Retrospective Study of High Dose Follitropin Delta in a Mixed Protocol With Human Chorionic Gonadotropin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Number of good quality blastocysts
研究概览
简要总结
Follitropin delta is a rFSH, uniquely expressed in a human fetal retinal cell line, which owing to differences in glycosylation profile has a lower clearance and induces a higher ovarian response in humans than existing rFSH preparations when administered at equal doses of biological activity. A noninferiority clinical trial (ESTHER-1) in which individualized dosage of follitropin delta according to each patient's profile (AMH and weight) was compared to conventional follitropin alfa dosing for IVF have demonstrated that an individualized follitropin delta dosing is noninferior to conventional follitropin alfa with respect to ongoing pregnancy rate, ongoing implantation rate, and also live births, with a concomitant reduction in iatrogenic complications, including OHSS
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 to 42 years of age undergoing IVF/ICSI cycle
- •IVF antagonist protocol
- •Regular menstrual cycles of 24-35 days
- •Presence of both ovaries
排除标准
- •Endometriosis stage III/IV
- •History of recurrent miscarriages, defined as ≥ 3 consecutive losses
- •Women undergoing ovarian stimulation for oncologic or elective fertility preservation
- •Women participating in any other research project
- •Hypersensitivity to follitropin delta and/or human chorionic gonadotropin
- •Use of Growth Hormone (GH) during the stimulation cycle
研究组 & 干预措施
Follitropin delta + hCG
Combination of follitropin delta and serial hCG injections at individualized doses, where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle
干预措施: Follitropin delta (Drug)
Follitropin delta + HP-hMG
Combination of follitropin delta and highly-purified human menopausal gonadotropin (HP-hMG) where dosing regimen was determined according to AMH and weight in women undergoing an IVF antagonist cycle
干预措施: Follitropin delta (Drug)
结局指标
主要结局
Number of good quality blastocysts
时间窗: Up to 6 day
Number of good quality oocytes fertilized
次要结局
未报告次要终点