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).

Recruiting now · Phase 4

Conditions studied: Female Infertility

In brief

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.

Key facts

Study ID: NCT06921395
Run by: LG Chem
People needed: 248
Starts: 2025-02-15
Expected to finish: 2026-06-30
Last updated by the study team: 2025-04-10

Who can join

Age: 20 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

The first affiliated hospital of Zhengzhou University — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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