Actively Recruiting
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).
Led by LG Chem · Updated on 2025-04-10
248
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-menopausal female aged 20 to less than 40 years
- Regular menstrual cycles of 25 to 35 days
- Normal baseline serum FSH, LH, E2, and P4 levels
- Able to voluntarily sign the informed consent form
- History of infertility for at least 1 year or confirmed infertility diagnosis
You will not qualify if you...
- Known major systemic disease or endocrine/metabolic abnormalities except controlled thyroid disease
- Body mass index over 30 kg/m2
- Significant abnormalities of uterus, ovary, or appendix prior to randomization
- History of surgeries affecting oocyte retrieval or pregnancy outcome except polypectomy
- History of severe ovarian hyperstimulation syndrome (Grade 4 or higher)
- Poor ovarian responder according to Bologna criteria
- Plans to donate oocytes, receive embryo from another woman, or undergo preimplantation genetic testing
- History of three or more IVF cycle failures
- History of recurrent miscarriage
- Current active pelvic inflammatory disease
- Currently breastfeeding
- Contraindication to pregnancy preventing trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
C
Clinical Study Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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