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临床试验/NCT01589016
NCT01589016已完成不适用

Single Determination of Serum Activin A and Inhibin A in Predicting the Outcome of Pregnancies of Unknown Location (PUL) After IVF and Oocyte Donation.

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
levels of activin and inhibin A

研究概览

简要总结

The purpose of this study is to determine the predictive value of a single serum determination of activin A and inhibin A for the prognosis of ectopic pregnancy after in Vitro Fertilization (IVF) cycles, in both native and donated oocytes.

详细描述

Ectopic pregnancy (EP) is one of the most common pathologies seen in emergency gynaecology practice. Early diagnostic of this situation is a clinical objective because it remains an important cause of maternal morbidity and mortality worldwide. Currently, transvaginal ultrasound scan (TVS) allow ascertain the location of the pregnancy. However, the diagnosis of EP is complicated by a nonspecific clinical presentation and the inconclusive results in some cases of transvaginal ultrasound at first presentation. For this reason several biomarkers have been investigated to accurately detect the establishment of pregnancy and predict its outcome as early as possible.

These biomarkers include: markers of abnormal embryo/trophoblast growth (β-subunit of HCG, Activin A, etc), markers of abnormal corpus luteum function (progesterone, inhibin A, etc), markers of a growing pregnancy in the Fallopian tube (creatine kinase, vascular endothelial growth factor, etc), markers of inflammation and peritoneal irritation (cancer antigen 125, interleukin-6, etc), and uterine markers of normal implantation (leukaemia inhibitory factor and glycodelin). Β-HCG and progesterone are usually used in clinical practice and activin A and inhibin A have recently shown promising results.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with pregnancy of unknown location (PUL) diagnosed 22 - 27 days after oocyte retrieval, at first ultrasound routine control (A "pregnancy of unknown location" (PUL) is a term used to classify a women with a positive pregnancy test and an empty uterus with no signs of an intrauterine or extrauterine pregnancy on a transvaginal ultrasound scan.)
  • Patients with Intrauterine pregnancy : Viable intrauterine pregnancy (IUP) An intrauterine gestational sac containing a fetal pole with visible cardiac activity
  • Patients with Ectopic pregnancy (Tubal ectopic pregnancy): An empty endometrial cavity with: (i) an inhomogeneous adnexal mass or (ii) an empty extrauterine gestational sac seen as hyperechoic ring or (iii) an extrauterine gestational sac with a yolk sac and/or fetal pole with or without cardiac activity

排除标准

  • 未提供

结局指标

主要结局

levels of activin and inhibin A

时间窗: within the first two weeks after the first control of pregnancy

次要结局

  • Progesterone and BHCG(within the first two weeks after the first control of pregnancy)

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Giles

Gynaecologist IVI Valencia

Instituto Valenciano de Infertilidad, IVI VALENCIA

研究点 (1)

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