Luteal phase low molecular weight heparin in fresh non donor IVF/ICSI cycles in women with previous failed fresh IVF/ICSI cycles
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Implantation rate per embryo transfer
研究概览
简要总结
This is a prospective randomised controlled trial being conducted in ART centre of AIIMS, NEW DELHI INDIA with a sample size of 100 infertility patients (50 cases + 50 controls ). Primary purpose of study is to improve rates of conception by crossing the crucial rate limiting step of implantation. Implantation failure has been attributed to many factors and being itself a complicated process. Several lines of evidence from invivo and invitro studies suggest a beneficial effect of heparin on embryo implantation through interactions with several adhesion molecules, growth factors , cytokines and matrix metalloproteinases. so here is an effort to assess possible beneficial effect of low molecular weight heparin in previously failed IVF/ICSI cycles
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women requiring anticoagulant therapy for other medical reasons Obvious causes of implantation failure (hydrosalpinx visible on transvaginal ultrasound, fibroids distorting the uterine cavity, the absence of Grade I or Grade II embryos available for transfer) Clinical or laboratory findings of congenital or acquired thrombophilia.
- •Severe male factor infertility requiring sperm retrievals.
排除标准
- •1.women requiring anticoagulant therapy 2.obvious causes of implantation failure (untreated hydrosalpinx, fibroids, absence of grade 1 or grade 2 embryos available for transfer
- •clinical or laboratory findings of congenital or acquired thrombophilia
- •severe male factor infertility requiring surgical sprem retrievals.
结局指标
主要结局
Implantation rate per embryo transfer
时间窗: 6 weeks
clinical pregnancy rate
时间窗: 6 weeks
次要结局
- Ongoing pregnancy rate(20 weeks)