Comparing two medications for ovarian stimulation in women undergoing IVF.

A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.

This study is testing two different medications to see which one helps women undergoing IVF get better results and have fewer side effects.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 20 Years to 39 Years
• Sex: Female
• Sponsor: LG Chem (Industry-sponsored)
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT06921395 on ClinicalTrials.gov

What this trial studies

This phase IV clinical trial aims to evaluate the efficacy and safety of two medications, Fang Le Shu and Guo Na Fen, for controlled ovarian stimulation in women experiencing infertility who are undergoing In Vitro Fertilization-Embryo Transfer (IVF-ET). The study is randomized, open-label, and involves multiple centers, allowing for a diverse patient population. Participants will be monitored for their response to the treatments and any associated side effects. The goal is to determine which medication is more effective in facilitating successful IVF outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are pre-menopausal women aged 20 to 39 with regular menstrual cycles and a history of infertility.

Not a fit: Patients with significant systemic diseases, high BMI, or certain reproductive health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the success rates of IVF treatments for women struggling with infertility.

How similar studies have performed: Other studies have explored similar approaches in ovarian stimulation, but the specific comparison of these two medications in this context is less common.

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.

Where this trial is running

Zhengzhou

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

Study contacts

• Study coordinator: Clinical Study Lead

Conditions Female Infertility