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临床试验/NCT01633528
NCT01633528已完成3 期

To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles

Royan Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年5月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Pregnancy rate

研究概览

简要总结

It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness as well, which could result in better implantation and pregnancy rates after IVF or ICSI treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on pregnancy rate following frozen embryo transfer.

详细描述

In the present randomized double-blind prospective study, the patients will be randomly assigned to the study and control groups. With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group will be given placebo. When endometrial thickness will be found between 8-14 mm, therapy with progesterone (100 mg IM daily) will be started and embryo transfer will be performed 48 to 72 hours later. Doppler ultrasonography also is done to calculate Resistive Index (RI) and Pulsatility Index (PI), the day after progesterone administration.

βHCG will be assessed 14 days after ET. If a pregnancy will be achieved, the patients in study and control groups will be instructed to continue the aspirin or placebo through 5 weeks and if the pregnancy test result will be negative, the treatment with aspirin or placebo will be stopped. The patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with "long or antagonist" protocol
  • Women who did not achieve a pregnancy following a fresh embryo transfer or women whom their embryos had not been transferred due to OHSS
  • The women who had frozen embryos available for another transfer no contraindications for aspirin

排除标准

  • The patients with history of recurrent abortion

研究组 & 干预措施

Asprin

Experimental

With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.

干预措施: Asprin (Drug)

placebo

Placebo Comparator

With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo

干预措施: placebo (Drug)

结局指标

主要结局

Pregnancy rate

时间窗: 6 weeks

evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

次要结局

  • Implantation rate(8 weeks)
  • Miscarriage rate(12 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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