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临床试验/NCT06234540
NCT06234540招募中不适用

Effect of Autologous Platelet Rich Plasma(a-PRP) Intrauterine Instillation in Infertile Women With Thin Endometrium in Frozen-thawed Embryo Transfer Cycle: a Randomized Controlled Study

Mahidol University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
endometrial thickness

研究概览

简要总结

This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles.

详细描述

At present, infertility is a major problem in Thailand. As a result, the Ministry of Public Health has to push the guidelines for using reproductive technology to play a role in increasing the population in the country. The most well-known use of reproductive technology is In vitro fertilization (IVF) has a success rate of approximately 35-40%. There are many factors affecting the success of pregnancy, one of which is the thickness of the uterine cavity.

An endometrial thickness of less than 7 mm in the middle of the menstrual cycle is called endometrial lining. Thin endometrium, which can affect pregnancy Both the rate of embryo implantation pregnancy rate and miscarriage rates In the process of IVF In practice, the appropriate and popular thickness of the uterine cavity for embryo transfer is based on a thickness greater than equal to 7 mm. This is because many studies have found that the thickness of the uterine cavity At 8 mm, this can significantly increase pregnancy rates.

Platelet Rich Plasma (PRP) is another new treatment approach. There is information and research results that show that PRP can increase the thickness of the uterine cavity. and found to help increase blood flowing to the area The uterine wall in infertile women who have a thin uterine cavity. According to a study by Chang et al., in 2015, PRP was used to increase the thickness of the uterine cavity. Found that it can increase the thickness of the uterine cavity. It also tends to increase the pregnancy rate. This is likely caused by Helping increase the number of cells cell regeneration and repair of worn out parts of body cells Through the main mechanism of PRP is adding substances that stimulate cell growth (Growth factors) and proteins that are signals between cells (Cytokines). Someone has studied and compared the levels of substances that stimulate cell growth in PRP. Compared with lymph (plasma), it was found that the levels of cell growth stimulants in PRP were 2.4-2.8 times higher than those in lymph, with statistical significance.

Moreover, the process of preparing PRP is not complicated and the prepared ingredients do not cause any harmful side effects to the body. Therefore, it can be seen from various sectors and various studies that PRP has been used to accelerate growth, such as treating hair loss or baldness. Reducing inflammation or pain in various joints Or even use it to restore beauty, nourish the skin, etc.

In this study The authors therefore attempt to demonstrate the benefits of PRP that may promote endometrial thickening in women with endometrial hyperplasia in order to achieve appropriate endometrial thickness. Received embryo transfer in the next embryo freezing cycle. In addition, in Thailand there has never been a study of increasing the thickness of the uterine cavity with PRP injections before. Therefore, the creators expect that this method may be a method that can increase the implantation rate. Embryo or clinical pregnancy rate Including reducing the rate of embryo implantation cancellations to reduce anxiety for infertile couples in Thailand.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who will undergo frozen embryo transfer (Frozen-thawed cycle)
  • Age above 18 years
  • Thai nationality
  • Have a history of cycle cancellation due to a thin endometrium <7 mm. after standard hormonal treatmetn

排除标准

  • medical conditions eg. Platelet dysfunction , vWD
  • thrombocytopenia <100,000 cell/mm3
  • Receive antiplatelet therapy
  • Uterine anomaly, cavity distortion eg submucous myoma uteri, uterine synergia, endometrial polyp

结局指标

主要结局

endometrial thickness

时间窗: day 12

compare endometrial thickness among 3 group

次要结局

  • miscarriage rate(up to 12 weeks)
  • chemical pregnancy rate(2 weeks after transfer)
  • cancellation rate(day 14)
  • endometrial thickness difference between day 8 and day 12(between day 8 and day 12)
  • clinical pregnancy rate(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sootthinan Pothisan

Infertility unit, Obstetric and gynecology department of Siriraj hospital, Mahidol university

Mahidol University

研究点 (2)

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