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临床试验/NCT04639505
NCT04639505已完成不适用

Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI

Reproductive & Genetic Hospital of CITIC-Xiangya1 个研究点 分布在 1 个国家目标入组 454 人开始时间: 2020年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
454
试验地点
1
主要终点
the AMH(CLIA) cutoff value of low and high ovarian response

研究概览

简要总结

In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay(CLIA) detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The first IVF/ICSI COH cycle;
  • the causes of infertility :fallopian tube factors and/or male factors;

排除标准

  • Endometriosis;
  • Adenomyosis;
  • PGT cycle because of the female chromosome abnormality or genetic abnormality;
  • FET cycle;
  • Malignant tumor patient.

结局指标

主要结局

the AMH(CLIA) cutoff value of low and high ovarian response

时间窗: the day of oocytes retrieved,about three months after AMH test

the poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15

次要结局

  • Number of oocytes retrieved(34-36 hours after hCG trigger,about three months after AMH test)
  • the serum AMH level(any day of the menstrual cycle, about three months after study starting)

研究者

发起方
Reproductive & Genetic Hospital of CITIC-Xiangya
申办方类型
Other
责任方
Sponsor

研究点 (1)

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