Endometrial Injury Prior Ovulation Induction for Assisted Reproductive Techniques: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Live Birth
研究概览
简要总结
The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who will start assisted reproductive techniques with planned fresh embryo transfer.
- •Age between 18 and 38 years.
- •Written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Control group
Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
干预措施: Control group (Procedure)
Endometrial injury group
Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
干预措施: Endometrial injury (Procedure)
结局指标
主要结局
Live Birth
时间窗: 1 year
The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. Note: All allocated women will be used as denominator when assessing live birth rate.
次要结局
- Implantation Rate(3 months)
- Endometrial Thickness(1 month)
- Endometrial Volume(1 month)
- Clinical Pregnancy(3 months)
- Three-dimensional Doppler Indices From Endometrium (VFI)(1 month)
- Procedure Related Pain(Immediately after procedure)
- Ongoing Pregnancy(6 months)
- Miscarriage(9 months)
研究者
Wellington P Martins, MD
PhD
University of Sao Paulo