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Active, not recruiting Phase 4

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 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 4
Started
2025-02-15
Last updated
2026-09-02

Condition(s) studied

Female Infertility

Investigational drug(s) / intervention(s)

Fang Le Shu (Follitrope)Guo Na Fen (Gonal-F) →

Fang Le Shu (Follitrope): rFSH 150 IU, 225 IU, 300 IU per syringe

Guo Na Fen (Gonal-F): rFSH 450 IU per pen

Study 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

Sex
FEMALE
Min age
20 Years
Max age
39 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of oocytes retrieved — 36 ± 3 hours after HGC trigger

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of Zhengzhou University Zhengzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921395 on ClinicalTrials.gov ↗ ← All trials in China