NCT05578456尚未招募4 期
Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 540 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.
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
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •TPOAb>34IU/ml and/or TgAb>115IU/ml
- •≥5 follicles with average diameter lager than 14 mm at trigger day
- •≥5 oocytes retrieved
- •for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage
- •age: 20-38 years old
- •Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- •meet item 1, 5, 6, and one of item 2, 3, 4.
排除标准
- •hyperthyroidism
- •intrauterine adhesion
- •with endometrium thickness less than 6mm
- •uterine malformation
- •with other autoimmune diseases need glucocorticoid or aspirin treatment
- •gastric ulcer
研究组 & 干预措施
prednisone and aspirin
Experimental
干预措施: Prednisone and Aspirin (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 3-5 weeks after embryo transfer
ultrasound visualization of the gestational sac
次要结局
未报告次要终点
研究者
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