Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Biological pregnancy test
研究概览
简要总结
The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.
详细描述
The investigators hypothesize that cotreatment of low dose aspirin & low molecular weight heparin may improve implantation & clinical pregnancy rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 19 to 35 years;
- •Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
- •Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
- •Presence of both ovaries; ≥2 previous IVF failures
- •Good quality embryos for transfer
- •Endometrial thickness between 10 mm and 14 mm
排除标准
- •Polycystic ovary syndrome
- •Endometriosis
研究组 & 干预措施
Low Molecular Weight Heparin
Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously
干预措施: Low molecular weight heparin (Drug)
Low dose aspirin
Low dose aspirin, 75mg/day, orally
干预措施: Low dose aspirin (Drug)
Heparin & Aspirin
Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
干预措施: Heparin & aspirin (Drug)
Sodium chloride (NaCl)
Equivalent volume of NaCl 0.9%, subcutaneously
干预措施: NaCl (Other)
结局指标
主要结局
Biological pregnancy test
时间窗: 14 days
次要结局
- Fetal heart/Gestational sac(8 weeks)
研究者
Dr.Vandana Bansal
Director & Consultant
Jeevan Jyoti Hospital