventions
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Fang Le Shu (Follitrope)
rFSH 150 IU, 225 IU, 300 IU per syringe
Guo Na Fen (Gonal-F)
rFSH 450 IU per pen
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
39 Years
FEMALE
No
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Locations
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The first affiliated hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Other Identifiers
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LG-FSCL006
Identifier Type: -
Identifier Source: org_study_id
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