Lovenox With Aspirin in Thawed Blastocyst Transfer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Serum hCG level
研究概览
简要总结
This prospective randomized trial will compare outcomes in patients receiving aspirin in combination with a low-molecular weight heparin and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.
详细描述
This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low-molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer.
- •Use of pre-implantation genetically tested (PGT) blastocysts is allowed but not required.
- •Use of donated embryos or embryos derived from donated eggs is allowed.
- •Prior history of successful, failed, and/or canceled IVF cycles are allowed.
排除标准
- •Minor (age<18 years).
- •Currently pregnant.
- •Unable to provide informed consent in English.
- •Gestational carrier or "surrogate".
- •Blastocysts frozen at another center (Oocytes frozen elsewhere is acceptable).
- •Subject intending or having "natural cycle" thaw transfer with an active ovarian follicle present.
- •Currently participating in any other research study.
- •Subject already had an embryo transfer under this study.
- •History of thrombocytopenia (reduced platelets), bleeding disorders, or routinely using anti-coagulant medication.
- •Hypersensitivity to aspirin, heparin, or benzyl alcohol.
- •Anyone for whom the physician assesses this protocol is inappropriate or unsafe.
研究组 & 干预措施
Treatment Arm
Patients randomized to receive aspirin and Lovenox will begin taking one "low dose" 81mg aspirin and one 40mg injection of Lovenox daily, on the day of progesterone start.
干预措施: Lovenox (Drug)
Treatment Arm
Patients randomized to receive aspirin and Lovenox will begin taking one "low dose" 81mg aspirin and one 40mg injection of Lovenox daily, on the day of progesterone start.
干预措施: Aspirin (Drug)
Treatment Arm
Patients randomized to receive aspirin and Lovenox will begin taking one "low dose" 81mg aspirin and one 40mg injection of Lovenox daily, on the day of progesterone start.
干预措施: Embryo transfer (Procedure)
Control Arm
This arm receives neither medication.
干预措施: Embryo transfer (Procedure)
结局指标
主要结局
Serum hCG level
时间窗: 5 days post transfer
Serum hCG level
次要结局
未报告次要终点