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临床试验/NCT04741295
NCT04741295Unknown不适用

To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation

Nanjing University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Early spontaneous abortion rate

研究概览

简要总结

In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The basal serum level of FSH was less than 10 IU / L
  • Diagnosed with adenomyosis by ultrasound
  • The first frozen thawed embryo transfer cycle, by hormone replacement protocol
  • Transfer at least one high quality frozen embryo;
  • Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.

排除标准

  • With abnormal karyotype;
  • Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium < 8mm on the day of transformation, etc;
  • PCOS, RIF patients;
  • There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;
  • There were contraindications to hormone replacement therapy and low molecular weight heparin;
  • Participating in other clinical studies;
  • Unable to follow-up

研究组 & 干预措施

Low molecular weight heparin Group

Experimental

Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support.

干预措施: Low molecular weight heparin (Drug)

结局指标

主要结局

Early spontaneous abortion rate

时间窗: Within three months after frozen embryo transfer

次要结局

未报告次要终点

研究者

发起方
Nanjing University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li-jun Ding

Professor

Nanjing University

研究点 (1)

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