NCT07457684已完成不适用
Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin (the BONANZA Study)
Clinique Ovo1 个研究点 分布在 1 个国家目标入组 846 人开始时间: 2025年12月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 846
- 试验地点
- 1
- 主要终点
- Number of utilizable blastocysts per treatment cycle
研究概览
简要总结
The goal of this retrospective study is to compare the effectiveness and cost-effectiveness of two mixed ovarian stimulation protocols in women undergoing in vitro fertilization (IVF).
The main questions it aims to answer are:
- Does the combination of follitropin delta + HP-hMG result in a higher number of utilizable blastocysts per treatment cycle compared to follitropin alfa + HP-hMG?
- Does the follitropin delta based mixed protocol reduce total gonadotropin dose and cost per usable blastocyst while maintaining or improving pregnancy outcomes?
Researchers will compare follitropin alfa (Gonal-F®) + HP-hMG (Menopur®) with follitropin delta (Rekovelle®) + HP-hMG (Menopur®) to determine which protocol improves ovarian response, embryology outcomes, pregnancy rates, and overall treatment cost-efficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18-45 years included
- •First ovarian stimulation cycle only
- •Patients who used mixed protocols combining menotropin and follitropin alfa or delta
- •Patients whose Rekovelle doses were prescribed using the algorithm based on AMH and weight.
排除标准
- •Patients who did not follow the algorithm to determine follitropin delta dosing and who required dose adjustments during the stimulation
- •Patients who took concomitant treatment, such as corticosteroids, low molecular weight heparin, nonsteroidal anti-inflammatory drugs, recombinant LH or intra-vaginal vasodilators
- •Oocytes donation or fertility preservation cycles
研究组 & 干预措施
Follitropin delta (Rekovelle®) + HP-hMG (Menopur®)
Follitropin alfa (Gonal-F®) + HP-hMG (Menopur®)
结局指标
主要结局
Number of utilizable blastocysts per treatment cycle
时间窗: For IVF performed from January 2018 to December 2024
次要结局
- Number of retrieved oocytes(For IVF performed from January 2018 to December 2024)
- Number of mature oocytes (MII)(For IVF performed from January 2018 to December 2024)
- Number of stimulation days(For IVF performed from January 2018 to December 2024)
- Totals doses of rFSH, HP-hMG, and FSH(For IVF performed from January 2018 to December 2024)
- Costs of rFSH, HP-hMG, and FSH(For IVF performed from January 2018 to December 2024)
- Number of fertilized oocytes (2PN)(For IVF performed from January 2018 to December 2024)
- Total FSH/ usable blastocysts ratio(For IVF performed from January 2018 to December 2024)
- Pregnancy rates(For IVF performed from January 2018 to December 2024)
- Cost per blastocyst(For IVF performed from January 2018 to December 2024)
研究者
研究点 (1)
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