Triggering Ovulation at Follicle Size Smaller or Larger Than 17mm in a Modified Natural Cycle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
The rise in frozen embryo transfer (FET) cycles within assisted reproductive technology (ART) has sparked the need to refine endometrial preparation protocols. The switch from hormone replacement cycles (HRT) to natural cycles, poses scheduling challenges onto laboratories, doctors and patients. The modified natural cycle (mNC), offering more precision for scheduling, shows promise but lacks comprehensive data on the potential flexibility of triggering criteria that may allow to control timing in a wider range.
This prospective randomized study seeks to address this knowledge gap by evaluating the non-inferiority of triggering ovulation in mNC with follicle diameters of 13-16.9mm compared to the conventional 17-22mm.
The study aims to enhance the understanding of the impact of follicle size at ovulation in reproductive outcomes, optimize FET treatments providing a more flexible mNC protocol, and improve patient care in ART clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least one expanded blastocyst (regardless of its quality)
- •Spontaneous menstrual cycles
- •Consent to undergo frozen embryo transfer in a modified natural cycle
排除标准
- •Abnormal uterine cavity
- •Fluid in endometrial cavity
研究组 & 干预措施
Control
Trigger indicated as per standard clinical practice at folicular diameter of at least 17mm
Early trigger
Trigger indicated at folicular diameter smaller than standard clinical practice
干预措施: Trigger at smaller folicular size (Procedure)
结局指标
主要结局
Pregnancy rate
时间窗: From embryo transfer up to 2 weeks later
Rate of positive pregnancies over total transfers performed, according to beta-test result
次要结局
- Implantation rate(up to 8 weeks of gestational age)
- Cancelation rate(Perioperative/Periprocedural)
- Miscarriage rate(From embryo transfer to delivery, up to 40 weeks)