NCT06921395 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).
| NCT ID | NCT06921395 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | LG Chem |
| Condition | Female Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 248 participants in total. It began in 2025-02-15 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06921395 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 39 Years, studying Female Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06921395 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06921395 currently recruiting?
Yes, NCT06921395 is actively recruiting participants. Contact the research team at lgclinical@lgchem.com for enrollment information.
Where is the NCT06921395 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06921395 clinical trial?
NCT06921395 is sponsored by LG Chem. The trial plans to enroll 248 participants.