Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy beyond the 20th gestational week rate
研究概览
简要总结
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.
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
- Single (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
- •History of at least two previously failed fresh embryo transfer cycles
- •All previously failed cycles to be performed in the American Hospital of Istanbul
- •Female age ≤ 38 years
- •Fresh ejaculate sperms to be used for ICSI
- •No hormonal, coagulation, or immunological disorders detected
- •Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography
- •Normal female and male peripheral karyotype
排除标准
- 未提供
研究组 & 干预措施
LMWH
Women in the LMWH arm are administered 1 mg/kg/day subcutaneously low molecular weight heparin after oocyte collection in addition to routine luteal phase support with vaginal progesterone
干预措施: low molecular weight heparin (enoxaparine sodium) (Drug)
Control
Women in the control arm are administered routine luteal phase support without the addition of LMWH
干预措施: crinone 8% gel (Drug)
结局指标
主要结局
Ongoing pregnancy beyond the 20th gestational week rate
次要结局
- Clinical pregnancy rate
- Embryo implantation rate