Status:
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).
Lead Sponsor:
LG Chem
Conditions:
Female Infertility
Eligibility:
FEMALE
20-39 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT06921395
Start Date
February 15 2025
End Date
June 30 2026
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of Zhengzhou University
Zhengzhou, China