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).

Launched by LG CHEM · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two medications, Fang Le Shu and Guo Na Fen, to see which one is more effective and safer for helping women with infertility during a process called in vitro fertilization (IVF). IVF is a method that helps people become pregnant by combining eggs and sperm outside the body and then placing the embryos back into the woman’s uterus. The trial is currently recruiting women aged 20 to 39 who have been trying to get pregnant for at least a year and have regular menstrual cycles.

To participate, women must have normal hormone levels and be in good health, meaning they should not have serious health issues or certain medical conditions that could affect their fertility. Participants will receive one of the two medications, and their progress will be monitored. This study is an important step in finding the best options for women undergoing IVF, and it aims to provide valuable information that could help improve fertility treatments in the future.

Gender

FEMALE

Eligibility criteria

• 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.